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Head and neck cancer (HNC) patients suffer from a range of health‐related quality of life (HRQoL) issues, but little is known about their long‐term HRQoL. This study explored associations between treatment group and HRQoL at least 5 years' post‐diagnosis in HNC survivors. In an international cross‐sectional study, HNC survivors completed the European Organization for Research and Treatment of Cancer (EORTC) quality of life core questionnaire (EORTC‐QLQ‐C30) and its HNC module (EORTC‐QLQ‐H&N35). Meaningful HRQoL differences were examined between five treatment groups: (a) surgery, (b) radiotherapy, (c) chemo‐radiotherapy, (d) radiotherapy ± chemotherapy and neck dissection and (e) any other surgery (meaning any tumour surgery that is not a neck dissection) and radiotherapy ± chemotherapy. Twenty‐six sites in 11 countries enrolled 1105 survivors. They had a median time since diagnosis of 8 years, a mean age of 66 years and 71% were male. After adjusting for age, sex, tumour site and UICC stage, there was evidence for meaningful differences (10 points or more) in HRQoL between treatment groups in seven domains (Fatigue, Mouth Pain, Swallowing, Senses, Opening Mouth, Dry Mouth and Sticky Saliva). Survivors who had single‐modality treatment had better or equal HRQoL in every domain compared to survivors with multimodal treatment, with the largest differences for Dry Mouth and Sticky Saliva. For Global Quality of Life, Physical and Social Functioning, Constipation, Dyspnoea and Financial Difficulties, at least some treatment groups had better outcomes compared to a general population. Our data suggest that multimodal treatment is associated with worse HRQoL in the long‐term compared to single modality. [ABSTRACT FROM AUTHOR]

Objective: To investigate utilization of mental healthcare among head and neck cancer (HNC) patients from diagnosis to 2 years after treatment, in relation to psychological symptoms, mental disorders, need for mental healthcare, and sociodemographic, clinical and personal factors. Methods: Netherlands Quality of life and Biomedical Cohort study data as measured before treatment, at 3 and 6 months, and at 1 and 2 years after treatment was used (n = 610). Data on mental healthcare utilization (iMCQ), psychological symptoms (Hospital Anxiety and Depression Scale, Cancer Worry Scale), mental disorders (CIDI interview), need for mental healthcare (Supportive Care Needs Survey Short‐Form 34, either as continuous outcome indicating the level of need or dichotomized into unmet need (yes/no)) and several sociodemographic, clinical and personal factors were collected. Factors associated with mental healthcare utilization were investigated using generalized estimating equations (p < 0.05). Results: Of all HNC patients, 5%–9% used mental healthcare per timepoint. This was 4%–14% in patients with mild‐severe psychological symptoms, 4%–17% in patients with severe psychological symptoms, 15%–35% in patients with a mental disorder and 5%–16% in patients with an unmet need for mental healthcare. Among all patients, higher symptoms of anxiety, a higher need for mental healthcare, lower age, higher disease stage, lower self‐efficacy and higher social support seeking were significantly associated with mental healthcare utilization. Conclusion: Mental health care utilization among HNC patients is limited, and is related to psychological symptoms, need for mental healthcare, and sociodemographic, clinical and personal factors. [ABSTRACT FROM AUTHOR]

Land cover controls the land‐atmosphere exchange of water and energy through the partitioning of solar energy into latent and sensible heat. Observations over all land cover types at the regional scale are required to study these turbulent flux dynamics over a landscape. Here, we aim to study how the control of daily and midday latent and sensible heat fluxes over different land cover types is distributed along three axes: energy availability, water availability and exchange efficiency. To this end, observations from 19 eddy covariance flux tower sites in the Netherlands, covering six different land cover types located within the same climatic zone, were used in a regression analysis to explain the observed dynamics and find the principle drivers. The resulting relative position of these sites along the three axes suggests that land cover partly explains the variance of daily and midday turbulent fluxes. We found that evaporation dynamics from grassland, peatland swamp and cropland sites could mostly be explained by energy availability. Forest evaporation can mainly be explained by water availability, urban evaporation by water availability and exchange efficiency, and open water evaporation can almost entirely be explained by exchange efficiency. We found that the sensible heat flux is less sensitive to land cover type. This demonstrates that the land‐atmosphere interface plays an active role in the shedding of sensible heat. Our results contribute to a better understanding of the dynamics of evaporation over different land cover types and may help to optimize, and potentially simplify, models to predict evaporation. Plain Language Summary: At the land surface solar energy is divided into evaporation and warming of the air (sensible heat). Land cover controls the land‐atmosphere exchange of water and energy through this division. Over the past years, there is a growing interest in how land use management can be used to optimize local water and climate services by influencing this division. However, this requires a good understanding of the drivers of evaporation and sensible heat. In this study, we aim to study the role of land cover type on the drivers of daily and midday evaporation and sensible heat during warm seasons. Therefore, we used fields observations, the eddy covariance technique, from 19 sites in the Netherlands covering six different land cover types in a regression analysis. The drivers are expressed along three axes: energy availability, water availability and exchange efficiency. We found that evaporation dynamics from grassland, peatland swamp and cropland sites could mostly be explained by energy availability. Forest evaporation can mainly be explained by water availability, urban evaporation by water availability and exchange efficiency, and open water evaporation can almost entirely be explained by exchange efficiency. We also found that sensible heat fluxes are less sensitive to land cover type. Key Points: The drivers of latent and sensible heat fluxes in the Netherlands were studied over various land cover types based on regression analysesDrivers of evaporation associated with energy availability, water availability, exchange efficiency vary substantially per land cover typeIn natural landscape mosaics limitation of evaporation by water availability, energy availability and exchange efficiency coexist [ABSTRACT FROM AUTHOR]

Simple Summary: Many head and neck cancer patients report sexual problems. A deterioration in sexuality and sexual dysfunction from baseline to 3 months after treatment was observed especially in patients treated with chemoradiation. This effect seems to differ between men and women. Men reported change in erectile function, orgasm, satisfaction with intercourse, and overall satisfaction, while women reported change in desire, arousal, and orgasm. These findings are helpful to improve information on sexuality and sexual care in head and neck cancer patients. The aim of this study was to investigate changes in sexuality and sexual dysfunction in head and neck cancer (HNC) patients in the first two years after treatment, in relation to the type of treatment. Data were used of 588 HNC patients participating in the prospective NETherlands Quality of life and Biomedical Cohort Study (NET-QUBIC) from diagnosis to 3, 6, 12 and 24 months after treatment. Primary outcome measures were the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI). The total scores of the IIEF and FSFI were dichotomized into sexual (dys)function. In men, type of treatment was significantly associated with change in erectile function, orgasm, satisfaction with intercourse, and overall satisfaction. In women, type of treatment was significantly associated with change in desire, arousal, and orgasm. There were significant differences between treatment groups in change in dysfunctional sexuality. A deterioration in sexuality and sexual dysfunction from baseline to 3 months after treatment was observed especially in patients treated with chemoradiation. Changes in sexuality and sexual dysfunction in HNC patients were related to treatment, with an acute negative effect of chemoradiation. This effect on the various domains of sexuality seems to differ between men and women. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this prospective cohort study was to estimate the relationship between the course of HRQOL in the first 2 years after diagnosis and treatment of head and neck cancer (HNC) and personal, clinical, psychological, physical, social, lifestyle, HNC-related, and biological factors. Methods: Data were used from 638 HNC patients of the NETherlands QUality of life and BIomedical Cohort study (NET-QUBIC). Linear mixed models were used to investigate factors associated with the course of HRQOL (EORTC QLQ-C30 global quality of life (QL) and summary score (SumSc)) from baseline to 3, 6, 12, and 24 months after treatment. Results: Baseline depressive symptoms, social contacts, and oral pain were significantly associated with the course of QL from baseline to 24 months. Tumor subsite and baseline social eating, stress (hyperarousal), coughing, feeling ill, and IL-10 were associated with the course of SumSc. Post-treatment social contacts and stress (avoidance) were significantly associated with the course of QL from 6 to 24 months, and social contacts and weight loss with the course of SumSc. The course of SumSc from 6 to 24 months was also significantly associated with a change in financial problems, speech problems, weight loss, and shoulder problems between baseline and 6 months. Conclusion: Baseline clinical, psychological, social, lifestyle, HNC-related, and biological factors are associated with the course of HRQOL from baseline to 24 months after treatment. Post-treatment social, lifestyle, and HNC-related factors are associated with the course of HRQOL from 6 to 24 months after treatment. [ABSTRACT FROM AUTHOR]

Objective: Informal caregivers of head and neck cancer (HNC) patients have a high caregiver burden and often face complex practical caregiving tasks. This may result in unmet supportive care needs, which can impact their quality of life (QoL) and cause psychological distress. In this study, we identify caregivers’ unmet needs during long-term follow-up and identify caregivers prone to unmet supportive care needs. Methods: Data were used from the multicenter prospective cohort study NETherlands QUality of life and Biomedical cohort studies In Cancer (NET-QUBIC). The unmet supportive care needs, psychological distress, caregiver burden, and QoL were measured for 234 informal caregivers and their related patients at baseline, 3, 6, 12, and 24 months after. Mixed effect models for repeated measurements were used. Results: At baseline, most caregivers (70.3%) reported at least one unmet supportive care need, with most of the identified needs in the “healthcare & illness” domain. During the follow-up period, caregivers’ unmet needs decreased significantly in all domains. Nevertheless, 2 years after treatment, 28.3% were still reporting at least one unmet need. Financial problems were increasingly associated with unmet needs over time. Furthermore, caring for a patient who themselves had many unmet needs, an advanced tumor stage, or severe comorbidity was associated with significantly more unmet needs in caregivers. Conclusions: The current study shows the strong likelihood of caregivers of HNC patients facing unmet supportive care needs and the interaction between the needs of patients and caregivers. It is important to optimally support informal caregivers by involving them from the start when counseling patients, by providing them with relevant and understandable information, and by referring vulnerable caregivers for (psychosocial) support. [ABSTRACT FROM AUTHOR]

The long-term problems of head and neck cancer survivors (HNCS) are not well known. In a cross-sectional international study aimed at exploring the long-term quality of life in this population, 1114 HNCS were asked to state their two most serious long-term effects. A clinician recorded the responses during face-to-face appointments. A list of 15 example problems was provided, but a free text field was also available. A total of 1033 survivors responded to the question. The most frequent problems were 'dry mouth' (DM) (n = 476; 46%), 'difficulty swallowing/eating' (DSE) (n = 408; 40%), 'hoarseness/difficulty speaking' (HDS) (n = 169; 16%), and 'pain in the head and neck' (PHN) (n = 142; 14%). A total of 5% reported no problems. Logistic regression adjusted for age, gender, treatment, and tumor stage and site showed increased odds of reporting DM and DSE for chemo-radiotherapy (CRT) alone compared to surgery alone (odds ratio (OR): 4.7, 95% confidence interval (CI): 2.5–9.0; OR: 2.1, CI: 1.1–3.9), but decreased odds for HDS and PHN (OR: 0.3, CI: 0.1–0.6; OR: 0.2, CI: 0.1–0.5). Survivors with UICC stage IV at diagnosis compared to stage I had increased odds of reporting HDS (OR: 1.9, CI: 1.2–3.0). Laryngeal cancer survivors had reduced odds compared to oropharynx cancer survivors of reporting DM (OR: 0.4, CI: 0.3–0.6) but increased odds of HDS (OR: 7.2, CI: 4.3–12.3). This study provides evidence of the serious long-term problems among HNCS. [ABSTRACT FROM AUTHOR]

Simple Summary: Social eating problems may affect lives of people with head and neck cancer (HNC) during and after (chemo)radiotherapy treatment. This study aimed at investigating if people with HNC experience social eating problems from diagnosis up to 24 months after (chemo)radiotherapy and if their change over time is associated with swallowing, oral function, and nutritional status, in addition to the clinical, personal, physical, psychological, social, and lifestyle dimensions. We found that social eating problems worsened three months after treatment and improved to baseline levels up to 24 months. The change in social eating problems over time was associated with swallowing, nutritional status, tumor subsite, age, muscle strength, hearing problems, and depressive symptoms. Results are relevant to research and clinical practice for improving personalized supportive care targeting social eating problems. This study aimed at investigating the change in social eating problems from diagnosis to 24 months after primary (chemo)radiotherapy and its associations with swallowing, oral function, and nutritional status, in addition to the clinical, personal, physical, psychological, social, and lifestyle dimensions. Adult patients from the NETherlands QUality of life and BIomedical Cohort (NET-QUBIC) treated with curative intent with primary (chemo)radiotherapy for newly-diagnosed HNC and who provided baseline social eating data were included. Social eating problems were measured at baseline and at 3-, 6-, 12-, and 24-month follow-up, with hypothesized associated variables at baseline and at 6 months. Associations were analyzed through linear mixed models. Included patients were 361 (male: 281 (77.8%), age: mean = 63.3, SD = 8.6). Social eating problems increased at the 3-month follow-up and decreased up to 24 months (F = 33.134, p < 0.001). The baseline-to-24 month change in social eating problems was associated with baseline swallowing-related quality of life (F = 9.906, p < 0.001) and symptoms (F = 4.173, p = 0.002), nutritional status (F = 4.692, p = 0.001), tumor site (F = 2.724, p = 0.001), age (F = 3.627, p = 0.006), and depressive symptoms (F = 5.914, p < 0.001). The 6–24-month change in social eating problems was associated with a 6-month nutritional status (F = 6.089, p = 0.002), age (F = 5.727, p = 0.004), muscle strength (F = 5.218, p = 0.006), and hearing problems (F = 5.155, p = 0.006). Results suggest monitoring social eating problems until 12-month follow-up and basing interventions on patients' features. [ABSTRACT FROM AUTHOR]

Objective: In order to understand how informal caregivers of head and neck cancer (HNC) patients deal with the consequences of the disease, we investigated their self-efficacy and coping style in relation to symptoms of anxiety and depression (distress) and quality of life (QoL) over time. In addition, factors associated with self-efficacy and coping style were investigated. Methods: A total of 222 informal caregivers and their related HNC patients were prospectively followed as part from the multicenter cohort NETherlands QUality of life and Biomedical cohort studies In Cancer (NET-QUBIC). Self-efficacy and coping style were measured at baseline, and distress and QoL at baseline and 3, 6, 12, and 24 months after treatment. Results: Informal caregivers had a high level of self-efficacy comparable with patients. Caregivers used “seeking social support,” “passive reacting,” and “expression of emotions” more often than patients. Factors associated with self-efficacy and coping were higher age and lower education. Higher self-efficacy was related with better QoL and “active tackling” was associated with less depression symptoms. “Passive reacting” and “expression of emotions” were associated with higher psychological distress and reduced QoL. Conclusion: Among informal caregivers of HNC patients, higher self-efficacy and “active tackling” were associated with better functioning over time, while “passive reacting” and “expression of negative emotions” were associated with worse functioning. Awareness of the differences in self-efficacy skills and coping and their relationship with QoL and psychological distress will help clinicians to identify caregivers that may benefit from additional support that improve self-efficacy and “active tackling” and reduce negative coping styles. [ABSTRACT FROM AUTHOR]

Purpose: Many partners of incurably ill cancer patients experience caregiver burden. The eHealth application "Oncokompas" supports these partners to manage their caregiver needs and to find optimal supportive care for themselves. The aim of this randomized controlled trial (RCT) was to investigate the reach of Oncokompas and its efficacy on caregiver burden, self-efficacy, and health-related quality of life (HRQOL). Methods: The reach was estimated based on eligibility, participation rate, and an evaluation of the recruitment process. Efficacy on caregiver burden was measured using the Caregiver Strain Index + (CSI +). Secondary outcomes were self-efficacy (General Self-Efficacy Scale (GSE)) and HRQOL (EQ-5D VAS). Assessments were scheduled at baseline, 2 weeks after randomization and 3 months after baseline. Linear mixed models were used to compare longitudinal changes between the experimental and control group from baseline to the 3-month follow-up. Results: The reach, in terms of eligibility and participation rate, was estimated at 83–91%. Partners were most likely reached via palliative care consultants, patient organizations, and palliative care networks. In the one-and-a-half-year recruitment period and via the 101 organizations involved, 58 partners were included. There were no significant effects of Oncokompas on caregiver burden, self-efficacy, or HRQOL. Conclusion: The reach of Oncokompas among interested individuals was high, but the difficulties that were encountered to include partners suggest that the reach in real life may be lower. This study showed no effect of Oncokompas on caregiver burden, self-efficacy, or HRQOL in partners of incurably ill cancer patients. Relevance: The results of this study may be used in the process of developing, efficacy testing, and implementing eHealth applications for caregivers of incurably ill cancer patients. Trial registration: Netherlands Trial Register identifier: NTR7636/NL7411. Registered on November 23, 2018 (https://www.trialregister.nl/). [ABSTRACT FROM AUTHOR]

Introduction: Head and neck cancer (HNC) and its treatment often negatively impact swallowing function. The aim was to investigate the course of patient-reported swallowing problems from diagnosis to 3, 6, 12, and 24 months after treatment, in relation to demographic, clinical, and lifestyle factors. Methods: Data were used of the Netherlands Quality of Life and Biomedical Cohort Study in head and neck cancer research (NET-QUBIC). The primary outcome measures were the subscales of the Swallowing Quality of Life Questionnaire (SWAL-QOL). Linear mixed-effects models (LMM) were conducted to investigate changes over time and associations with patient, clinical, and lifestyle parameters as assessed at baseline. Results: Data were available of 603 patients. There was a significant change over time on all subscales. Before treatment, 53% of patients reported swallowing problems. This number increased to 70% at M3 and decreased to 59% at M6, 50% at M12, and 48% at M24. Swallowing problems (i.e., longer eating duration) were more pronounced in the case of female, current smoking, weight loss prior to treatment, and stage III or IV tumor, and were more prevalent at 3 to 6 months after treatment. Especially patients with an oropharynx and oral cavity tumor, and patients receiving (C)RT following surgery or CRT only showed a longer eating duration after treatment, which did not return to baseline levels. Conclusion: Half of the patients with HNC report swallowing problems before treatment. Eating duration was associated with sex, smoking, weight loss, tumor site and stage, and treatment modality, and was more pronounced 3 to 6 months after treatment. [ABSTRACT FROM AUTHOR]

We study the controls on open water evaporation of a large lowland reservoir in the Netherlands. To this end, we analyse the dynamics of open water evaporation at two locations, Stavoren and Trintelhaven, at the border of Lake IJssel (1100 km 2); eddy covariance systems were installed at these locations during the summer seasons of 2019 and 2020. These measurements were used to develop data-driven models for both locations. Such a statistical model is a clean and simple approach that can provide a direct indication of (and insight into) the most relevant input parameters involved in explaining the variance in open water evaporation, without making a priori assumptions regarding the process itself. We found that a combination of wind speed and the vertical vapour pressure gradient can explain most of the variability in observed hourly open water evaporation. This is in agreement with Dalton's model, which is a well-established model often used in oceanographic studies for calculating open water evaporation. Validation of the data-driven models demonstrates that a simple model using only two variables yields satisfactory results at Stavoren, with R2 values of 0.84 and 0.78 for hourly and daily data respectively. However, the validation results for Trintelhaven fall short, with R2 values of 0.67 and 0.65 for hourly and daily data respectively. Validation of the simple models that only use routinely measured meteorological variables shows adequate performance at hourly (R2=0.78 at Stavoren and R2=0.51 at Trintelhaven) and daily (R2=0.82 at Stavoren and R2=0.87 at Trintelhaven) timescales. These results for the summer periods show that open water evaporation is not directly coupled to global radiation at the hourly or daily timescale. Rather a combination of wind speed and vertical gradient of vapour pressure is the main driver at these timescales. We would like to stress the importance of including the correct drivers of open water evaporation in the parametrization in hydrological models in order to adequately represent the role of evaporation in the surface–atmosphere coupling of inland waterbodies. [ABSTRACT FROM AUTHOR]

Psychoneurological symptoms are commonly reported by newly diagnosed head and neck cancer (HNC) patients, yet there is limited research on the associations of these symptoms with biomarkers of stress and inflammation. In this article, pre-treatment data of a multi-center cohort of HNC patients were analyzed using a network analysis to examine connections between symptoms (poor sleep quality, anxiety, depression, fatigue, and oral pain), biomarkers of stress (diurnal cortisol slope), inflammation markers (c-reactive protein [CRP], interleukin [IL]-6, IL-10, and tumor necrosis factor alpha [TNF-α]), and covariates (age and body mass index [BMI]). Three centrality indices were calculated: degree (number of connections), closeness (proximity of a variable to other variables), and betweenness (based on the number of times a variable is located on the shortest path between any pair of other variables). In a sample of 264 patients, poor sleep quality and fatigue had the highest degree index; fatigue and CRP had the highest closeness index; and IL-6 had the highest betweenness index. The model yielded two clusters: a symptoms—cortisol slope—CRP cluster and a IL-6—IL-10—TNF-α—age—BMI cluster. Both clusters were connected most prominently via IL-6. Our findings provide evidence that poor sleep quality, fatigue, CRP, and IL-6 play an important role in the interconnections between psychoneurological symptoms and biomarkers of stress and inflammation in newly diagnosed HNC patients. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effect of implant-based dental rehabilitation (IDR) on health-related quality of life (HRQoL) in head and neck cancer (HNC) patients after reconstruction with a free vascularized fibula flap (FFF).Methods: Eligible patients were identified by retrospectively reviewing the medical records of patients treated in Amsterdam UMC-VUmc. HRQoL data were used from OncoQuest, a hospital-based system to collect patient-reported outcome measures in routine care. Data were used of the EORTC QLQ-C30 and QLQ-H&N 35 before FFF reconstruction (T0) and after completing IDR (T1). Data were statistically analysed with the chi-square test, independent samples t test and linear mixed models.Results: Out of 96 patients with maxillofacial FFF reconstruction between January 2006 and October 2017, 57 patients (19 with and 38 without IDR) had HRQoL data at T0 and T1. In the cross-sectional analysis, patients with IDR scored significantly better at T0 and T1 on several EORTC domains compared to the patients without IDR. Weight loss was significantly different in the within-subject analysis between T0 and T1 for patients with IDR (p = 0.011). However, there were no significant differences in the mean changes of all the EORTC QLQ-C30 and EORTC QLQ-H&N35 scores between the defined timepoints for patients with IDR compared to those without.Conclusions: In this study, no differences were found in the course of HRQoL in HNC patients who had undergone IDR after maxillofacial FFF reconstruction, compared to those who had not. Patients should be preoperatively informed to have realistic expectations regarding the outcome of IDR. [ABSTRACT FROM AUTHOR]

Background: To investigate associations between psychological problems and the use of healthcare and informal care and total costs among head and neck cancer (HNC) patients. Method: Data were used of the NETherlands QUality of Life and Biomedical Cohort study. Anxiety and depression disorder (diagnostic interview), distress, symptoms of anxiety and depression (HADS), and fear of cancer recurrence (FCR) and cancer worry scale (CWS) were measured at baseline and at 12-month follow-up. Care use and costs (questionnaire) were measured at baseline, 3-, 6-, 12-, and 24-month follow-up. Associations between psychological problems and care use/costs were investigated using logistic and multiple regression analyses. Results: Data of 558 patients were used. Distress, symptoms of anxiety or depression, FCR, and/or anxiety disorder at baseline were significantly associated with higher use of primary care, supportive care, and/or informal care (odds ratios (ORs) between 1.55 and 4.76). Symptoms of anxiety, FCR, and/or depression disorder at 12-month follow-up were significantly associated with use of primary care, supportive care, and/or informal care (ORs between 1.74 and 6.42). Distress, symptoms of anxiety, and FCR at baseline were associated with higher total costs. Discussion: HNC patients with psychological problems make more use of healthcare and informal care and have higher costs. This is not the result of worse clinical outcomes. [ABSTRACT FROM AUTHOR]

Background: This study assessed the course of fear of cancer recurrence (FCR) in patients newly diagnosed with head and neck cancer (HNC), identified FCR trajectories and factors associated with FCR trajectories. Methods: Six hundred and seventeen HNC patients from the NET‐QUBIC cohort study completed the Cancer Worry Scale‐6 at diagnosis, 3 and 6 months post‐treatment. FCR trajectories were identified using Latent Class Growth Analysis. Associations were explored between FCR trajectories and baseline demographic and medical variables, coping and self‐efficacy. Results: Overall, FCR decreased slightly between baseline and 3 months post‐treatment and remained stable up to 6 months. Two FCR trajectories were identified: "high stable" (n = 125) and "low declining" (n = 492). Patients with high stable FCR were younger, reported more negative adjustment, passive coping, and reassuring thoughts, and less avoidance. Conclusions: The majority of HNC patients have low declining FCR after diagnosis, but one in five patients experience persistent high FCR up to 6 months post‐treatment. [ABSTRACT FROM AUTHOR]

STUDY QUESTION How should endometriosis be diagnosed and managed based on the best available evidence from published literature? SUMMARY ANSWER The current guideline provides 109 recommendations on diagnosis, treatments for pain and infertility, management of disease recurrence, asymptomatic or extrapelvic disease, endometriosis in adolescents and postmenopausal women, prevention and the association with cancer. WHAT IS KNOWN ALREADY Endometriosis is a chronic condition with a plethora of presentations in terms of not only the occurrence of lesions, but also the presence of signs and symptoms. The most important symptoms include pain and infertility. STUDY DESIGN, SIZE, DURATION The guideline was developed according to the structured methodology for development of ESHRE guidelines. After formulation of key questions by a group of experts, literature searches and assessments were performed. Papers published up to 1 December 2020 and written in English were included in the literature review. PARTICIPANTS/MATERIALS, SETTING, METHODS Based on the collected evidence, recommendations were formulated and discussed within specialist subgroups and then presented to the core guideline development group (GDG) until consensus was reached. A stakeholder review was organized after finalization of the draft. The final version was approved by the GDG and the ESHRE Executive Committee. MAIN RESULTS AND THE ROLE OF CHANCE This guideline aims to help clinicians to apply best care for women with endometriosis. Although studies mostly focus on women of reproductive age, the guideline also addresses endometriosis in adolescents and postmenopausal women. The guideline outlines the diagnostic process for endometriosis, which challenges laparoscopy and histology as gold standard diagnostic tests. The options for treatment of endometriosis-associated pain symptoms include analgesics, medical treatments and surgery. Non-pharmacological treatments are also discussed. For management of endometriosis-associated infertility, surgical treatment and/or medically assisted reproduction are feasible. While most of the more recent studies confirm previous ESHRE recommendations, there are five topics in which significant changes to recommendations were required and changes in clinical practice are to be expected. LIMITATIONS, REASONS FOR CAUTION The guideline describes different management options but, based on existing evidence, no firm recommendations could be formulated on the most appropriate treatments. Also, for specific clinical issues, such as asymptomatic endometriosis or extrapelvic endometriosis, the evidence is too scarce to make evidence-based recommendations. WIDER IMPLICATIONS OF THE FINDINGS The guideline provides clinicians with clear advice on best practice in endometriosis care, based on the best evidence currently available. In addition, a list of research recommendations is provided to stimulate further studies in endometriosis. STUDY FUNDING/COMPETING INTEREST(S) The guideline was developed and funded by ESHRE, covering expenses associated with the guideline meetings, with the literature searches and with the dissemination of the guideline. The guideline group members did not receive payments. C.M.B. reports grants from Bayer Healthcare and the European Commission; Participation on a Data Safety Monitoring Board or Advisory Board with ObsEva (Data Safety Monitoring Group) and Myovant (Scientific Advisory Group). A.B. reports grants from FEMaLE executive board member and European Commission Horizon 2020 grant; consulting fees from Ethicon Endo Surgery, Medtronic; honoraria for lectures from Ethicon; and support for meeting attendance from Gedeon Richter; A.H. reports grants from MRC, NIHR, CSO, Roche Diagnostics, Astra Zeneca, Ferring; Consulting fees from Roche Diagnostics, Nordic Pharma, Chugai and Benevolent Al Bio Limited all paid to the institution; a pending patent on Serum endometriosis biomarker; he is also Chair of TSC for STOP-OHSS and CERM trials. O.H. reports consulting fees and speaker's fees from Gedeon Richter and Bayer AG; support for attending meetings from Gedeon-Richter, and leadership roles at the Finnish Society for Obstetrics and Gynecology and the Nordic federation of the societies of obstetrics and gynecology. L.K. reports consulting fees from Gedeon Richter, AstraZeneca, Novartis, Dr KADE/Besins, Palleos Healthcare, Roche, Mithra; honoraria for lectures from Gedeon Richter, AstraZeneca, Novartis, Dr KADE/Besins, Palleos Healthcare, Roche, Mithra; support for attending meetings from Gedeon Richter, AstraZeneca, Novartis, Dr KADE/Besins, Palleos Healthcare, Roche, Mithra; he also has a leadership role in the German Society of Gynecological Endocrinology (DGGEF). M.K. reports grants from French Foundation for Medical Research (FRM), Australian Ministry of Health, Medical Research Future Fund and French National Cancer Institute; support for meeting attendance from European Society for Gynaecological Endoscopy (ESGE), European Congress on Endometriosis (EEC) and ESHRE; She is an advisory Board Member, FEMaLe Project (Finding Endometriosis Using Machine Learning), Scientific Committee Chair for the French Foundation for Research on Endometriosis and Scientific Committee Chair for the ComPaRe-Endometriosis cohort. A.N. reports grants from Merck SA and Ferring; speaker fees from Merck SA and Ferring; support for meeting attendance from Merck SA; Participation on a Data Safety Monitoring Board or Advisory Board with Nordic Pharma and Merck SA; she also is a board member of medical advisory board, Endometriosis Society, the Netherlands (patients advocacy group) and an executive board member of the World Endometriosis Society. E.S. reports grants from National Institute for Health Research UK, Rosetrees Trust, Barts and the London Charity; Royalties from De Gruyter (book editor); consulting fees from Hologic; speakers fees from Hologic, Johnson & Johnson, Medtronic, Intuitive, Olympus and Karl Storz; Participation in the Medicines for Women's Health Expert Advisory Group with Medicines and Healthcare Products Regulatory Agency (MHRA); he is also Ambassador for the World Endometriosis Society. C.T. reports grants from Merck SA; Consulting fees from Gedeon Richter, Nordic Pharma and Merck SA; speaker fees from Merck SA, all paid to the institution; and support for meeting attendance from Ferring, Gedeon Richter and Merck SA. The other authors have no conflicts of interest to declare. DISCLAIMER This guideline represents the views of ESHRE, which were achieved after careful consideration of the scientific evidence available at the time of preparation. In the absence of scientific evidence on certain aspects, a consensus between the relevant ESHRE stakeholders has been obtained. Adherence to these clinical practice guidelines does not guarantee a successful or specific outcome, nor does it establish a standard of care. Clinical practice guidelines do not replace the need for application of clinical judgement to each individual presentation, nor variations based on locality and facility type. ESHRE makes no warranty, express or implied, regarding the clinical practice guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose (Full disclaimer available at www.eshre.eu/guidelines.). [ABSTRACT FROM AUTHOR]

Background: Neurocognition and speech, relevant domains in head and neck cancer (HNC), may be affected pretreatment. However, the prevalence of pretreatment deficits and their possible concurrent predictors are poorly understood. Methods: Using an HNC prospective cohort (Netherlands Quality of Life and Biomedical Cohort Study, N ≥ 444) with a cross‐sectional design, we investigated the estimated prevalence of pretreatment deficits and their relationship with selected demographic, behavioral, and disease‐related factors. Results: Using objective assessments, rates of moderate‐to‐severe neurocognitive deficit ranged between 4% and 8%. From patient‐reported outcomes, 6.5% of patients reported high levels of cognitive failures and 46.1% reported speech deficits. Patient‐reported speech functioning was worse in larynx compared to other subsites. Other nonspeech outcomes were unrelated to any variable. Patient‐reported neurocognitive and speech functioning were modestly correlated, especially in the larynx group. Conclusions: These findings indicate that a subgroup of patients with HNC shows pretreatment deficits, possibly accentuated in the case of larynx tumors. [ABSTRACT FROM AUTHOR]

Objectives: Investigating supportive care (SC) needs and utilization/willingness to use SC services from diagnosis to one year after radical cystectomy in bladder cancer (BC) patients. Materials & Methods: A longitudinal cohort study was conducted in 90 BC patients at Ghent/Leuven University Hospitals between April 2017 and December 2020. The Supportive Care Needs Survey‐short form (SCNS‐SF34) was used before radical cystectomy, one, three, six and 12 months after radical cystectomy. Additional questions assessed utilization/willingness to use SC services. Linear mixed models were performed. Results: The majority of BC patients report at least one moderate or high SC need at diagnosis (82%), month 1 (84%), month 3 (86%), month 6 (64%), and month 12 (60%). Significant decreases over time were seen for all domains (p < 0.001), except for sexuality (p = 0.275). From baseline to month 1, physical needs first significantly increased (p = 0.001) after which they decreased. Psychological (e.g. fears about the future) and informational (e.g. information on how to get better) needs were most common at baseline whereas physical (e.g. lack of energy) and informational needs were more common in the early postoperative phases. The majority of patients (ranging from 81% (month 1) to 91% (month 12)) did not make use of SC services and the majority of the patients (ranging from 81% (month 1) to 88% (month 12)) did not wish to talk about their problems to someone. Those willing to talk to someone preferred their physician. Conclusions: A clear gap exists between the large proportion of SC needs experienced by BC patients undergoing radical cystectomy and the low use of SC services. [ABSTRACT FROM AUTHOR]

Background: Longitudinal observational cohort studies in cancer patients are important to move research and clinical practice forward. Continued study participation (study retention) is of importance to maintain the statistical power of research and facilitate representativeness of study findings. This study aimed to investigate study retention and attrition (drop-out) and its associated sociodemographic and clinical factors among head and neck cancer (HNC) patients and informal caregivers included in the Netherlands Quality of Life and Biomedical Cohort Study (NET-QUBIC).Methods: NET-QUBIC is a longitudinal cohort study among 739 HNC patients and 262 informal caregivers with collection of patient-reported outcome measures (PROMs), fieldwork data (interview, objective tests and medical examination) and biobank materials. Study retention and attrition was described from baseline (before treatment) up to 2-years follow-up (after treatment). Sociodemographic and clinical characteristics associated with retention in NET-QUBIC components at baseline (PROMs, fieldwork and biobank samples) and retention in general (participation in at least one component) were investigated using Chi-square, Fisher exact or independent t-tests (p< 0.05).Results: Study retention at 2-years follow-up was 80% among patients alive (66% among all patients) and 70% among caregivers of patients who were alive and participating (52% among all caregivers). Attrition was most often caused by mortality, and logistic, physical, or psychological-related reasons. Tumor stage I/II, better physical performance and better (lower) comorbidity score were associated with participation in the PROMs component among patients. No factors associated with participation in the fieldwork component (patients), overall sample collection (patients and caregivers) or PROMs component (caregivers) were identified. A better performance and comorbidity score (among patients) and higher age (among caregivers) were associated with study retention at 2-years follow-up.Conclusions: Retention rates were high at two years follow-up (i.e. 80% among HNC patients alive and 70% among informal caregivers with an active patient). Nevertheless, some selection was shown in terms of tumor stage, physical performance, comorbidity and age, which might limit representativeness of NET-QUBIC data and samples. To facilitate representativeness of study findings future cohort studies might benefit from oversampling specific subgroups, such as patients with poor clinical outcomes or higher comorbidity and younger caregivers. [ABSTRACT FROM AUTHOR]

Evaporation forms a large loss term in the water balance of inland water bodies. During summer seasons, which are projected to become warmer with more severe and prolonged periods of drought, the combination of high evaporation rates and increasing demand on freshwater resources forms a challenge for water managers. Correct parameterisation of open water evaporation is crucial to include in operational hydrological models to make well supported predictions of the loss of water through evaporation. Here, we aim to study the controls on open water evaporation of a large lowland reservoir in the Netherlands. To this end, we analyse the dynamics of open water evaporation at two locations, i.e. Stavoren and Trintelhaven, at the border of Lake IJssel (1100 km2) where eddy covariance systems were installed during the summer seasons of 2019 and 2020. From these measurements we find that wind speed and the vertical vapour pressure gradient, but not available energy, can explain most of the variability of observed hourly open water evaporation. This is in agreement with Dalton's model which is a well-established model often used in oceanographic studies for calculating open water evaporation. At the daily timescale, we find that wind speed and water temperature are the main drivers in Stavoren. These observed driving variables of open water evaporation are used to develop simple data-driven models for both measurement locations. Validation of these models demonstrates that a simple model using only two variables, performs well both at the hourly timescale (R2 = 0.84 in Stavoren, and R2 = 0.67 in Trintelhaven), and at the daily timescale (R2 = 0.72 in Stavoren, and R2 = 0.51 in Trintelhaven). Using only routinely measured meteorological variables leads to well performing simple data-driven models at hourly (R2 = 0.78 in Stavoren, and R2 = 0.51 in Trintelhaven) and daily (R2 = 0.85 in Stavoren, and R2 = 0.43 in Trintelhaven) timescales. These results for the summer periods show that global radiation is not directly coupled to open water evaporation at the hourly or even daily timescale, but rather wind speed and vertical gradient of vapour pressure are variables that explain most of the variance of open water evaporation. However, when we extend the time series to a complete year, we find a distinct yearly cycle reflecting the yearly dynamics of global radiation. We find that the commonly used model of Penman (1948) produces results that resemble the yearly cycle of observed evaporation. However, at the diurnal scale estimated evaporation using Penman's model disagrees with observed evaporation. Therefore, using the Penman equation to model open water evaporation for shorter periods of time is questioned. We would like to stress the importance of including the correct drivers in the parameterization of open water evaporation in hydrological models to adequately represent the role of evaporation in the surfosphere interaction of inland water bodies. [ABSTRACT FROM AUTHOR]

Purpose: Before and after treatment for head and neck cancer (HNC), many patients have problems with mastication, swallowing, and salivary flow. The aim of this study was to investigate the association between objective test outcomes of mastication, swallowing, and salivary flow versus patient-reported outcomes (PROs) measuring mastication-, swallowing-, and salivary flow–related quality of life. Methods: Data of the prospective cohort "Netherlands Quality of Life and Biomedical Cohort Study" was used as collected before treatment, and 3 and 6 months after treatment. Spearman's rho was used to test the association between objective test outcomes of the mixing ability test (MAT) for masticatory performance, the water-swallowing test (WST) for swallowing performance, and the salivary flow test versus PROs (subscales of the EORTC QLQ-H&N35, Swallow Quality of Life questionnaire (SWAL-QoL-NL) and Groningen Radiation-Induced Xerostomia (GRIX)). Results: Data of 142 patients were used, and in total, 285 measurements were performed. No significant correlations were found between the MAT or WST and subscales of the EORTC QLQ-H&N35. Significant but weak correlations were found between the MAT or WST and 4 subscales of the SWAL-QoL-NL. Weak to moderate correlations were found between the salivary flow test and GRIX at 3 and 6 months after treatment, with the highest correlation between salivary flow and xerostomia during the day (Spearman's rho = − 0.441, p = 0.001). Conclusion: The association between objective test outcomes and PROs is weak, indicating that these outcome measures provide different information about masticatory performance, swallowing, and salivary flow in patients with HNC. [ABSTRACT FROM AUTHOR]

Objective: This study systematically reviewed the association of psychological problems among cancer patients with healthcare and societal resource use and costs. Methods: PubMed, PsycINFO, and Embase were searched (until 31 January 2021) for studies on psychological symptoms (anxiety, depression, distress, fear of recurrence) or psychiatric disorders (anxiety, depression, adjustment) and healthcare use (e.g., mental, inpatient healthcare), economic losses by patients and family, economic losses in other sectors (e.g., absence from work), and costs. The search, data extraction, and quality assessment were performed by two authors. Results: Of the 4157 identified records, 49 articles were included (psychological symptoms (n = 34), psychiatric disorders (n = 14), both (n = 1)) which focused on healthcare use (n = 36), economic losses by patients and family (n = 5), economic losses in other sectors (n = 8) and/or costs (n = 13). In total, for 12 of the 94 associations strong evidence was found. Psychological symptoms and psychiatric disorders were positively associated with increased healthcare use (mental, primary, inpatient, outpatient healthcare), losses in other sectors (absence from work), and costs (inpatient, outpatient, total healthcare costs). Moderate evidence was found for a positive association between (any) psychiatric disorder and depression disorder with inpatient healthcare and medication use, respectively. Conclusions: Psychological problems in cancer patients are associated with increased healthcare use, healthcare costs and economic losses. Further research is needed on psychological problems in relation to understudied healthcare use or costs categories, productivity losses, and informal care costs. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this pretest–posttest study was to investigate the reach and effects of My Changed Body (MyCB), an expressive writing activity based on self-compassion, among head and neck cancer (HNC) survivors. Methods: This pilot study had a pretest–posttest design. HNC survivors received an invitation to complete a baseline survey on body image-related distress. At the end of the survey, HNC survivors were asked if they were interested in the intervention study. This entailed the writing activity and a survey 1 week and 1 month post-intervention. The reach was calculated by dividing the number of participants in the intervention study, by the number of (1) eligible HNC survivors and (2) those who filled in the baseline survey. Linear mixed models were used to analyze the effect on body image-related distress. Logistic regression analysis was used to investigate factors associated with the reach and reduced body image-related distress. MyCB was evaluated using study-specific questions. Results: The reach of MyCB was 15–33% (depending on reference group) and was associated with lower education level, more social eating problems, and fewer wound healing problems. Among the 87 participants, 9 (10%) showed a clinically relevant improvement in body image-related distress. No significant effect on body image-related distress was found. Self-compassion improved significantly during follow-up until 1 month post-intervention (p=0.003). Users rated satisfaction with MyCB as 7.2/10. Conclusion: MyCB does not significantly improve body image-related distress, but is likely to increase self-compassion, which sustains for at least 1 month. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the course of health-related quality of life (HRQOL) from diagnosis to 2 years follow-up among patients with oropharyngeal cancer (OPSCC), in relation to human papilloma virus (HPV) status. Methods: This study included 270 OPSCC patients. Age, sex, tumor sublocation, tumor stage, HPV status, treatment modality, comorbidity, smoking, and alcohol use were retrieved from medical records. HPV status was positive when p16 and HPV DNA tests were both positive. HRQOL was assessed using the EORTC QLQ-C30/QLQ-H&N35 pretreatment and at 6 weeks, 6, 12, 18, and 24 months after treatment. To compare the course of HRQOL between patients with an HPV-positive versus HPV-negative tumor, linear and logistic mixed models were used. Results: Patients with an HPV-positive tumor (29%) were more often male, diagnosed with a tumor of the tonsil or base of the tongue, treated with single treatment, had fewer comorbidities, were less often current smokers and had lower alcohol consumption. Adjusted for confounders, the course of global quality of life, physical, role, and social functioning, fatigue, pain, insomnia, and appetite loss was significantly different: patients with an HPV-positive tumor scored better before treatment, worsened during treatment, and recovered better and faster at follow-up, compared to patients with an HPV-negative tumor. The course of emotional functioning and oral pain was also significantly different between the two groups, but with other trajectories. Conclusion: The course of HRQOL is different in patients with an HPV-positive tumor versus an HPV-negative tumor, adjusted for sociodemographic, clinical, and lifestyle confounders. [ABSTRACT FROM AUTHOR]

Purpose: To measure utilities among cancer patients, a cancer-specific utility instrument called the European Organization for Research and Treatment of Cancer (EORTC) QLU-C10D has been developed based on EORTC quality of life core module (QLQ-C30). This study aimed to provide Dutch utility weights for the QLU-C10D. Methods: A cross-sectional valuation study was performed in 1017 participants representative in age and gender of the Dutch general population. The valuation method was a discrete choice experiment containing 960 choice sets, i.e. pairs of QLU-C10D health states, each health state described in terms of the 10 QLU-C10D domains and the duration of that health state. Each participant considered 16 choice sets, choosing their preferred health state from each pair. Utility scores were derived using generalized estimation equation models. Non-monotonic levels were combined. Results: Utility decrements were generated for all 10 QLU-C10D domains, with largest decrements for pain (− 0.242), physical functioning (− 0.228), and role functioning (− 0.149). Non-monotonic levels of emotional functioning, pain, fatigue, sleep problems, and appetite loss were combined. No decrement in utility was seen in case of a little or quite a bit impairment in emotional functioning or a little pain. The mean QLU-C10D utility score of the participants was 0.85 (median = 0.91, interquartile range = 0.82 to 0.96). Conclusion: Dutch utility decrements were generated for the QLU-C10D. These are important for evaluating the cost-utility of new cancer treatments and supportive care interventions. Further insight is warranted into the added value of the QLU-C10D alongside other utility instruments. [ABSTRACT FROM AUTHOR]

Background: Head and neck cancer (HNC) patients often suffer from distress attributed to their cancer diagnosis which may disturb their sleep. However, there is lack of research about poor sleep quality among newly diagnosed HNC patients. Therefore, our aim was to investigate the prevalence and the associated factors of poor sleep quality among HNC patients before starting treatment.Materials and Methods: A cross-sectional study was conducted using the baseline data from NET-QUBIC study, an ongoing multi-center cohort of HNC patients in the Netherlands. Poor sleep quality was defined as a Pittsburgh Sleep Quality Index (PSQI) total score of > 5. Risk factors examined were sociodemographic factors (age, sex, education level, living situation), clinical characteristics (HNC subsite, tumor stage, comorbidity, performance status), lifestyle factors, coping styles, and HNC symptoms.Results: Among 560 HNC patients, 246 (44%) had poor sleep quality before start of treatment. Several factors were found to be significantly associated with poor sleep: younger age (odds ratio [OR] for each additional year 0.98, 95% CI 0.96-1.00), being female (OR 2.6, 95% CI 1.7-4.1), higher passive coping style (OR 1.18, 95% CI 1.09-1.28), more oral pain (OR 1.10, 95% CI 1.01-1.19), and less sexual interest and enjoyment (OR 1.13, 95% CI 1.06-1.20).Conclusion: Poor sleep quality is highly prevalent among HNC patients before start of treatment. Early evaluation and tailored intervention to improve sleep quality are necessary to prepare these patients for HNC treatment and its consequences. [ABSTRACT FROM AUTHOR]

Background: Gliomas are associated with significant healthcare burden, yet reports of costs are scarce. While many costs are unavoidable there may be treatable symptoms contributing to higher costs. We describe healthcare and societal costs in glioma patients at high risk for depression and their family caregivers, and explore relationships between costs and treatable symptoms. Methods: Data from a multicenter randomized trial on effects of internet-based therapy for depressive symptoms were used (NTR3223). Costs of self-reported healthcare utilization, medication use, and productivity loss were calculated for patients and caregivers separately. We used generalized linear regression models to predict costs with depressive symptoms, fatigue, cognitive complaints, tumor grade (low-/high-grade), disease status (stable or active/progression), and intervention (use/non-use) as predictors. Results: Multiple assessments from baseline through 12 months from 91 glioma patients and 46 caregivers were used. Mean overall costs per year were M = €20,587.53 (sd = €30,910.53) for patients and M = €5,581.49 (sd = €13,102.82) for caregivers. In patients, higher healthcare utilization costs were associated with more depressive symptoms; higher medication costs were associated with active/progressive disease. In caregivers, higher overall costs were linked with increased caregiver fatigue, cognitive complaints, and lower patient tumor grade. Higher healthcare utilization costs were related to more cognitive complaints and lower tumor grade. More productivity loss costs were associated with increased fatigue (all P < 0.05). Conclusions: There are substantial healthcare and societal costs for glioma patients and caregivers. Associations between costs and treatable psychological symptoms indicate that possibly, adequate support could decrease costs. Trial registration: Netherlands Trial Register NTR3223. [ABSTRACT FROM AUTHOR]

Accurate monitoring and prediction of surface evaporation become more crucial for adequate water management in a changing climate. Given the distinct differences between characteristics of a land surface and a water body, evaporation from water bodies requires a different parameterization in hydrological models. Here we compare six commonly used evaporation methods that are sensitive to different drivers of evaporation, brought about by a different choice of parameterization. We characterize the (dis)agreement between the methods at various temporal scales ranging from hourly to 10-yearly periods, and we evaluate how this reflects in differences in simulated water losses through evaporation of Lake IJssel in the Netherlands. At smaller timescales the methods correlate less (r=0.72) than at larger timescales (r=0.97). The disagreement at the hourly timescale results in distinct diurnal cycles of simulated evaporation for each method. Although the methods agree more at larger timescales (i.e. yearly and 10-yearly), there are still large differences in the projected evaporation trends, showing a positive trend to a more (i.e. Penman, De Bruin–Keijman, Makkink, and Hargreaves) or lesser extent (i.e. Granger–Hedstrom and FLake). The resulting discrepancy between the methods in simulated water losses of the Lake IJssel region due to evaporation ranges from -4 mm (Granger–Hedstrom) to -94 mm (Penman) between the methods. This difference emphasizes the importance and consequence of the evaporation method selection for water managers in their decision making. [ABSTRACT FROM AUTHOR]

Background: Incurable cancer does not only affect patients, it also affects the lives of their partners. Many partners take on caregiving responsibilities. The burden of these caregiving tasks are often associated with physical, psychological, and social difficulties and many partners have unmet supportive care needs. Oncokompas is an eHealth self-management application to support partners in finding and obtaining optimal supportive care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas.Methods: A total of 136 adult partners of patients with incurable cancer will be included. Partners will be randomly assigned to the intervention group, which directly gets access to Oncokompas, or the waiting-list control group, which gets access to Oncokompas after three months. The primary outcome measure is caregiver burden. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement.Discussion: This study will result in evidence on the efficacy and cost-utility of Oncokompas among partners of patients with incurable cancer, which might lead to implementation of Oncokompas as a health service for partners of patients with incurable cancer.Trial Registration: Netherlands Trial Register, NTR 7636. Registered on 23 November 2018. [ABSTRACT FROM AUTHOR]

Objectives: To investigate among patients treated with a total laryngectomy (TL) (1) Internet-use and Internet use to search for information on health and cancer (content); (2) which patients are most likely to use the Internet in general, for health-related and cancer-related purposes; (3) which other types of eHealth (community, communication, care) are used; and (4) preferences towards future use.Methods: Patient members of the Dutch TL patient society were asked to complete a questionnaire on Internet use, health-related and cancer-related Internet use, types of eHealth, preferences towards future use, socio-demographics, clinical factors, and quality of life (QOL). Factors associated with Internet use and health-related and cancer-related Internet use were investigated using stepwise logistic regression analysis.Results: In total, 279 TL patients participated, of whom 68% used the Internet. Of these, 63% used the Internet to search for information on health and 49% on cancer. Younger and higher educated TL patients and those with better QOL used the Internet more often. Patients with worse QOL searched more often for health-related information. Younger patients and those with shorter time since TL searched more often for cancer-related information. The current use of eHealth for communication, community, and care purposes among Internet users was limited (range, 2 to 15%). Many were interested in using these types of eHealth in the future (range, 21 to 72%).Conclusion: The majority used the Internet, especially to search for information on health and cancer, but only few for communication, community, or care purposes. Many were interested in future use. [ABSTRACT FROM AUTHOR]

Purpose: Stepped care (SC), consisting of watchful waiting, guided self-help, problem-solving therapy, and psychotherapy/medication is, compared to care-as-usual (CAU), effective in improving psychological distress. This study presents secondary analyses on subgroups of patients who might specifically benefit from watchful waiting, guided self-help, or the entire SC program.Methods: In this randomized controlled trial, head and neck and lung cancer patients with distress (n = 156) were randomized to SC or CAU. Univariate logistic regression analyses were performed to investigate baseline factors associated with recovery after watchful waiting and guided self-help. Potential moderators of the effectiveness of SC compared to CAU were investigated using linear mixed models.Results: Patients without a psychiatric disorder, with better psychological outcomes (HADS: all scales) and better health-related quality of life (HRQOL) (EORTC QLQ-C30/H&N35: global QOL, all functioning, and several symptom domains) were more likely to recover after watchful waiting. Patients with better scores on distress, emotional functioning, and dyspnea were more likely to recover after guided self-help. Sex, time since treatment, anxiety or depressive disorder diagnosis, symptoms of anxiety, symptoms of depression, speech problems, and feeling ill at baseline moderated the efficacy of SC compared to CAU.Conclusions: Patients with distress but who are relatively doing well otherwise, benefit most from watchful waiting and guided self-help. The entire SC program is more effective in women, patients in the first year after treatment, patients with a higher level of distress or anxiety or depressive disorder, patients who are feeling ill, and patients with less speech problems.Trial: NTR1868. [ABSTRACT FROM AUTHOR]

Since the 1950s, Europe has undergone large shifts in climate and land cover. Previous assessments of past and future changes in evapotranspiration or streamflow have either focussed on land use/cover or climate contributions or on individual catchments under specific climate conditions, but not on all aspects at larger scales. Here, we aim to understand how decadal changes in climate (e.g. precipitation, temperature) and land use (e.g. deforestation/afforestation, urbanization) have impacted the amount and distribution of water resource availability (both evapotranspiration and streamflow) across Europe since the 1950s. To this end, we simulate the distribution of average evapotranspiration and streamflow at high resolution (1 km 2) by combining (a) a steady-state Budyko model for water balance partitioning constrained by long-term (lysimeter) observations across different land use types, (b) a novel decadal high-resolution historical land use reconstruction, and (c) gridded observations of key meteorological variables. The continental-scale patterns in the simulations agree well with coarser-scale observation-based estimates of evapotranspiration and also with observed changes in streamflow from small basins across Europe. We find that strong shifts in the continental-scale patterns of evapotranspiration and streamflow have occurred between the period around 1960 and 2010. In much of central-western Europe, our results show an increase in evapotranspiration of the order of 5 %–15 % between 1955–1965 and 2005–2015, whereas much of the Scandinavian peninsula shows increases exceeding 15 %. The Iberian Peninsula and other parts of the Mediterranean show a decrease of the order of 5 %–15 %. A similar north–south gradient was found for changes in streamflow, although changes in central-western Europe were generally small. Strong decreases and increases exceeding 45 % were found in parts of the Iberian and Scandinavian peninsulas, respectively. In Sweden, for example, increased precipitation is a larger driver than large-scale reforestation and afforestation, leading to increases in both streamflow and evapotranspiration. In most of the Mediterranean, decreased precipitation combines with increased forest cover and potential evapotranspiration to reduce streamflow. In spite of considerable local- and regional-scale complexity, the response of net actual evapotranspiration to changes in land use, precipitation, and potential evaporation is remarkably uniform across Europe, increasing by ∼ 35–60 km 3 yr -1 , equivalent to the discharge of a large river. For streamflow, effects of changes in precipitation (∼ 95 km 3 yr -1) dominate land use and potential evapotranspiration contributions (∼ 45–60 km 3 yr -1). Locally, increased forest cover, forest stand age, and urbanization have led to significant decreases and increases in available streamflow, even in catchments that are considered to be near-natural. [ABSTRACT FROM AUTHOR]

Accurate monitoring and prediction of surface evaporation becomes more crucial for adequate water management in a changing climate. Given the distinct differences between characteristics of a land surface and a water body, evaporation from water bodies require a different parameterization in hydrological models. Here we compare six commonly used evaporation methods that are sensitive to different drivers of evaporation, brought about by a different choice of parameterization. We characterize the (dis)agreement between the methods at various temporal scales ranging from hourly to 10-yearly periods, and we evaluate how this reflects in differences in simulated water losses through evaporation of lake IJsselmeer in The Netherlands. At smaller timescales the methods correlate less (r = 0.72) than at larger timescales (r = 0.97). The disagreement at the hourly timescale results in distinct diurnal cycles of simulated evaporation for each method. Although the methods agree more at larger timescales (i.e. yearly and 10-yearly), there are still large differences in the projected evaporation trends, showing a positive trend to a more (i.e. Penman, De Bruin-Keijman, Makkink and Hargreaves) or lesser extent (i.e. Granger-Hedstrom and FLake). The resulting discrepancy between the methods in simulated water losses of the IJsselmeer region due to evaporation is ranging from -4 mm (Granger-Hedstrom) to -94 mm (Penman) between the methods. This difference emphasizes the importance and consequence of the evaporation method selection for water managers in their decision making. [ABSTRACT FROM AUTHOR]

Introduction: The EORTC QLQ-CR29 is a patient-reported outcome measure to evaluate health-related quality of life among colorectal cancer patients in research and clinical practice. The aim of this systematic review was to investigate whether the initial positive results regarding the measurement properties of the QLQ-CR29 are confirmed in subsequent studies.Methods: A systematic search of Embase, Medline, PsycINFO, and Web of Science was conducted to identify studies investigating the measurement properties of the QLQ-CR29 published up to January 2019. For the 11 included studies, data were extracted, methodological quality was assessed, results were synthesized, and evidence was graded according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology on the measurement properties: structural validity, internal consistency, reliability, measurement error, construct validity (hypothesis testing, including known-group comparison, convergent and divergent validity), cross-cultural validity, and responsiveness.Results: Internal consistency was rated as "sufficient," with low evidence. Reliability was rated as "insufficient," with moderate evidence. Construct validity (hypothesis testing; known-group comparison, convergent and divergent validity) was rated as "inconsistent," with moderate evidence. Structural validity, measurement error, and responsiveness were rated as "indeterminate" and could therefore not be graded.Conclusion: This review indicates that current evidence supporting the measurement properties of the QLQ-CR29 is limited. Additionally, better quality research is needed, taking into account the COSMIN methodology. [ABSTRACT FROM AUTHOR]

Objective: To systematically review the literature on factors associated with a clinical diagnosis of depression or symptoms of depression (depression) among head and neck cancer (HNC) patients.Methods: The search was conducted in PubMed, PsycINFO, and CINAHL. Studies were included if they investigated factors associated with depression among HNC patients, they were of prospective or longitudinal nature, and English full text was available. The search, data extraction, and quality assessment were performed by two authors. Based on the data extraction and quality assessment, the level of evidence was determined.Results: In total, 35 studies were included: 21 on factors associated with depression at a single (later) time point, 10 on the course of depression, and four on both. In total, 77 sociodemographic, lifestyle, clinical, patient-reported outcome measures, and inflammatory factors were extracted. Regarding depression at a single time point, there was strong evidence that depression at an earlier time point was significantly associated. For all other factors, evidence was inconclusive, although evidence suggests that age, marital status, education, ethnicity, hospital/region, sleep, smoking, alcohol, surgery, treatment, tumor location, and recurrence are not important associated factors. Regarding the course of depression, we found inconclusive evidence for all factors, although evidence suggests that gender, age, chemotherapy, pain, disease stage, treatment, and tumor location are not important associated factors.Conclusion: Depression at an earlier time point is significantly associated with depression later on. Several sociodemographic and clinical factors seem not to be important factors associated with depression. For other factors, further research is warranted. [ABSTRACT FROM AUTHOR]

Since the 1950s, Europe has seen large shifts in climate and land cover. Previous assessments of past and future changes in evapotranspiration or streamflow have either focussed on land use/cover or climate contributions, or have focussed on individual catchments under specific climate conditions. Here, we aim to understand how decadal changes in climate (e.g., precipitation, temperature) and land use (e.g., de-/afforestation, urbanization) have impacted the amount and distribution of water resources availability across Europe since the 1950s. To this end, we simulate the distribution of green and blue water fluxes at high-resolution (1 × 1 km) by combining (a) a steady-state Budyko model for water balance partitioning constrained by long-term (lysimeter) observations across different land-use types, (b) a novel decadal high-resolution historical land use reconstruction, and (c) gridded observations of key meteorological variables. The continental-scale patterns in the simulations agree well with coarser-scale observation-based estimates of evapotranspiration, and also with observed changes in streamflow from small basins across Europe. We find that strong shifts in the continental-scale patterns of evapotranspiration and streamflow have occured from 1950 to 2010. In Sweden, for example, increased precipitation dominates effects of large scale re- and afforestation leading to increases in both streamflow and evapotranspiration. In most of the Mediterrenean, decreased precipitation combines with increased forest cover and potential evapotranspiration to reduce streamflow. In spite of local and regional scale complexity, the Europe-wide net contribution of land use, precipitation and potential evapotranspiration changes to changes in ET is similar with around ~ 40 km³/y, equivalent to the discharge of a large river. For streamflow, changes in precipitation dominate land use and potential evapotranspiration contributions with ~ 90 km³/y compared to ~ 45 km³/y. Locally, increased forest cover and urbanisation have lead to significant decreases and increases of available streamflow. [ABSTRACT FROM AUTHOR]

Background: The purpose of this study was to investigate unmet supportive care needs in patients treated with total laryngectomy and its associated factors. Methods: In this cross‐sectional study, 283 patients who underwent total laryngectomy completed questions on supportive care needs (Supportive Care Needs Survey [SCNS]). Median time since total laryngectomy surgery was 7 years (range 0‐37 years). The prevalence of unmet supportive care needs and its associated factors were investigated using logistic regression analyses. Results: Unmet supportive care needs were highest for the head and neck cancer‐specific functioning domain (53%), followed by the psychological (39%), physical and daily living (37%), health system, information, and patient support (35%), sexuality (23%), and lifestyle (5%) domains. Seventy‐one percent reported at least one low, moderate, or high unmet need. Female sex, living alone, and having a voice prosthesis were positively associated with unmet needs on 1 domain (P <.05). A worse health‐related quality of life was associated with unmet needs on all domains. Conclusion: The majority of patients who underwent total laryngectomy report at least one low, moderate, or high unmet supportive care need. [ABSTRACT FROM AUTHOR]

A correction to the article "The course of swallowing problems in the first 2 years after diagnosis of head and neck cancer" is presented which appeared in the previous issue of the periodical.

Objective: The objective of the study is to investigate the relation between pretreatment depressive symptoms (DS) and the course of DS during the first year after cancer diagnosis, and overall survival among people with head and neck cancer (HNC).Methods: Data from the Head and Neck 5000 prospective clinical cohort study were used. Depressive symptoms were measured using the Hospital Anxiety and Depression Scale (HADS) pretreatment, at 4 and 12-month follow-up. Also, socio-demographic, clinical, lifestyle, and mortality data were collected. The association between before start of treatment DS (HADS-depression > 7) and course (never DS, recovered from DS, or persistent/recurrent/late DS at 12-month follow-up) and survival was investigated using Cox regression. Unadjusted and adjusted analyses were performed.Results: In total, 384 of the 2144 persons (18%) reported pretreatment DS. Regarding DS course, 63% never had DS, 16% recovered, and 20% had persistent/recurrent/late DS. People with pretreatment DS had a higher risk of earlier death than people without DS (hazard ratio (HR) = 1.65; 95% confidence interval (CI) 1.33-2.05), but this decreased after correcting for socio-demographic, clinical, and lifestyle-related factors (HR = 1.21; 95% CI 0.97-1.52). Regarding the course of DS, people with persistent/recurrent/late DS had a higher risk of earlier death (HR = 2.04; 95% CI 1.36-3.05), while people who recovered had a comparable risk (HR = 1.12; 95% CI 0.66-1.90) as the reference group who never experienced DS. After correcting for socio-demographic and clinical factors, people with persistent/recurrent/late DS still had a higher risk of earlier death (HR = 1.66; 95% CI 1.09-2.53).Conclusions: Pretreatment DS and persistent/recurrent/late DS were associated with worse survival among people with HNC. [ABSTRACT FROM AUTHOR]

Purpose: The EORTC IN-PATSAT32 is a patient-reported outcome measure (PROM) to assess cancer patients' satisfaction with in-patient health care. The aim of this study was to investigate whether the initial good measurement properties of the IN-PATSAT32 are confirmed in new studies.Methods: Within the scope of a larger systematic review study (Prospero ID 42017057237), a systematic search was performed of Embase, Medline, PsycINFO, and Web of Science for studies that investigated measurement properties of the IN-PATSAT32 up to July 2017. Study quality was assessed, data were extracted, and synthesized according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology.Results: Nine studies were included in this review. The evidence on reliability and construct validity were rated as sufficient and of the quality of the evidence as moderate. The evidence on structural validity was rated as insufficient and of low quality. The evidence on internal consistency was indeterminate. Measurement error, responsiveness, criterion validity, and cross-cultural validity were not reported in the included studies. Measurement error could be calculated for two studies and was judged indeterminate.Conclusion: In summary, the IN-PATSAT32 performs as expected with respect to reliability and construct validity. No firm conclusions can be made yet whether the IN-PATSAT32 also performs as well with respect to structural validity and internal consistency. Further research on these measurement properties of the PROM is therefore needed as well as on measurement error, responsiveness, criterion validity, and cross-cultural validity. For future studies, it is recommended to take the COSMIN methodology into account. [ABSTRACT FROM AUTHOR]

Background: Meaning-centered group psychotherapy for cancer survivors (MCGP-CS) improves meaning, psychological well-being, and mental adjustment to cancer and reduces psychological distress. This randomized controlled trial was conducted to investigate the cost-utility of MCGP-CS compared with supportive group psychotherapy (SGP) and care-as-usual (CAU).Methods: In total, 170 patients were randomized to MCGP-CS, SGP, or CAU. Intervention costs, direct medical and nonmedical costs, productivity losses, and health-related quality of life were measured until 6 months follow-up, using the TIC-P, PRODISQ, data from the hospital information system, and the EQ-5D. The cost-utility was calculated by comparing mean cumulative costs and quality-adjusted life years (QALYs).Results: Mean total costs ranged from €4492 (MCGP-CS) to €5304 (CAU). Mean QALYs ranged .507 (CAU) to .540 (MCGP-CS). MCGP-CS had a probability of 74% to be both less costly and more effective than CAU, and 49% compared with SGP. Sensitivity analyses showed these findings are robust. If society is willing to pay €0 for one gained QALY, MCGP-CS has a 78% probability of being cost-effective compared with CAU. This increases to 85% and 92% at willingness-to-pay thresholds of €10 000 and €30 000, which are commonly accepted thresholds.Conclusions: MCGP-CS is highly likely a cost-effective intervention, meaning that there is a positive balance between the costs and gains of MCGP-CS, in comparison with SGP and CAU. [ABSTRACT FROM AUTHOR]

Introduction: Body image is acknowledged as an important aspect of health-related quality of life in cancer patients. The Body Image Scale (BIS) is a patient-reported outcome measure (PROM) to evaluate body image in cancer patients. The aim of this study was to systematically review measurement properties of the BIS among cancer patients.Methods: A search in Embase, MEDLINE, PsycINFO, and Web of Science was performed to identify studies that investigated measurement properties of the BIS (Prospero ID 42017057237). Study quality was assessed (excellent, good, fair, poor), and data were extracted and analyzed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology on structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, and responsiveness. Evidence was categorized into sufficient, insufficient, inconsistent, or indeterminate.Results: Nine studies were included. Evidence was sufficient for structural validity (one factor solution), internal consistency (α = 0.86-0.96), and reliability (r > 0.70); indeterminate for measurement error (information on minimal important change lacked) and responsiveness (increasing body image disturbance in only one study); and inconsistent for hypothesis testing (conflicting results). Quality of the evidence was moderate to low. No studies reported on cross-cultural validity.Conclusion: The BIS is a PROM with good structural validity, internal consistency, and test-retest reliability, but good quality studies on the other measurement properties are needed to optimize evidence. It is recommended to include a wider variety of cancer diagnoses and treatment modalities in these future studies. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study is to investigate the associations between patient activation and total costs in cancer patients treated with total laryngectomy (TL).Methods: All members of the Dutch Patients' Association for Laryngectomees were asked to participate in this cross-sectional study. TL patients who wanted to participate were asked to complete a survey. Costs were measured using the medical consumption and productivity cost questionnaire and patient activation using the Patient Activation Measure (PAM). Sociodemographic and clinical characteristics were self-reported, and health status measured using the EQ-5D. The difference in total costs from a healthcare and societal perspective among four groups with different PAM levels were compared using (multiple) regression analyses (5000 bootstrap replications).Results: In total, 248 TL patients participated. Patients with a higher (better) PAM (levels 2, 3, and 4) had a probability of 70, 80, and 93% that total costs from a healthcare perspective were lower than in patients with the lowest PAM level (difference €-375 to €-936). From a societal perspective, this was 73, 87, and 82% (difference €-468 to €-719). After adjustment for time since TL, education, and sex, the probability that total costs were lower in patients with a higher PAM level compared to patients with the lowest PAM level changed to 62-91% (healthcare) and 63-92% (societal). After additional adjustment for health status, the probability to be less costly changed to 35-71% (healthcare) and 31-48% (societal).Conclusions: A better patient activation is likely to be associated with lower total costs from a healthcare and societal perspective. [ABSTRACT FROM AUTHOR]

Background: Cancer survivors have to deal with a wide range of physical symptoms, psychological, social and existential concerns, and lifestyle issues related to cancer and its treatment. Therefore, it is essential that they have access to optimal supportive care services. The eHealth self-management application Oncokompas was developed to support cancer survivors with where they need to turn to for advice and guidance, as well as to increase their knowledge on the availability of optimal support. A randomised controlled trial will be conducted to assess the efficacy, cost-utility and reach of Oncokompas as an eHealth self-management application compared with care as usual among cancer survivors.Methods/design: Adult cancer survivors diagnosed with breast, colorectal or head and neck cancer or lymphoma who are at 3 months to 5 years since curative treatment will be included. In total, 544 cancer survivors will be randomly assigned to the intervention group or a wait-list control group. The primary outcome measure is patient activation. Secondary outcome measures include self-efficacy, personal control, perceived patient-physician interaction, need for supportive care, mental adjustment to cancer and health-related quality of life. Furthermore, cost-utility outcomes will be assessed. Reach is defined as the percentage of cancer survivors who get access to Oncokompas within the context of this trial. Questionnaires will be administered at baseline, post-intervention and at 3- and 6-month follow-up.Discussion: In this study, we will evaluate the efficacy and cost-utility of Oncokompas among cancer survivors, as well as the reach of Oncokompas. These are essential first steps in the translation of research into practice and contribute to sustainable adoption, implementation and maintenance of an evidence-based Oncokompas.Trial Registration: Netherlands Trial Register identifier: NTR5774 . Registered on 8 March 2016. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study is to assess the psychometric properties of the Dutch version of the 34-item Short-Form Supportive Care Needs Survey (SCNS-SF34) and the newly developed module for head and neck cancer (HNC) patients (SCNS-HNC).Methods: HNC patients were included from two cross-sectional studies. Content validity of the SCNS-HNC was analysed by examining redundancy and completeness of items. Factor structure was assessed using confirmatory and exploratory factor analyses. Cronbach's alpha, Spearman's correlation, Mann-Whitney U test, Kruskall-Wallis and intraclass correlation coefficients (ICC) were used to assess internal consistency, construct validity and test-retest reliability.Results: Content validity of the SCNS-HNC was good, although some HNC topics were missing. For the SCNS-SF34, a four-factor structure was found, namely physical and daily living, psychological, sexuality and health system and information and patient support (alpha = .79 to .95). For the SCNS-HNC, a two-factor structure was found, namely HNC-specific functioning and lifestyle (alpha = .89 and .60). Respectively, 96 and 89 % of the hypothesised correlations between the SCNS-SF34 or SCNS-HNC and other patient-reported outcome measures were found; 57 and 67 % also showed the hypothesised magnitude of correlation. The SCNS-SF34 domains discriminated between treatment procedure (physical and daily living p = .02 and psychological p = .01) and time since treatment (health system, information and patient support p = .02). Test-retest reliability of SCNS-SF34 domains and HNC-specific functioning domain was above .70 (ICC = .74 to .83), and ICC = .67 for the lifestyle domain. Floor effects ranged from 21.1 to 70.9 %.Conclusions: The SCNS-SF34 and SCNS-HNC are valid and reliable instruments to evaluate the need for supportive care among (Dutch) HNC patients. [ABSTRACT FROM AUTHOR]

Background: Total laryngectomy with or without adjuvant (chemo)radiation often induces speech, swallowing and neck and shoulder problems. Speech, swallowing and shoulder exercises may prevent or diminish these problems. The aim of the present paper is to describe the study, which is designed to investigate the effectiveness and cost-utility of a guided self-help exercise program built into the application "In Tune without Cords" among patients treated with total laryngectomy.Methods/design: Patients, up to 5 years earlier treated with total laryngectomy with or without (chemo)radiation will be recruited for participation in this study. Patients willing to participate will be randomized to the intervention or control group (1:1). Patients in the intervention group will be provided access to a guided self-help exercise program and a self-care education program built into the application "In Tune without Cords". Patients in the control group will only be provided access to the self-care education program. The primary outcome is the difference in swallowing quality (SWAL-QOL) between the intervention and control group. Secondary outcome measures address speech problems (SHI), shoulder disability (SDQ), quality of life (EORTC QLQ-C30, QLQ-H&N35 and EQ-5D), direct and indirect costs (adjusted iMCQ and iPCQ measures) and self-management (PAM). Patients will be asked to complete these outcome measures at baseline, immediately after the intervention or control period (i.e. at 3 months follow-up) and at 6 months follow-up.Discussion: This randomized controlled trial will provide knowledge on the effectiveness of a guided self-help exercise program for patients treated with total laryngectomy. In addition, information on the value for money of such an exercise program will be provided. If this guided self-help program is (cost)effective for patients treated with total laryngectomy, the next step will be to implement this exercise program in current clinical practice.Trial Registration: NTR5255 Protocol version 4 date September 2015. [ABSTRACT FROM AUTHOR]