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Contains fulltext : 306351.pdf (Publisher’s version ) (Open Access)

01 april 2023, Item does not contain fulltext, AIMS AND OBJECTIVES: The self-performance of a Five-Times-Sit-To-Stand (FTSTS)-test, without the usual supervision by a medical professional, provides valuable opportunities for clinical practice and research. This study aimed: (1) to determine the validity of the self-performed FTSTS test in comparison to a supervised reference test and (2) to determine the reliability of a self-performed FTSTS test by cancer survivors. BACKGROUND: Early detection of frailty in cancer survivors may enable prehabilitation interventions before surgery or intensive treatment, improving cancer outcomes. DESIGN: A repeated measures reliability and agreement study, with one week in between measures, was performed. METHODS: Cancer survivors (n = 151) performed two FTSTS tests themselves. One additional reference FTSTS test was supervised by a physical therapist. The intraclass correlation coefficient (ICC), structural error of measurement (SEM) and minimally important clinical difference (MID) were calculated comparing a self-performed FTSTS test to the reference test, and comparing two self-performed FTSTS tests. The Guidelines for Reporting Reliability and Agreement Studies (GRASS) have been used. RESULTS: Mean age of cancer survivors was 65.6 years (SD = 9.3), 54.6% were female, median time since diagnosis was 2 years [IQR = 1], and tumour type varied (e.g., breast cancer (31.8%), prostate cancer (17.2%), gastrointestinal cancer (11.9%) and haematological cancer (11.9%)). Validity of the self-performed FTSTS test at home was acceptable in comparison with the reference test (ICC = .74; SEM = 3.2; MID = 3.6) as was the reliability of the self-performed FTSTS test (ICC = .70; SEM = 2.2; MID = 3.8). CONCLUSIONS: The self-performed FTSTS test is a valid and reliable measure to assess lower body function and has potential to be used as objective (pre-)screening tool for frailty in cancer survivors. RELEVANCE TO CLINICAL PRACTICE: The self-performed FTSTS test at home may indicate the cancer

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01 juni 2023, Item does not contain fulltext, PURPOSE: To examine the effects and moderators of exercise effects on cardiometabolic outcomes in men with prostate cancer previously or currently undergoing androgen deprivation therapy (ADT). RESULTS: Seven trials including 560 patients were examined. Exercise resulted in significant effects on whole-body and regional fat mass (P ≤ 0.001). For whole-body fat mass, significant exercise effects were observed in patients who were unmarried (-1.4 kg, P < 0.05) and who presented with higher fat mass levels (-1.0 kg, P < 0.05). For diastolic blood pressure and low-density lipoprotein (LDL), younger (-4.7 mmHg, P < 0.05) and older patients (-0.2 mmol.l(-1), P < 0.10) achieved greater effects, respectively. Regarding high-density lipoprotein (HDL), patients undertaking ADT + prostatectomy + radiotherapy derived significant exercise effects (0.3 mmol.l(-1), P < 0.05). CONCLUSIONS: Exercise effectively reduces fat mass across subgroups of men undergoing or following ADT with different characteristics. For diastolic blood pressure, HDL and LDL, groups based on age and treatment history could be specifically targeted with exercise medicine.

Radboud University, 04 juli 2023, Promotores : Hopman, M.T.E., Vliet, J.J. van der Co-promotores : Buffart, L.M., Stuiver, M.M., Contains fulltext : 293832.pdf (Publisher’s version ) (Closed access)

01 juni 2023, Item does not contain fulltext, INTRODUCTION: Older men with prostate cancer are commonly affected by reductions in lean mass and physical function following androgen deprivation therapy (ADT). Resistance-based exercise programs are critical to counteract the musculoskeletal toxicities derived from prostate cancer treatment and aging. However, there is significant variability in the effects of exercise interventions. Examining demographic and clinical moderators of exercise effects in this patient group can assist in identifying which subgroups of patients benefit most. Therefore, we examined the effects and moderators of resistance-based exercise programs on sarcopenia-related outcomes that included lean mass, skeletal muscle index, physical function, and muscle strength in older men with prostate cancer. MATERIALS AND METHODS: Data were retrieved from the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) consortium. For the present study, we included data from trials that examined the effects of supervised resistance-based exercise interventions on lean mass outcomes, muscle strength, and physical function in patients with prostate cancer previously or currently treated with ADT. Linear mixed models were undertaken to analyse the effects of resistance-based exercise programs considering the clustering of patients within studies. Effects were evaluated by regressing the study group on the post-intervention value of the outcome adjusted for the baseline value, while potential moderators were examined by adding the moderator and its interaction term into the regression model. RESULTS: A total of 560 patients with prostate cancer (age: 69.5 ± 7.8 yrs.; body mass index: 28.6 ± 4.0 kg.m(-2)) previously or currently treated with ADT were included. Resistance-based exercise programs resulted in significant effects on whole-body and appendicular lean mass and the skeletal muscle index (P < 0.05), with improvements observed across different characteristics. Improvements were also obse

Item does not contain fulltext, BACKGROUND: The emerging study of wearable devices (WDs) in patients with cancer provides opportunities to harness real-time patient data for predicting clinical outcomes. We conducted a systematic review with best evidence synthesis to examine the association between WD metrics and clinical outcomes in patients with cancer. METHODS: MEDLINE and Embase were searched from inception until June 2022. Risk of bias assessment and best evidence synthesis were performed and, If possible, meta-analysis was conducted. RESULTS: A total of 34 studies was included. We found moderate-to-strong evidence for associations between circadian rest-activity metrics and OS. Disrupted I

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Contains fulltext : 294870.pdf (Publisher’s version ) (Open Access), 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.

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Contains fulltext : 299963.pdf (Publisher’s version ) (Closed access), PURPOSE: Growing recognition of the gut microbiome as an influential modulator of cancer treatment efficacy and toxicity has led to the emergence of clinical interventions targeting the microbiome to enhance cancer and health outcomes. The highly modifiable nature of microbiota to endogenous, exogenous, and environmental inputs enables interventions to promote resilience of the gut microbiome that have rapid effects on host health, or response to cancer treatment. While diet, probiotics, and faecal microbiota transplant are primary avenues of therapy focused on restoring or protecting gut function in people undergoing cancer treatment, the role of physical activity and exercise has scarcely been examined in this population. METHODS: A narrative review was conducted to explore the nexus between cancer care and the gut microbiome in the context of physical activity and exercise as a widely available and clinically effective supportive care strategy used by cancer survivors. RESULTS: Exercise can facilitate a more diverse gut microbiome and functional metabolome in humans; however, most physical activity and exercise studies have been conducted in healthy or athletic populations, primarily using aerobic exercise modalities. A scarcity of exercise and microbiome studies in cancer exists. CONCLUSIONS: Exercise remains an attractive avenue to promote microbiome health in cancer survivors. Future research should elucidate the various influences of exercise modalities, intensities, frequencies, durations, and volumes to explore dose-response relationships between exercise and the gut microbiome among cancer survivors, as well as multifaceted approaches (such as diet and probiotics), and examine the influences of exercise on the gut microbiome and associated symptom burden prior to, during, and following cancer treatment.

Item does not contain fulltext, BACKGROUND: Maintaining a sufficient health-related quality of life (HRQoL) is important in the palliative treatment of patients with metastatic colorectal cancer (mCRC). The ORCHESTRA trial (ClinicalTrials.gov identifier: NCT01792934) is designed to prospectively evaluate overall survival benefit and impact on HRQoL of tumor debulking when added to first-line palliative systemic therapy in patients with multiorgan mCRC. In the present study, we report the HRQoL associated with this combination treatment compared with standard systemic therapy. METHODS: Patients included in the ORCHESTRA trial with clinical benefit after 3 or 4 cycles of first-line palliative systemic therapy with fluoropyrimidines and oxaliplatin with or without bevacizumab were randomly assigned to maximal tumor debulking followed by systemic therapy versus systemic therapy alone. Patients completed the EORTC Quality of Life Questionnaire-Core 30 and the Multidimensional Fatigue Inventory questionnaire at prespecified time points during treatment. Between-group differences in HRQoL over time were evaluated with linear mixed model analyses. A pattern mixture approach was applied to correct for missing questionnaires due to progressive disease. RESULTS: A total of 300 patients were randomized to the intervention arm (n=148) or the standard arm (n=152). No statistically significant or clinically relevant differences in HRQoL and fatigue were observed when tumor debulking was added to systemic therapy. In patients of both study arms, HRQoL after 1 year of treatment was not significantly different from HRQoL at the time of randomization. Patients in the intervention arm experienced serious adverse events (SAEs) twice as often as patients in the standard arm (P≤.001). CONCLUSIONS: Maximal tumor debulking in combination with palliative systemic therapy in patients with multiorgan mCRC was significantly associated with more SAEs resulting from local therapy but no difference in HRQoL compared with palliat

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Contains fulltext : 246509.pdf (Publisher’s version ) (Open Access)

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Item does not contain fulltext, OBJECTIVE: Non-adherence to adjuvant endocrine therapy (AET) for breast cancer leads to increased recurrence and mortality risk and healthcare costs. Evidence on feasible, effective AET adherence interventions is scarce. This paper describes the systematic adaptation of the cost-effective adherence improving self-management strategy (AIMS) for patients with HIV to AET for women after breast cancer treatment. METHODS: We followed the intervention mapping protocol for adapting interventions by conducting a needs assessment, reviewing target behaviours and determinants, reassessing behaviour change methods and adapting programme content. Therefore, we performed a literature review, consulted behavioural theory and organised nine advisory board meetings with patients and healthcare professionals. RESULTS: Non-adherence occurs frequently among AET users. Compared to HIV treatment, AET is less effective, and AET side effects are more burdensome. This drives AET treatment discontinuation. However, the key determinants of non-adherence are largely similar to HIV treatment (e.g. motivation, self-regulation and patient-provider relationship); therefore, most strategies in AIMS-HIV also seem suitable for AIMS-AET. Modifications were required, however, regarding supporting patients with coping with side effects and sustaining treatment motivation. CONCLUSION: AIMS seems to be a suitable framework for adherence self-management across conditions and treatments. Intervention mapping offered a transparent, systematic approach to adapting AIMS-HIV to AET.

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Contains fulltext : 283463.pdf (Publisher’s version ) (Open Access), BACKGROUND: There is much evidence to implement physical activity interventions for medical reasons in healthcare settings. However, the prescription of physical activity as a treatment, referring to as 'Exercise is Medicine' (E = M) is currently mostly absent in routine hospital care in The Netherlands. To support E = M prescription by clinicians in hospitals, this study aimed: (1) to develop an E = M-tool for physical activity advice and referrals to facilitate the E = M prescription in hospital settings; and (2) to provide an E = M decision guide on key decisions for implementation to prepare for E = M prescription in hospital care. METHODS: A mixed method design was used employing a questionnaire and face-to-face interviews with clinicians, lifestyle coaches and hospital managers, a patient panel and stakeholders to assess the needs regarding an E = M-tool and key decisions for implementation of E = M. Based on the needs assessment, a digital E = M-tool was developed. The key decisions informed the development of an E = M decision guide. RESULTS: An online supportive tool for E = M was developed for two academic hospitals. Based on the needs assessment, linked to the different patients' electronic medical records and tailored to the two local settings (University Medical Center Groningen, Amsterdam University Medical Centers). The E = M-tool existed of a tool algorithm, including patient characteristics assessed with a digital questionnaire (age, gender, PA, BMI, medical diagnosis, motivation to change physical activity and preference to discuss physical activity with their doctor) set against norm values. The digital E = M-tool provided an individual E = M-prescription for patients and referral options to local PA interventions in- and outside the hospital. An E = M decision guide was developed to support the implementation of E = M prescription in hospital care. CONCLUSIONS: This study provided insight into E = M-tool development and the E = M decision-making

01 juni 2022, Contains fulltext : 251716.pdf (Publisher’s version ) (Open Access), OBJECTIVE: This study examined experiences, adherence and satisfaction with a combined exercise and dietary intervention in patients with ovarian cancer and their healthcare professionals (HCPs) as part of the randomized PADOVA trial. METHODS: A mixed-methods approach was used in 24 patients with ovarian cancer receiving first-line chemotherapy who were randomly allocated to a combined exercise and dietary intervention or usual care with counseling sessions post-treatment. Qualitative data on intervention experiences, adherence and satisfaction was collected using semi-structured interviews with patients and their HCPs (n = 18 physical therapists; n = 5 dietitians). Quantitative data on adherence and satisfaction was collected to provide context to qualitative data. RESULTS: Exercise relative dose intensity ranged from 36 to 100% (median 72%) and patients attended 33-133% (median 100%) of the prescribed dietary counseling sessions. Patients appreciated guidance on exercise and nutrition and perceived benefits including improved physical fitness, quality of life, peer support and recovery after surgery and/or chemotherapy cycles. Both patients and HCPs were satisfied with the intervention and perceived that participation exceeded prior expectations. Median patient satisfaction score with the intervention was 8.5 out of 10. Suggestions for improving the intervention included further personalization of the number, content and scheduling of the sessions to preferences of patients and HCPs. Patients in the usual care group reported counseling sessions post-chemotherapy to be too little too late. CONCLUSIONS: Patients with ovarian cancer adhered well to the intervention. Numerous perceived benefits of the intervention were reported by patients and HCPs. Good adherence and positive experiences support successful implementation in clinical practice.

Contains fulltext : 253189.pdf (Publisher’s version ) (Open Access)

Contains fulltext : 283460.pdf (Publisher’s version ) (Open Access), INTRODUCTION: The results from the physical training and cancer randomized controlled trial (Phys-Can RCT) indicate that high intensity (HI) strength and endurance training during (neo-)adjuvant cancer treatment is more beneficial for cardiorespiratory fitness (CRF, measured as peak oxygen uptake [VO(2)peak]) than low-to-moderate intensity (LMI) exercise. Adherence to the exercise intervention and demographic or clinical characteristics of patients with breast cancer undergoing adjuvant treatment may moderate the exercise intervention effect on VO(2)peak. In this study, the objective was to investigate whether baseline values of VO(2)peak, body mass index (BMI), time spent in moderate- to vigorous-intensity physical activity (MVPA), physical fatigue, age, chemotherapy treatment, and the adherence to the endurance training moderated the effect of HI vs. LMI exercise on VO(2)peak. MATERIALS AND METHODS: We used data collected from a subsample from the Phys-Can RCT; women who were diagnosed with breast cancer and had a valid baseline and post-intervention VO(2)peak test were included (n = 255). The exercise interventions from the RCT included strength and endurance training at either LMI, which was continuous endurance training at 40-50% of heart rate reserve (HRR), or at HI, which was interval training at 80-90% of HRR, with similar exercise volume in the two groups. Linear regression analyses were used to investigate moderating effects using a significance level of p < 0.10. Statistically significant interactions were examined further using the Johnson-Neyman (J-N) technique and regions of significance (for continuous variables) or box plots with adjusted means of post-intervention VO(2)peak (for binary variables). RESULTS: Age, as a continuous variable, and adherence, dichotomized into < or > 58% based on median, moderated the effect of HI vs. LMI on CRF (B = -0.08, 95% CI [-0.16, 0.01], p (interaction) = 0.06, and B = 1.63, 95% CI [-0.12, 3.38], p (interaction) = 0

Background This systematic review and meta-analysis synthesized evidence in patients with ovarian cancer at diagnosis and/or during first-line treatment on; (i) the association of body weight, body composition, diet, exercise, sedentary behavior, or physical fitness with clinical outcomes; and (ii) the effect of exercise and/or dietary interventions. Methods Risk of bias assessments and best-evidence syntheses were completed. Meta-analyses were performed when ≥3 papers presented point estimates and variability measures of associations or effects. Results Body mass index (BMI) at diagnosis was not significantly associated with survival. Although the following trends were not supported by the best-evidence syntheses, the meta-analyses revealed that a higher BMI was associated with a higher risk of post-surgical complications (n = 5, HR: 1.63, 95% CI: 1.06–2.51, p = 0.030), a higher muscle mass was associated with a better progression-free survival (n = 3, HR: 1.41, 95% CI: 1.04–1.91, p = 0.030) and a higher muscle density was associated with a better overall survival (n = 3, HR: 2.12, 95% CI: 1.62–2.79, p < 0.001). Muscle measures were not significantly associated with surgical or chemotherapy-related outcomes. Conclusions The prognostic value of baseline BMI for clinical outcomes is limited, but muscle mass and density may have more prognostic potential. High-quality studies with comprehensive reporting of results are required to improve our understanding of the prognostic value of body composition measures for clinical outcomes. Systematic review registration number: PROSPERO identifier CRD42020163058.

01 december 2021, Contains fulltext : 244864.pdf (Publisher’s version ) (Open Access), BACKGROUND: A uniform treatment strategy for patients suffering from early recurrence after local treatment of CRLM is currently lacking. The aim of this observational cohort study was to assess the potential survival benefit of repeat local treatment compared to systemic therapy in patients suffering from early recurrence of CRLM. PATIENTS AND METHODS: Patients who developed recurrent CRLM within 12 months after initial local treatment with curative intent were retrospectively identified in Amsterdam University Medical Centers between 2009-2019. Differences in overall and progression-free survival among treatment strategies were assessed using multivariable Cox regression analyses. RESULTS: A total of 135 patients were included. Median overall survival of 41 months [range 4-135] was observed in patients who received repeat local treatment, consisting of upfront or repeat local treatment after neoadjuvant systemic therapy, compared to 24 months [range 1-55] in patients subjected to systemic therapy alone (adjusted HR = 0.42 [95%-CI: 0.25-0.72]; P = .002). Prolonged progression-free survival was observed after neoadjuvant systemic therapy followed by repeat local treatment, as compared to upfront repeat local treatment in patients with recurrent CRLM within 4 months following initial local treatment of CRLM (adjusted HR = 0.36 [95%-CI: 0.15-0.86]; P = .021). CONCLUSION: Patients with early recurrence of CRLM should be considered for repeat local treatment strategies. A multimodality approach, consisting of neoadjuvant systemic therapy followed by repeat local treatment, appeared favorable in patients with recurrence within 4 months following initial local treatment of CRLM.

Item does not contain fulltext, BACKGROUND: Patients, who discontinue early, do not benefit from phase I/II clinical trials (early-phase clinical trials (EPCT)). In this study, associations between objective smartphone measurements of physical activity and fitness and early trial discontinuation in patients with cancer participating in EPCT were investigated. METHODS: Before start of treatment, physical activity (steps/day) and physical fitness (meters walked in 6 min) were measured with a smartphone, and patient-reported physical function (PRO-PF) was assessed (EORTC QLQ-C30-PF). Early trial discontinuation was defined as discontinuation ≤ 28 days. Univariable logistic regression analyses were performed to study associations of physical activity, fitness, and function with early trial discontinuation. Optimal cutoff values of physical activity and fitness were assessed with ROCs, based on positive predictive values (PPV). RESULTS: Median (interquartile range (IQR)) step count was 4263 (2548-6897) steps/day, mean ± standard deviation 6-min walking distance was 477 ± 120 m and median (IQR) PRO-PF score was 83 (67-95) points. Fourteen patients (12%) discontinued the trial early. Smartphone measurements of physical activity in units of 100 steps per day (odds ratio (OR) = 0.96, 95% CI = 0.94-0.99, p = 0.01), physical fitness (OR = 0.99, 95% CI = 0.98-0.99, p < 0.01), and PRO-PF (OR = 0.97, 95% CI = 0.94-1.00, p = 0.03) were associated with early trial discontinuation. Optimal cutoff values were < 900 steps for physical activity and < 285 m for physical fitness. PPV for early trial discontinuation was 100% in patients who walked both < 1500 steps per day and < 300 m in 6 min. CONCLUSIONS: Objective smartphone measurements of physical activity and fitness are associated with early trial discontinuation. However, cutoff values should be externally validated in a larger cohort before implementation in clinical practice.

Item does not contain fulltext, Exercise during cancer treatment improves cancer-related fatigue (CRF), but the importance of exercise intensity for CRF is unclear. We compared the effects of high- vs low-to-moderate-intensity exercise with or without additional behavior change support (BCS) on CRF in patients undergoing (neo-)adjuvant cancer treatment. This was a multicenter, 2x2 factorial design randomized controlled trial (Clinical Trials NCT02473003) in Sweden. Participants recently diagnosed with breast (n = 457), prostate (n = 97) or colorectal (n = 23) cancer undergoing (neo-)adjuvant treatment were randomized to high intensity (n = 144), low-to-moderate intensity (n = 144), high intensity with BCS (n = 144) or low-to-moderate intensity with BCS (n = 145). The 6-month exercise intervention included supervised resistance training and home-based endurance training. CRF was assessed by Multidimensional Fatigue Inventory (MFI, five subscales score range 4-20), and Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F, score range 0-52). Multiple linear regression for main factorial effects was performed according to intention-to-treat, with post-intervention CRF as primary endpoint. Overall, 577 participants (mean age 58.7 years) were randomized. Participants randomized to high- vs low-to-moderate-intensity exercise had lower physical fatigue (MFI Physical Fatigue subscale; mean difference -1.05 [95% CI: -1.85, -0.25]), but the difference was not clinically important (ie <2). We found no differences in other CRF dimensions and no effect of additional BCS. There were few minor adverse events. For CRF, patients undergoing (neo-)adjuvant treatment for breast, prostate or colorectal cancer can safely exercise at high- or low-to-moderate intensity, according to their own preferences. Additional BCS does not provide extra benefit for CRF in supervised, well-controlled exercise interventions.

01 april 2021, Contains fulltext : 238780.pdf (Publisher’s version ) (Open Access), PURPOSE: We aimed to examine whether pre-treatment, post-treatment and change in health-related quality of Life (HRQoL) is associated with survival, in patients with head and neck cancer (HNC). METHODS: We included 948 newly diagnosed HNC patients treated with primary or adjuvant (chemo)radiotherapy with curative intent. The EORTC QLQ-C30 questionnaire was assessed pre-treatment and at 6 weeks, 6 months and 12 months post-treatment. Multivariable Cox regression analyses were performed to examine whether HRQoL at all time points and changes in HRQoL over time were associated with survival, after adjusting for demographic, clinical and lifestyle-related variables. RESULTS: Higher HRQoL scores were significantly associated with improved 5-year overall survival at all time points, except for the subscale global QoL at 6 weeks. Changes in HRQoL at 6 weeks post-treatment compared to pre-treatment were not significantly associated with survival. Changes in physical (HR: 0.88 95% CI: 0.82-0.96) and emotional functioning (HR: 0.90 95% CI: 0.85-0.96) from pre-treatment to 6 months post-treatment and changes in global QOL, and physical, emotional, and social functioning from pre-treatment to 12 months post-treatment were significantly associated with survival. CONCLUSION: Higher HRQoL reported pre-treatment and post-treatment (6 weeks, 6 months and 12 months) are significantly associated with improved survival, as well as changes in HRQoL at 6 and 12 months compared to pre-treatment. Our results highlight the value of monitoring HRQoL and to identify those patients that report decreased or deteriorated HRQOL. This may help to further improve cancer care in a timely and efficient manner.

Item does not contain fulltext, STUDY DESIGN: Individual participant data (IPD) meta-analysis. OBJECTIVE: The aim of this study was to identify which participant characteristics moderate the effect of spinal manipulative therapy (SMT) on pain and functioning in chronic LBP. SUMMARY OF BACKGROUND: The effects of SMT are comparable to other interventions recommended in guidelines for chronic low back pain (LBP); however, it is unclear which patients are more likely to benefit from SMT compared to other therapies. METHODS: IPD were requested from randomized controlled trials (RCTs) examining the effect of SMT in adults with chronic LBP for pain and function compared to various other therapies (stratified by comparison). Potential patient moderators (n = 23) were a priori based on their clinical relevance. We investigated each moderator using a one-stage approach with IPD and investigated this interaction with the intervention for each time point (1, 3, 6, and 12 months). RESULTS: We received IPD from 21 of 46 RCTs (n = 4223). The majority (12 RCTs, n = 2249) compared SMT to recommended interventions. The duration of LBP, baseline pain (confirmatory), smoking, and previous exposure to SMT (exploratory) had a small moderating effect across outcomes and follow-up points; these estimates did not represent minimally relevant differences in effects; for example, patients with <1 year of LBP demonstrated more positive point estimates for SMT versus recommended therapy for the outcome pain (mean differences ranged from 4.97 (95% confidence interval, CI: -3.20 to 13.13) at 3 months, 10.76 (95% CI: 1.06 to 20.47) at 6 months to 5.26 (95% CI: -2.92 to 13.44) at 12 months in patients with over a year LBP. No other moderators demonstrated a consistent pattern across time and outcomes. Few moderator analyses were conducted for the other comparisons because of too few data. CONCLUSION: We did not identify any moderators that enable clinicians to identify which patients are likely to benefit more from SMT compared t

Contains fulltext : 235264.pdf (Publisher’s version ) (Open Access), Despite stringent eligibility criteria for trial participation, early discontinuation often occurs in phase I trials. To better identify patients unlikely to benefit from phase I trials, we investigated predictors for early trial discontinuation. Data from 415 patients with solid tumors who participated in 66 trials were pooled for the current analysis. Early trial discontinuation was defined as (i) trial discontinuation within 28 days after start of treatment or (ii) discontinuation before administration of the first dosage in eligible patients. Multilevel logistic regression analyses were conducted to identify predictors for early trial discontinuation. Eighty-two participants (20%) demonstrated early trial discontinuation. Baseline sodium level below the lower limit of normal (OR = 2.95, 95%CI = 1.27-6.84), elevated alkaline phosphatase level > 2.5 times the upper limit of normal (OR = 2.72, 95%CI = 1.49-4.99), performance score ≥ 1 (OR = 2.07, 95%CI = 1.03-4.19) and opioid use (OR = 1.82, 95%CI = 1.07-3.08) were independent predictors for early trial discontinuation. Almost 50% of the patients with hyponatremia and all four patients in whom all four predictors were present together discontinued the trial early. Hyponatremia, elevated alkaline phosphatase level, performance score ≥ 1 and opioid use were identified as significant predictors for early trial discontinuation. Hyponatremia was the strongest predictor and deserves consideration for inclusion in eligibility criteria for future trials.

Contains fulltext : 235002.pdf (Publisher’s version ) (Open Access)

01 september 2021, Item does not contain fulltext, BACKGROUND: A 2019 review concluded that spinal manipulative therapy (SMT) results in similar benefit compared to other interventions for chronic low back pain (LBP). Compared to traditional aggregate analyses individual participant data (IPD) meta-analyses allows for a more precise estimate of the treatment effect. PURPOSE: To assess the effect of SMT on pain and function for chronic LBP in a IPD meta-analysis. DATA SOURCES: Electronic databases from 2000 until April 2016, and reference lists of eligible trials and related reviews. STUDY SELECTION: Randomized controlled trials (RCT) examining the effect of SMT in adults with chronic LBP compared to any comparator. DATA EXTRACTION AND DATA SYNTHESIS: We contacted authors from eligible trials. Two review authors independently conducted the study selection and risk of bias. We used GRADE to assess the quality of the evidence. A one-stage mixed model analysis was conducted. Negative point estimates of the mean difference (MD) or standardized mean difference (SMD) favors SMT. RESULTS: Of the 42 RCTs fulfilling the inclusion criteria, we obtained IPD from 21 (n=4223). Most trials (s=12, n=2249) compared SMT to recommended interventions. There is moderate quality evidence that SMT vs recommended interventions resulted in similar outcomes on pain (MD -3.0, 95%CI: -6.9 to 0.9, 10 trials, 1922 participants) and functional status at one month (SMD: -0.2, 95% CI -0.4 to 0.0, 10 trials, 1939 participants). Effects at other follow-up measurements were similar. Results for other comparisons (SMT vs non-recommended interventions; SMT as adjuvant therapy; mobilization vs manipulation) showed similar findings. SMT vs sham SMT analysis was not performed, because we only had data from one study. Sensitivity analyses confirmed these findings. LIMITATIONS: Only 50% of the eligible trials were included. CONCLUSIONS: Sufficient evidence suggest that SMT provides similar outcomes to recommended interventions, for pain relief and improvemen

Contains fulltext : 235507.pdf (Publisher’s version ) (Open Access)

Contains fulltext : 244770.pdf (Publisher’s version ) (Open Access), Renal function-based carboplatin dosing using measured glomerular filtration rate (GFR) results in more consistent drug exposure than anthropometric dosing. We aimed to validate the Newell dosing equation using estimated GFR (eGFR) and study which equation most accurately predicts carboplatin clearance in children with retinoblastoma. In 13 children with retinoblastoma 38 carboplatin clearance values were obtained from individual fits using MWPharm++. Carboplatin exposure (AUC) was calculated from administered dose and observed carboplatin clearance and compared to predicted AUC calculated with a carboplatin dosing equation (Newell) using different GFR estimates. Different dosing regimens were compared in terms of accuracy, bias and precision. All patients had normal eGFR. Carboplatin exposure using cystatin C-based eGFR equations tended to be more accurate compared to creatinine-based eGFR (30% accuracy 76.3-89.5% versus 76.3-78.9%, respectively), which led to significant overexposure, especially in younger (aged ≤ 2 years) children. Of all equations, the Schwartz cystatin C-based equation had the highest accuracy and lowest bias. Although anthropometric dosing performed comparably to many of the eGFR equations overall, we observed a weight-dependent change in bias leading to underdosing in the smallest patients. Using cystatin C-based eGFR equations for carboplatin dosing in children leads to more accurate carboplatin-exposure in patients with normal renal function compared to anthropometric dosing. In children with impaired kidney function, this trend might be more pronounced. Anthropometric dosing is hampered by a weight-dependent bias.

01 november 2021, Contains fulltext : 238833.pdf (Publisher’s version ) (Open Access), PURPOSE: The expanding armamentarium of wearable activity monitors (WAMs) offers new opportunities to supplement physician-assessed performance status (PS) with real-life patient activity data. These data could guide clinical decision making or serve as a measure of treatment outcome. However, information on the association between physical activity (PA) and sedentary behavior (SB) monitored with wearables (i.e., WAM metrics) and PS in patients with cancer is needed. Therefore, we conducted a systematic review to examine the association between WAM metrics and PS in patients with cancer. METHODS: We searched MEDLINE and Embase for studies that assessed the association between WAM metrics and performance status among adults with cancer. We extracted information on study design and population, WAM type and different activity metrics, outcome definitions, and results. Included studies were subjected to risk of bias assessment and subsequent best evidence synthesis. RESULTS: Fourteen studies were included in this review. All studies reported on different combinations of WAM metrics including: daily steps (n = 8), SB (n = 5), mean activity counts (n = 4), dichotomous circadian rest-activity index (n = 3), and time spent in moderate-to-vigorous PA (MVPA) (n = 3). Much heterogeneity was observed regarding study population, WAM used, and reporting of results. We found moderate evidence for a positive weak-to-moderate association between WAM-assessed PA and PS and a weak-to-moderate negative association between WAM-assessed SB metrics and PS. CONCLUSION: Weak-to-moderate associations between WAM metrics and PS suggest that WAM data and physician-assessed PS cannot be used interchangeably. Instead, WAM data could serve as a dynamic and objective supplement measurement of patients' physical performance.

Contains fulltext : 225951.pdf (Publisher’s version ) (Closed access), PURPOSE: This study evaluated the effects of coping skills training (CST) on symptoms of depression and anxiety in cancer patients, and investigated moderators of the effects. METHODS: Overall effects and intervention-related moderators were studied in meta-analyses of pooled aggregate data from 38 randomized controlled trials (RCTs). Patient-related moderators were examined using linear mixed-effect models with interaction tests on pooled individual patient data (n = 1953) from 15 of the RCTs. RESULTS: CST had a statistically significant but small effect on depression (g = -0.31,95% confidence interval (CI) = -0.40;-0.22) and anxiety (g = -0.32,95%CI = -0.41;-0.24) symptoms. Effects on depression symptoms were significantly larger for interventions delivered face-to-face (p = .003), led by a psychologist (p = .02) and targeted to patients with psychological distress (p = .002). Significantly larger reductions in anxiety symptoms were found in younger patients (p(interaction) < 0.025), with the largest reductions in patients <50 years (β = -0.31,95%CI = -0.44;-0.18) and no significant effects in patients ≥70 years. Effects of CST on depression (β = -0.16,95%CI = -0.25;-0.07) and anxiety (β = -0.24,95%CI = -0.33;-0.14) symptoms were significant in patients who received chemotherapy but not in patients who did not (p(interaction) < 0.05). CONCLUSIONS: CST significantly reduced symptoms of depression and anxiety in cancer patients, and particularly when delivered face-to-face, provided by a psychologist, targeted to patients with psychological distress, and given to patients who were younger and received chemotherapy.

Contains fulltext : 229302.pdf (publisher's version ) (Open Access), INTRODUCTION: As a consequence of ovarian cancer and its treatment, many women with ovarian cancer have to deal with reduced physical function, fatigue, and loss of weight and/or muscle mass, compromising quality of life. Exercise and dietary interventions can positively influence body composition, physical fitness and function, and fatigue in patients with cancer. However, there are no data from randomised controlled trials on the effectiveness of exercise and dietary interventions in patients with ovarian cancer. Due to a complex disease trajectory, a relatively poor survival and distinct disease-induced and treatment-induced side effects, it is unclear whether exercise and dietary interventions that were shown to be feasible and effective in other types of cancer produce comparable results in patients with ovarian cancer. The aim of this article is to present the design of the multicentre randomised controlled Physical Activity and Dietary intervention in OVArian cancer trial and to describe how the exercise and dietary intervention is tailored to specific comorbidities and disease-induced and treatment-induced adverse effects in patients with ovarian cancer. METHODS AND ANALYSIS: Adult women with primary epithelial ovarian cancer who are scheduled to undergo first-line (neo)adjuvant chemotherapy (n=122) are randomly allocated to a combined exercise and dietary intervention or a usual care control group during chemotherapy. Primary outcomes are body composition, physical function and fatigue. Outcome measures will be assessed before the start of chemotherapy, 3 weeks after completion of chemotherapy and 12 weeks later. The exercise and dietary intervention was tailored to ovarian cancer-specific comorbidities and adverse effects of ovarian cancer and its treatment following the i3-S strategy. ETHICS AND DISSEMINATION: This study has been approved by the medical ethical committee of the Amsterdam UMC (reference: 018). Results of the study will be published in inte

Contains fulltext : 229883.pdf (publisher's version ) (Open Access), BACKGROUND: The prescription of physical activity (PA) in clinical care has been advocated worldwide. This "exercise is medicine" (E=M) concept can be used to prevent, manage, and cure various lifestyle-related chronic diseases. Due to several challenges, E=M is not yet routinely implemented in clinical care. OBJECTIVE: This paper describes the rationale and design of the Physicians Implement Exercise = Medicine (PIE=M) study, which aims to facilitate the implementation of E=M in hospital care. METHODS: PIE=M consists of 3 interrelated work packages. First, levels and determinants of PA in different patient and healthy populations will be investigated using existing cohort data. The current implementation status, facilitators, and barriers of E=M will also be investigated using a mixed-methods approach among clinicians of participating departments from 2 diverse university medical centers (both located in a city, but one serving an urban population and one serving a more rural population). Implementation strategies will be connected to these barriers and facilitators using a systematic implementation mapping approach. Second, a generic E=M tool will be developed that will provide tailored PA prescription and referral. Requirements for this tool will be investigated among clinicians and department managers. The tool will be developed using an iterative design process in which all stakeholders reflect on the design of the E=M tool. Third, we will pilot-implement the set of implementation strategies, including the E=M tool, to test its feasibility in routine care of clinicians in these 2 university medical centers. An extensive learning process evaluation will be performed among clinicians, department managers, lifestyle coaches, and patients using a mixed-methods design based on the RE-AIM framework. RESULTS: This project was approved and funded by the Dutch grant provider ZonMW in April 2018. The project started in September 2018 and continues until December 2020 (de

1 februari 2020, Contains fulltext : 220982.pdf (Publisher’s version ) (Closed access), OBJECTIVES: We aimed to investigate accelerometer output corresponding to physical activity intensity cut-points based on percentage of peak oxygen consumption (%VO2peak) and Metabolic Equivalent of Task (MET) value in women treated for breast cancer. DESIGN: Laboratory study. METHODS: Fifty female patients shortly after completion of treatment for breast cancer were included. VO2peak was determined during a cardiopulmonary exercise test. Subsequently, patients performed ten activities with different intensities while wearing an accelerometer on the right hip and a mobile oxycon to assess oxygen consumption. We studied the relationship between energy expenditure (expressed as %VO2peak and MET-value) and accelerometer output (in counts per minute (cpm)) with linear regression analyses. We determined accelerometer output corresponding to physical activity intensity cut-points (40% and 60%VO2peak; 3 and 6 MET) using regression equations. RESULTS: VO2peak was 22.4mL/kg/min (SD 5.2) and resting metabolic rate was 3.1mL/kg/min (SD 0.6). Accelerometer output corresponding to the cut-points for moderate (40% VO2peak) and vigorous intensity (60% VO2peak) were 1123 and 1911, respectively. The analyses based on MET-values resulted in accelerometer output of 1189cpm for the moderate (3 MET) and 2768 cpm for the vigorous intensity cut-point (6 MET). CONCLUSIONS: Accelerometer outputs for moderate and vigorous intensity physical activity were lower than commonly used cut-points (i.e. 1952 and 5724 cpm), irrespective of the method used to express energy expenditure (%VO2peak versus MET-value). Thus, categorizing physical activity intensities based on general-population cut-points, may underestimate physical activity intensities for women treated for breast cancer.

Contains fulltext : 219836.pdf (Publisher’s version ) (Open Access), Introduction: Objective measurements of levels of physical activity and fitness in patients with head and neck cancer (HNC) are lacking. Furthermore, demographic, clinical and lifestyle-related correlates of low levels of physical activity and fitness in patients with HNC are unknown. This study aims to investigate the levels of accelerometer that assessed physical activity and fitness in patients with HNC and to identify their demographical, clinical and lifestyle-related correlates.Methods: Two hundred and fifty-four patients who were recently diagnosed with HNC and participated in the NETherlands QUality of life and Biomedical cohort studies In head and neck Cancer (NET-QUBIC) study were included. Physical activity (accelerometer), cardiorespiratory fitness (Chester Step Test), hand grip strength (hand dynamometer) and lower body muscle function (30-second chair-stand test) were assessed. Multivariable linear regression analyses with a stepwise forward selection procedure were used.Results: Patients spent 229 min/d in physical activity of which 18 min/d in moderate-to-vigorous physical activity. The mean predicted VO2max was 27.9 ml/kg/min, the mean hand grip strength was 38.1 kg and the mean number of standings was 14.3. Patients with lower educational level, more comorbidity and higher tumor stage spent significantly less time in physical activity. Older patients, females and patients with a higher tumor stage had significantly lower cardiorespiratory fitness levels. Older patients, females, patients with more comorbidity, patients with normal weight and patients who have never smoked had significantly lower hand grip strength. Older patients, patients with lower educational level, smokers and patients with more comorbidity had a significantly lower function of lower body muscle.Conclusions: Pre-treatment levels of physical activity, cardiorespiratory fitness and lower body muscle function are low in patients with HNC. Based on this study, exercise programs tar

Item does not contain fulltext, PURPOSE: In this study, we investigated factors associated with program adherence and patient satisfaction with a home-based physical activity program (Onco-Move, N = 77) and a supervised exercise program with a home-based component (OnTrack, N = 76). METHODS: We assessed adherence via self-report (home-based program) and attendance records (supervised program). We used logistic regression analysis to identify sociodemographic, clinical and behavioural variables associated with program adherence. Patient satisfaction was assessed with self-report and is reported descriptively. RESULTS: Fifty-one percent of Onco-Move and 62% of OnTrack participants were adherent to the home-based program, while 59% of OnTrack participants were adherent to the supervised sessions. Higher baseline physical fitness was associated with higher adherence to home-based components. Higher disease stage and having a partner were associated with adherence to OnTrack supervised sessions. Overall satisfaction with the exercise programs was high, but ratings of coaching provided by professionals for the home-based components were low. Patients offered suggestions for improving delivery of the programs. CONCLUSIONS: These findings point to factors relevant to program adherence and suggest ways in which such programs can be improved. Providing additional time and training for health care professionals could improve the quality and hopefully the effectiveness of the interventions. The use of online diaries and smartphone apps may provide additional encouragement to participants. Finally, allowing greater flexibility in the planning and availability of supervised exercise training in order to accommodate the variability in cancer treatment schedules and the (acute) side effects of the treatments could also enhance program adherence. TRIAL REGISTRATION: Netherlands Trial Register, NTR2159. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2159.

01 februari 2020, Contains fulltext : 220990.pdf (Publisher’s version ) (Closed access), PURPOSE: Fatigue is a common and potentially disabling symptom in patients with cancer. It can often be effectively reduced by exercise. Yet, effects of exercise interventions might differ across subgroups. We conducted a meta-analysis using individual patient data of randomized controlled trials (RCT) to investigate moderators of exercise intervention effects on cancer-related fatigue. METHODS: We used individual patient data from 31 exercise RCT worldwide, representing 4366 patients, of whom 3846 had complete fatigue data. We performed a one-step individual patient data meta-analysis, using linear mixed-effect models to analyze the effects of exercise interventions on fatigue (z score) and to identify demographic, clinical, intervention- and exercise-related moderators. Models were adjusted for baseline fatigue and included a random intercept on study level to account for clustering of patients within studies. We identified potential moderators by testing their interaction with group allocation, using a likelihood ratio test. RESULTS: Exercise interventions had statistically significant beneficial effects on fatigue (beta = -0.17; 95% confidence interval [CI], -0.22 to -0.12). There was no evidence of moderation by demographic or clinical characteristics. Supervised exercise interventions had significantly larger effects on fatigue than unsupervised exercise interventions (betadifference = -0.18; 95% CI -0.28 to -0.08). Supervised interventions with a duration

Contains fulltext : 229899.pdf (Publisher’s version ) (Open Access), BACKGROUND: This pilot trial explores the feasibility of measuring muscle contractile properties in patients with cancer, effects of exercise during chemotherapy on muscle contractile properties and the association between changes in contractile muscle properties and perceived fatigue. METHOD: Patients who received (neo)adjuvant chemotherapy for breast or colon cancer were randomized to a 9-12 week exercise intervention or a waitlist-control group. At baseline and follow-up, we measured knee extensor strength using maximal voluntary contraction (MVC), contractile muscle properties of the quadriceps muscle using electrical stimulation, and perceived fatigue using the Multidimensional Fatigue Inventory. Feasibility was assessed by the proportion of patients who successfully completed measurements of contractile muscle properties. Exercise effects on muscle contractile properties were explored using linear regression analyses. Between-group differences >10% were considered potentially relevant. Pearson correlation (r(p) ) of changes in contractile muscle properties and changes in perceived fatigue was calculated. RESULTS: Twenty two of 30 patients completed baseline and follow-up assessments. Measurements of contractile properties were feasible except for muscle fatigability. We found a potentially relevant between-group difference in the rate of force development favoring the intervention group (1192 N/s, 95% CI = -335; 2739). Change in rate of force development was negatively correlated with change in perceived general (r(p) = -0.54, P = .04) and physical (r(p) = -0.59, P = .02) fatigue. CONCLUSION: Chemotherapy induces a decrease in the rate of force development, which may reflect a larger loss in type II muscle fibers. This may be attenuated with (resistance) exercise. The increase in the rate of force development was related to a decrease in perceived fatigue.

Introduction As a consequence of ovarian cancer and its treatment, many women with ovarian cancer have to deal with reduced physical function, fatigue, and loss of weight and/or muscle mass, compromising quality of life. Exercise and dietary interventions can positively influence body composition, physical fitness and function, and fatigue in patients with cancer. However, there are no data from randomised controlled trials on the effectiveness of exercise and dietary interventions in patients with ovarian cancer. Due to a complex disease trajectory, a relatively poor survival and distinct disease-induced and treatment-induced side effects, it is unclear whether exercise and dietary interventions that were shown to be feasible and effective in other types of cancer produce comparable results in patients with ovarian cancer. The aim of this article is to present the design of the multicentre randomised controlled Physical Activity and Dietary intervention in OVArian cancer trial and to describe how the exercise and dietary intervention is tailored to specific comorbidities and disease-induced and treatment-induced adverse effects in patients with ovarian cancer. Methods and analysis Adult women with primary epithelial ovarian cancer who are scheduled to undergo first-line (neo)adjuvant chemotherapy (n=122) are randomly allocated to a combined exercise and dietary intervention or a usual care control group during chemotherapy. Primary outcomes are body composition, physical function and fatigue. Outcome measures will be assessed before the start of chemotherapy, 3 weeks after completion of chemotherapy and 12 weeks later. The exercise and dietary intervention was tailored to ovarian cancer-specific comorbidities and adverse effects of ovarian cancer and its treatment following the i3-S strategy. Ethics and dissemination This study has been approved by the medical ethical committee of the Amsterdam UMC (reference: 018). Results of the study will be published in interna

Contains fulltext : 207407.pdf (publisher's version ) (Closed access), BACKGROUND: Previous systematic reviews and meta-analyses demonstrated beneficial effects of exercise during or following cancer treatment on quality of life (QoL). Aiming to understand how exercise contributes to a patient's QoL, we examined patients' perspectives via a process called concept mapping. This unique method provides structure and objectivity to rich qualitative data. METHODS: Patients with cancer who were participating in an exercise program were invited to enroll. Eleven meetings with 3-10 patients were organized in which patients generated ideas in response to the question "How has participating in a supervised exercise program contributed positively to your QoL?" Next, patients individually clustered (based on similarity) and rated (based on importance) the ideas online. The online assessments were combined, and one concept map was created, visualizing clusters of ideas of how patients perceive that participating in a supervised exercise program improved their QoL. The research team labelled the clusters of ideas, and physiotherapists reflected on the clusters during semistructured interviews. RESULTS: Sixty patients attended the meetings; of these, one patient was not able to generate an idea in response to the statement. Forty-four patients completed the online clustering and rating of ideas. The resulting concept map yielded six clusters: personalized care, coaching by a physiotherapist, social environment, self-concept, coping, and physical fitness and health. Personalized care was rated as most important. Overall, physiotherapists recognized these clusters in practice. CONCLUSION: Patients with cancer reported that participating in a supervised exercise program improved their physical fitness and influenced social, mental, and cognitive factors, resulting in improvements in QoL. These results can be used to increase the awareness of the importance of supervised exercise programs for the QoL of patients with cancer. IMPLICATIONS FOR PRACTICE: Ac