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Purpose: This study compared a tablet PC questionnaire with a paper method for reliability and patient preferences in the acquisition of patient-reported outcomes (PROs) for patients treated with radiotherapy. By comparing the two modes of PRO administration, we aimed to evaluate the adequacy of using tablet PC questionnaires in future clinical use.Methods: Patients were randomized in a crossover study design using two different methods for PRO entry. A group of 89 patients answered a paper questionnaire followed by the tablet PC version, whereas 89 patients in another group completed the tablet PC questionnaire followed by the paper version. Surveys were performed four times per patient throughout the course of the radiotherapy. The Korean versions of the M.D. Anderson Symptom Inventory (MDASI-K) and the Brief Fatigue Inventory (BFI-K) were used. The primary endpoint of our current study was an assessment of patient preference for the survey method. The proportions of patients preferring each mode of questionnaire were evaluated.Results: The proportion of patients who preferred the tablet PC version, paper form, or who had no preference was 52.2, 22.1, and 25.7 %, respectively. More than half of the patients preferred the tablet PC to the paper version in all four surveys. Age, gender, educational status, prior experience of using a tablet PC, and the order of paper to tablet PC administration did not impact patient preferences. Inter-class correlation coefficients (ICCs) between the modes were 0.92 for MDASI-K and 0.94 for BFI-K and ranged from 0.91 to 0.96 on both instruments during the four surveys.Conclusions: A tablet PC-based PRO is an acceptable and reliable method compared with paper-based data collection for Korean patients receiving radiotherapy. [ABSTRACT FROM AUTHOR]

Purpose: Patients with head and neck cancer (HNC) describe eating as more than a physical activity for nutrition and calories. After treatment for HNC, patients report a changed social experience around food, with eating and drinking in front of family and friends depicted as a challenge. However, there is limited research exploring how patients with HNC adapt and cope with social eating difficulties. This study aims to explore patients' experiences and perceptions of social eating and drinking following treatment for HNC.Methods: A qualitative research design using semi-structured interviews was employed to understand the experiences of social eating of patients living with and beyond HNC. Reflexive thematic analysis was used to inductively develop key themes from the data.Results: Fourteen interviews were conducted with patients, and two key themes were identified: (1) "Social eating became a conscious process" and (2) "Strategies to maximise social eating participation". To maximise social eating enjoyment, patients attempted to minimise the attention on their eating function and the fuss created around food. Patients with HNC established psychological and cognitive adaptations to manage expectations and promote positive participation in social eating.Conclusion: This paper identifies key barriers limiting or diminishing social eating for patients with HNC; including being self-conscious, lack of understanding from others and functional issues with eating and drinking. This research highlights the need to raise awareness of social eating challenges and for the social dimensions of eating to be addressed through family-centred, supportive holistic interventions implemented early in the patient's cancer journey. [ABSTRACT FROM AUTHOR]

Purpose: This paper responds to the call for more research to fully understand out of pocket (OOP) costs for cancer patients by providing a detailed discussion of such costs for adult haematology patients from Queensland, Australia.Methods: The descriptive qualitative research was based on in-depth interviews with 45 (n = 45) haematology patients from regional, rural and remote areas.Results: The discussion itemises the OOP costs under four categories including the costs associated with travel and accommodation, the costs associated with family and friends during relocation, the costs associated with diagnosis and treatment, and the costs of parking.Conclusions: The paper provides evidence of the categories of financial burden experienced by haematology patients who have to relocate for specialist treatment by detailing the extensive range of OOP costs. The expectation is that the itemisation of OOP cost variables will contribute to future efforts of quantification. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this paper is to describe a model of palliative rehabilitation for newly diagnosed advanced cancer patients and present data on how it was utilised during a randomised controlled trial (RCT).Methods: We designed a highly flexible, multidisciplinary model of palliative rehabilitation consisting of a "basic offer" and tailored elements. The model was evaluated in the setting on an RCT investigating the effect of systematic referral to a palliative rehabilitation clinic concurrently with standard oncology treatment or standard treatment alone. The basic offer of palliative rehabilitation was two consultations and a 12-week possibility of contacting a palliative rehabilitation team, if needed. In addition, patients and family caregivers could be offered participation in a 12-week patient/caregiver school combined with individually tailored physical exercise in groups, individual consultations, or both. Contacts with the palliative rehabilitation team and participant evaluation were registered prospectively.Results: Between December 2014 and December 2017, 132 adults with newly diagnosed advanced cancer were seen in the palliative rehabilitation outpatient clinic. Twenty percent of the participants received the basic offer only (n = 26), 45% additionally participated in the group program (n = 59), and 35% received supplementary individual consultations without participating in the group program (n = 47). The intervention was primarily led by nurses, and the main themes of the individual consultations were coping, pain, and nutrition. When asked if they would recommend the intervention to others in the same situation, 93% of the respondents agreed, 7% partly agreed, and no one disagreed.Conclusion: The new model of palliative rehabilitation presented here had a flexibility to meet the needs of the participants and led to a very high degree of patient satisfaction. It could serve as an inspiration to other cancer centres wanting to integrate palliative care into standard oncology services. [ABSTRACT FROM AUTHOR]

Purpose: Measure Yourself Concerns and Wellbeing (MYCaW) is a validated person-centred measure of the concerns and wellbeing of people affected by cancer. Research suggests that the concerns of informal caregivers (ICs) are as complex and severely rated as people with cancer, yet MYCaW has only been used to represent cancer patients' concerns and wellbeing. This paper reports on the development of a new qualitative coding framework for MYCaW to capture the concerns of ICs, to better understand the needs of this group.Methods: This multicentred study involved collection of data from ICs receiving support from two UK cancer support charities (Penny Brohn UK and Cavendish Cancer Care). Qualitative codes were developed through a detailed thematic analysis of ICs' stated concerns.Results: Thematic analysis of IC questionnaire data identified key themes which were translated into a coding framework with two overarching sections; (1) 'informal caregiver concerns for self' and (2) 'informal caregiver concerns for the person with cancer'. Supercategories with specific accompanying codes were developed for each section. Two further rounds of framework testing across different cohorts allowed for iterative development and refinement of the framework content.Conclusions: This is the first person-centred tool specifically designed for capturing IC's concerns through their own words. This coding framework will allow for IC data to be analysed using a rigorous and reproducible method, and therefore reported in a standardised way. This may also be of interest to those exploring the needs of ICs of people in other situations. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this paper is to report the results of a negative randomized controlled trial, which piloted brief supportive-expressive therapy (SET) for partners of men with prostate cancer, and to discuss lessons learned for future clinical trials.Methods: Partners of men with newly diagnosed, non-metastatic prostate cancer were randomized to SET (n = 45) or usual care (n = 32). SET involved six weekly group sessions emphasizing emotional expression, social support, and finding meaning in the cancer experience. Measures of mood disturbance, marital satisfaction, and social support were administered to both partners and patients at baseline, post-program, and at 3- and 6-month follow-up.Results: There were no significant differences between SET and the control group for either patients or their wives on any outcome. Regardless of group membership, partners reported improvements in total mood disturbance (p = .011), tension (p < .001), anger (p = .041), confusion (p < .001), state anxiety (p = .001), and emotional support (p = .037), and patients reported improvements in tension (p = .003), emotional support (p = .047), positive interaction support (p = .004), and overall social support (p = .026).Conclusions: Compared to the natural course of recovery, SET did not improve psychosocial outcomes for either men with prostate cancer or their wives. Methodological challenges experienced in implementing this trial yield valuable lessons for future research, including designing interventions relevant to unique problems faced by specific groups, being closely guided by previous research, and the potential utility of screening for distress as an inclusion criteria in intervention trials. [ABSTRACT FROM AUTHOR]

Purpose: Antiemetic guideline recommendations are inconsistent as to whether a neurokinin-1 receptor antagonist (NK1 RA) should be administered with a 5-hydroxytryptamine-3 (5HT3) RA + dexamethasone (DEX) in patients receiving carboplatin. Patients receiving cisplatin routinely receive an NK1 RA-containing regimen with a resulting 14-22 % benefit in no emesis rates over a 5-HT3 RA/DEX control. Recent studies suggest a similar benefit in patients receiving carboplatin. NEPA is the first fixed antiemetic combination agent and comprises the highly selective NK1 RA, netupitant, and pharmacologically distinct 5-HT3 RA, palonosetron (PALO). This paper presents the efficacy of NEPA in the subset of patients receiving carboplatin in a phase 3 trial (NCT01376297), in the context of aprepitant (APR) data in the carboplatin setting.Methods: One hundred ninety-six patients (47 % of all study patients: n = 145 NEPA + DEX; n = 51 APR + PALO + DEX) received carboplatin in a multinational, double-blind, randomized phase 3 study. Complete response (CR: no emesis/rescue) and no significant nausea (NSN: score ≤25 on 100 mm visual analog scale) rates were calculated.Results: Cycle 1-4 overall (0-120 h) CR rates were similar for NEPA (80, 91, 92, and 93 %) and APR (82, 88, 88, and 90 %). Overall NSN rates were also similar (NEPA 84-96 %; APR 82-90 %).Conclusions: Response rates for NEPA and APR regimens were similar and consistent with prior studies evaluating the contribution of adding NK1 RAs in patients receiving carboplatin. Considering such evidence, guideline groups/practitioners should consider giving a NK1 RA antiemetic triplet in patients receiving carboplatin. [ABSTRACT FROM AUTHOR]

Bone marrow transplantation (BMT) has evolved over the last decade from a controversial research procedure to a standard therapeutic modality, becoming an important innovative treatment for hematological malignancies, solid tumors, immunodeficiency diseases and metabolic disorders. Historically in research and clinical literature, the BMT procedure is divided into several stages, each accompanied by particular emotional tones and psychological issues. In providing care for transplant recipients, donors, and families, caregivers must be familiar with the psychological stages of the procedure, the psychological themes such as body image, and the patient's mechanisms of coping with the stress of such protocols. BMT's complex regimens of high-dose chemotherapy and total-body irradiation, germ-free environments, graft-versus-host disease, and total parenteral nutrition can precipitate significant psychological sequelae in some patients with acute and long-term consequences. In response to their illness, transplant patients may also develop emotional disturbances of anxiety, depression, agitation, and non-compliance. This paper will address the psychological care of the patient, donor and family from pre-BMT consultation, through informed consent, hospitalization and convalescence. Various psychotherapeutic, pharmacological and behavioral interventions will be briefly described. Finally, areas of research in quality of life after BMT and factors that may predict BMT adjustment and outcome will be explored. We hope this brief paper will familiarize the reader with this psychologically intriguing field and will provide a departure point for future reading, study, research, and patient/family care. [ABSTRACT FROM AUTHOR]

Purpose: This study evaluated the efficacy of a self-guided Web-based cognitive behaviour therapy (CBT) intervention compared to an attention control in improving cancer-related distress, health-related quality of life (HRQOL), and maladaptive coping, among people recently diagnosed with cancer.Methods: Sixty individuals with cancer diagnosed in the previous 6 months and receiving treatment with curative intent were randomised to receive either the 6-week intervention Cancer Coping Online (CCO: n = 30) or the 6-week Web-based attention control (n = 30). Outcome measures, including cancer distress (the Posttraumatic Stress Scale - Self-Report), general distress (Depression Anxiety Stress Scale), quality of life (EORTC QLQ-C30), and coping (mini-MAC), were administered at baseline, immediately post-intervention, and at 3 and 6 months post-intervention.Results: Significant main effects for time were found for cancer distress, global QOL, physical function, role function, social function, and anxious preoccupation. Post hoc between-group comparisons showed CCO participants had statistically significantly higher physical functioning compared to controls at 3 months of follow-up (d = -0.52, p = 0.02). Furthermore, compared to controls, post hoc comparisons found moderate between-group effect sizes favouring CCO post-intervention for cancer distress (d = 0.43) and anxious preoccupation (d = 0.38), and at 6 months of follow-up for global QOL (d = -0.43).Conclusions: These results provide preliminary support for the potential efficacy of a self-guided Web-based CBT programme in improving aspects of HRQOL, cancer-related distress, and anxious preoccupation after cancer diagnosis. This paper provides justification for, and will help inform the development of, subsequent larger multi-site studies. [ABSTRACT FROM AUTHOR]

Purpose: To assess and compare health information wanted and obtained from doctors/nurses by Chinese cancer patients and family caregivers.Research Questions: (1) What are the instrument's psychometrics in Chinese cancer patients and family caregivers? (2) How might Chinese cancer patients and family caregivers differ in the amount of different types of health information they want to have? and (3) How might Chinese cancer patients and family caregivers differ in the amount of different types of information they were able to obtain from doctors/nurses?Methods: This was a cross-sectional study using a paper-pen questionnaire. A total of 198 participants (79 cancer patients; 119 family caregivers) from a general hospital in Sichuan, China completed the instrument in March 2014.Results: The instrument has excellent reliability and validity. Participants wanted to have a wide range of health information, including but not limited to information about diagnosis or treatment. Across all types of information, participants obtained from doctors/nurses significantly less than what they wanted. The discrepancy between information wanted and obtained varied across different types of information. The discrepancy was largest for information about complementary and alternative medicine (CAM) and psychosocial aspects and smallest for information about diagnosis and self-care. Patients and caregivers did not differ in the amount of different types of information they wanted or obtained from medical professionals.Conclusions: There is a great need for providing more information to both patients and their families, particularly information about CAM and psychosocial aspects. [ABSTRACT FROM AUTHOR]

Background: Early and integrated specialized palliative care is often recommended but has still only been investigated in relatively few randomized clinical trials.Objective: To investigate the effect of early specialized palliative care plus standard care versus standard care on the explorative outcomes in the Danish Palliative Care Trial (DanPaCT).Methods: We conducted a randomized multicentre, parallel-group clinical trial. Consecutive patients with metastatic cancer were included if they had symptoms or problems that exceeded a predefined threshold according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Outcomes were estimated as the differences between the intervention and the control groups in the change from baseline to the weighted mean of the 3- and 8-week follow-ups measured as areas under the curve.Results: In total, 145 patients were randomized to early specialized palliative care plus standard care versus 152 to standard care only. Early specialized palliative care had no significant effect on any of the symptoms or problems. Of the 21 items addressing satisfaction, specialized palliative care improved the item 'overall satisfaction with the help received from the health care system' with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05).Conclusion: In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems. However, patients in the intervention group seemed more satisfied with the health care received than those in the standard care group.Trial Registration: NCT01348048. [ABSTRACT FROM AUTHOR]

The issue of whether, how and how much to tell cancer patients about their diagnosis and prognosis is confronted in different ways in different countries. This paper reflects my direct experience as a medical oncologist both in the US and in Italy. It is an attempt to describe two different ways of dealing with truth-telling in oncology and to explore their reasons and consequences. [ABSTRACT FROM AUTHOR]

Aim: The combination of cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors plus endocrine therapy (ET) improved the survival outcomes and became the standard of care in the treatment of metastatic hormone-positive breast cancer. However, these combinations increased the risk of neutropenia compared with ET alone. While the infection-related mortalities did not seem to be increased, the exact risk of infections with CDK 4/6 inhibitor and ET combinations is relatively understudied. Therefore, we performed a meta-analysis of CDK 4/6 inhibitor clinical trials to assess the infection risk of adding CDK4/6 inhibitors to ET.Material and Method: We systemically searched the PubMed database for relevant clinical trials. For each study, all grade and grade 3 or higher infections, upper respiratory tract infections (URTI), urinary tract infections (UTI), pneumonia, and febrile neutropenia rates were recorded whenever available. The hazard ratios (HR) with a 95% confidence interval (CI) of infection risk were calculated via the generic inverse-variance method with a random-effects model.Results: Nine eligible studies were included in the analyses (MONALEESA-2,3,7, MONARCH-2,3, MONARCH plus, PALOMA-1,2,3). In the meta-analysis of these studies, CDK 4/6 inhibitors plus ET arms were associated with increased all grade infections (HR 1.77, 95% CI 1.56-2.01, p < 0.00001), grade 3 or higher infections, (HR 1.77, 95% CI 1.28-2.43, p = 0.0005), UTIs (HR 1.59, 95% CI 1.19-2.12, p = 0.002), and febrile neutropenia (HR 4.28, 95% CI 1.73-10.62, p = 0.002).Conclusion: In this meta-analysis, we observed that adding CDK4/6 inhibitors to ET significantly increased the risk of all grade, grade 3 or higher infections, and urinary tract infections. We propose that closer follow-up for infections should be considered for metastatic breast cancer patients using CDK 4/6 inhibitors. This may help clinicians to recognize infections earlier which prevents early death from infection. [ABSTRACT FROM AUTHOR]

Purpose: Behavioral interventions have been used with breast cancer survivors (BCS) in cancer pain management and post-treatment quality of life (QOL) studies. We studied the effects of an anti-inflammatory dietary intervention on QOL in BCS.Methods: One hundred fifty-three overweight and obese (body mass index [BMI] ≥ 25 kg/m2), early stage (0-III), English-speaking BCS who had completed all cancer treatment 2 or more months prior to enrollment were recruited into a two-arm randomized controlled trial with a 2 (group) by 3 (time) repeated measures design. Intervention components included six monthly food-preparation workshops and twelve motivational interviewing telephone calls. Endpoints included the Perceived Stress Scale (PSS), the Functional Assessment of Cancer Therapy-General (FACT-G) and Breast Cancer (FACT-B), and the Center for Epidemiologic Studies Depression Scale (CES-D). Repeated measures analysis using PROC MIXED in SAS version 9.4 was used.Results: On repeated measures analysis (intent to treat), there were no differences between groups on any of the QOL outcomes except the PSS total scores. These were significantly different in the intervention group (IG; n = 76) compared to control group (CG; n = 77), showing a main effect of assignment but no effect of time and no interaction effects.Conclusion: There was an impact on QOL as measured by the PSS between groups. The intervention reduced perceived stress at 6-month follow-up, but the effects dissipated by 12 months. Sources and stress and stress reduction should be a focus of future studies. Future research should also identify appropriate QOL measures that are sensitive to changes brought about by behavioral interventions. [ABSTRACT FROM AUTHOR]

Purpose: Dysgeusia is an adverse event caused by chemotherapy. Although retrospective studies have shown zinc administration improves dysgeusia, there have been no prospective studies. The present study examined effects of zinc therapy on dysgeusia in patients with gastrointestinal cancer.Methods: This multicenter, prospective, observational study enrolled patients with dysgeusia during chemotherapy treatment. Patients received no intervention (control), polaprezinc p.o., or zinc acetate hydrate p.o., and serum zinc levels were measured at 0 (baseline), 6, and 12 weeks. Dysgeusia was assessed using CTCAE v5.0 and subjective total taste acuity (STTA) criteria using questionnaires at baseline and 12 weeks.Results: From February 2020 to June 2021, 180 patients were enrolled from 17 institutes. There were no differences in mean baseline serum zinc levels among the groups (67.3, 66.6, and 67.5 μg/dL in the no intervention, polaprezinc, and zinc acetate hydrate groups, respectively. P = 0.846). The changes in mean serum zinc levels after 12 weeks were - 3.8, + 14.3, and + 46.6 μg/dL, and the efficacy rates of dysgeusia were 33.3%, 36.8%, and 34.6% using CTCAE and 33.3%, 52.6%, 32.7% using STTA in the no intervention, polaprezinc, and zinc acetate hydrate groups, respectively. The STTA scores improved in all groups, with significant improvement observed in the polaprezinc group compared with the no intervention group (P = 0.045).Conclusion: There was no significant correlation between the degree of serum zinc elevation and improvement in dysgeusia, suggesting that polaprezinc, but not zinc acetate hydrate, was effective in improving chemotherapy-induced dysgeusia.Trial Registration: UMIN000039653. Date of registration: March 2, 2020. [ABSTRACT FROM AUTHOR]

Context: Pain management in palliative care remains inadequate; the development of innovative therapeutic options is needed. Objectives: To determine the feasibility and preliminary effectiveness for larger randomised controlled trials of 3D head-mounted (HMD) virtual reality (VR) for managing cancer pain (CP) in adults. Methods: Thirteen people receiving palliative care participated in a single-session randomised cross-over trial, after which they completed a qualitative semi-structured interview. We also compared the effects of 3D HMD VR and 2D screen applications on CP intensity and levels of perceived presence. Feasibility was assessed with recruitment, completion rates and time required to recruit target sample. Results: Although recruitment was slow, completion rate was high (93%). Participants reported that the intervention was acceptable and caused few side effects. Although participants reported significantly reduced CP intensity after 3D HMD VR (1.9 ± 1.8, P =.003) and 2D screen applications (1.5 ± 1.6, P =.007), no significant differences were found between interventions (−.38 ± 1.2, 95% CI: −1.1–.29, P =.23). Participants reported significantly higher levels of presence with the 3D HMD VR compared to 2D screen (60.7 ± SD 12.4 versus 34.3 ± SD 17.1, mean 95% CI: 16.4–40.7, P =.001). Increased presence was associated with significantly lower pain intensity (mean 95% CI: −.04–−0.01, P = 0.02). Conclusions: Our preliminary findings support growing evidence that both 3D and 2D virtual applications provide pain relief for people receiving palliative care. Given the relative lack of cybersickness and increasing access to portable VR, we suggest that larger clinical studies are warranted. [ABSTRACT FROM AUTHOR]

Background: In cancer care, shared decision-making (SDM) is especially relevant as different treatment options have a different impact on prognosis and patients' quality of life. However, evidence suggests that SDM is not routinely practiced. Furthermore, literature is mostly focussed on the outpatient setting. This study explored healthcare providers' perspectives on SDM for oncology inpatients and identified barriers and facilitators. Method: In this qualitative study, focus groups and semi-structured interviews were held with five nurses, eleven residents, four oncologists, and two healthcare managers caring for oncology inpatients of the Elisabeth-TweeSteden hospital. Results: Healthcare professionals do not always clearly state when a decision is required. On a patient level, comprehension barriers, language barrier, and distraction by emotions or sickness are recognized as barriers for adequate patient's communication. On a healthcare professional level, having awareness to inform about choices, being able to transfer this information, connecting to the patient, having substantial experience, and a good patient-physician relationship were facilitators. On an organizational, level, time, private rooms, continuity in care, and suboptimal use of the electronic health record were barriers. Conclusion: While SDM is recognized and valued, its implementation is inconsistent. Addressing the several barriers found and optimizing the facilitators is imperative. A start could be by raising awareness for SDM in the inpatient setting, adding SDM as part of the care pathway, stating to patients when a decision is required, reporting on the SDM process in the electronic health record, and describing the nurses' role in SDM. [ABSTRACT FROM AUTHOR]

Purpose: To describe oncology nurses' perspectives regarding survivorship care plan (SCP) components and implementation for colorectal cancer (CRC) survivors in Thailand.Methods: A cross-sectional, descriptive online study was conducted between October and November 2020. Thai oncology nurses were recruited using Facebook and the Line application. Study participants (n = 160) rated the usefulness of four standard SCP components (treatment summaries, surveillance, late/long-term effects, and health promotion and psychosocial needs; n = 23 items) and gave input on the implementation of SCPs in clinical practice (n = 11 items). Data were analyzed using descriptive statistics.Results: Most oncology nurses supported providing CRC survivors with SCPs (93.2%) and felt that SCPs were an important part of their practice (93.7%). Nurses rated all four SCP components as "very useful," including treatment summaries (76.4%), surveillance (81.9%), late/long-term effects (85.7%), and health behavior and psychosocial concerns (80.2%). In terms of implementation, most nurses indicated that oncologists should prepare (84.4%) and provide SCPs (95%), but 61.9% and 69.4% of nurses, respectively, also believed that they should perform these tasks. In addition, most nurses indicated that they should play a significant role in the ongoing management of CRC survivors (95.7%) and that evidence-based surveillance guidelines are needed (96.2%).Conclusion: Oncology nurses believed that the four SCP components were helpful to the long-term management of CRC survivors, supported SCP provision, and expressed their perceived responsibilities for preparing and delivering SCPs. The findings suggested opportunities for oncology nurses to play a significant role in developing and implementing SCPs. However, additional efforts are needed to expand nurses' roles in survivorship care and establish practice guidelines that will facilitate integration of SCPs into nursing practice. [ABSTRACT FROM AUTHOR]

Purpose: Despite increasing development in decision-making strategies for patients with prostate cancer, little is known about patients' individual experience and perception throughout the decision-making process. The objective of this study was to explore patients' experiences and perceptions towards treatment decision-making. Methods: We conducted a qualitative interview study with 30 patients diagnosed with prostate cancer. We transcribed interviews verbatim and inductively identified codes. Thematic analysis was used to develop and refine a codebook that aided in the identification of themes. Results: Three key themes and nine subthemes emerged, which were as follows: I. less involved in treatment decision-making, (i) passive decisional control, (ii) lack of medical knowledge, and (iii) domination by family members; II. the right to be informed of the disease condition and to choose treatment options, (i) sociocultural influences, (ii) patients believe that they should know the true facts of the disease, and (iii) patient autonomy during treatment; and III. future consideration and advance care planning, (i) fewer future concerns, (ii) advance care planning is poorly understood, and (iii) acceptance of advance care planning. Conclusion: The study results show that patients with prostate cancer have a diversity of needs to cultivate their ability to make treatment decisions, and healthcare professionals should empower patients, as well as provide decision aids or decision support for patients. [ABSTRACT FROM AUTHOR]

Not monitoring adherence to oral anticancer therapies (OAT) can lead to poor clinical outcomes, including premature death as reported by Foulon et al. (Acta Clin Belg 66(2):85–96, 2011) and Greer et al. (Oncologist 21(3):354–76, 2016). Barriers to the implementation of supportive cancer care interventions in medication adherence occur with multiple hospital sites, cancer diagnoses, and numerous healthcare professionals. This commentary describes challenges and strategies from two OAT adherence trials in Australia and Switzerland to assist researchers in the design and implementation of future interprofessional trials. [ABSTRACT FROM AUTHOR]

Purpose: Abiraterone acetate, prescribed for metastatic prostate cancer, has enhanced absorption with food. This effect was exploited in a randomized trial which showed noninferiority of PSA decline for 250 mg abiraterone with a low-fat meal (LOW) compared to 1,000 mg abiraterone fasting (STD). Drug was obtained via patient insurance. Patient out-of-pocket costs and adherence were surveyed.Methods: Trial participants were randomized to STD or LOW, and surveys of adherence and out-of-pocket costs were administered at baseline and just before coming off study (follow-up).Results: Out-of-pocket costs were available from 20 of 36 STD and 21 of 36 LOW patients. Median out-of-pocket costs for a month of drug were $0 (LOW) and $5 (STD); mean costs were $43.61 (LOW) and $393.83 (STD). The two groups did not differ significantly (p = 0.421). Maximum out-of-pocket cost was $1,000 (LOW) and $4,000 (STD). Monthly out-of-pocket costs > $500 were found in 1 LOW and 5 STD patients. For adherence, only 11 STD and 19 LOW patients had questionnaires completed at both baseline and follow-up. STD adherence was 98.18% at baseline and 91.69% at follow-up, differing significantly (p = 0.0078). LOW adherence was 96.52% at baseline and 97.86% at follow-up, not differing significantly (p = 0.3511). Adherence did not correlate with demographics. At follow-up, increasing adherence correlated significantly with decreasing dose (p = 0.013; rho =  - 0.458).Conclusions: Out-of-pocket costs did not differ significantly in this limited analysis. Adherence was significantly different in STD as the trial progressed, which was not found in LOW.Trial Registration: ClinicalTrials.gov NCT01543776; registered March 5, 2012. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the prevalence of adjustment disorder (AD) among cancer patients and the acceptance of psychological treatment, in relation to sociodemographic, clinical, and psychological factors.Methods: Breast, prostate, and head and neck cancer patients of all stages and treatment modalities (N = 200) participated in this observational study. Patients completed the Hospital Anxiety and Depression Scale, Checklist Individual Strength, Distress Thermometer and problem list. Patients with increased risk on AD based on these questionnaires were scheduled for a diagnostic interview. Patients diagnosed with AD were invited to participate in a randomized controlled trial on the cost-effectiveness of psychological treatment. Participation in this trial was used as a proxy of acceptance of psychological treatment. Logistic regression analyses were used to investigate associated factors.Results: The overall prevalence of AD was estimated at 13.1%. Sensitivity analyses showed prevalence rates of AD of 11.5%, 15.0%, and 23.5%. Acceptance of psychological treatment was estimated at 65%. AD was associated both with being employed (OR = 3.3, CI = 1.3-8.4) and having a shorter time since diagnosis (OR = 0.3, CI = 0.1-0.8).Conclusion: Taking sensitivity analysis into account, the prevalence of AD among cancer patients is estimated at 13 to 15%, and is related to being employed and having a shorter time since diagnosis. The majority of cancer patients with AD accept psychological treatment. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the effectiveness of an Oral Health Education and Prevention Program (OHEPP) on the incidence and severity of oral mucositis (OM) in pediatric cancer patients. The OHEEP was a ludic strategy for promoting oral health and monitoring the oral health condition.Methods: We compared the incidence and severity of OM in patients who attended the OHEPP against those under similar conditions who did not receive educational interventions. Both groups were examined for 6 weeks by calibrated examiners (k > 0.8) using the modified Oral Assessment Guide (OAG). A total of 14 patients aged 2 to 18 years were included in each group and matched for sex, age, tumor type, and treatment modality. The incidence and severity of OM were compared using the chi-squared test (α = 5%), and the relative risk and effectiveness of the OHEPP were calculated with a statistical power of 0.97. Differences in total OAG scores between the groups were determined by the Mann-Whitney test (α = 5%).Results: There was a higher incidence of OM in patients who did not attend the OHEPP (P = 0.005), and the relative risk of developing OM was significantly lower in OHEPP attendants (RR: 0.73; CI 0.60-0.92). No difference in the occurrence of severe OM was observed. OHEPP reduced the risk of developing OM by 1.4-fold, with an effectiveness of 27%. There was a difference in total OAG scores (P = 0.041).Conclusion: Participation in OHEPP was an effective measure to reduce the incidence of OM in pediatric cancer patients. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the work situation of lung cancer survivors and to identify the factors associated with their returning to work.Methods: Descriptive analysis and logistic regression were used to evaluate study population characteristics and independent factors of subsequently returning to work. To analyze time to return to work, Cox regression was used.Results: The study sample included 232 lung cancer survivors of working age from 717 enrolled participants in the multi-center cross-sectional LARIS (Quality of Life and Psychosocial Rehabilitation in Lung Cancer Survivors) study. About 67% of the survivors were not employed during the survey. More than 51% of the survivors who were employed before their illness did not return to their work. The survivors who had returned to their careers were younger, associated with higher household income, lower fatigue score, and stable relationship and vocational training. Patients who received social service counseling showed a higher chance of regaining their career.Conclusions: Lung cancer survivors were found to be associated with a high risk of unemployment and very low professional reintegration after interruption due to illness. More comprehensive studies are needed to support lung cancer survivors and targeting of patients in need of special attention in rehabilitation that would benefit from the findings in the present study. [ABSTRACT FROM AUTHOR]

Purpose: Patients' readiness for advance care planning (ACP) is often considered a prerequisite for starting ACP conversations. Healthcare professionals' uncertainty about patients' readiness hampers the uptake of ACP in clinical practice. This study aims To determine how patients' readiness is expressed and develops throughout an ACP conversation.Methods: A qualitative sub-study into the ACTION ACP conversations collected as part of the international Phase III multicenter cluster-randomized clinical trial. A purposeful sample was taken of ACP conversations of patients with advanced lung or colorectal cancer who participated in the ACTION study between May 2015 and December 2018 (n = 15). A content analysis of the ACP conversations was conducted.Results: All patients (n = 15) expressed both signs of not being ready and of being ready. Signs of being ready included anticipating possible future scenarios or demonstrating an understanding of one's disease. Signs of not being ready included limiting one's perspective to the here and now or indicating a preference not to talk about an ACP topic. Signs of not being ready occurred more often when future-oriented topics were discussed. Despite showing signs of not being ready, patients were able to continue the conversation when a new topic was introduced.Conclusion: Healthcare professionals should be aware that patients do not have to be ready for all ACP topics to be able to participate in an ACP conversation. They should be sensitive to signs of not being ready and develop the ability to adapt the conversation accordingly. [ABSTRACT FROM AUTHOR]

Purposes: Being diagnosed with oral cancer is a life-threatening life event. It often induces social, emotional and psychological consequences and may cause depressive disorders. The primary aim of this study was to identify and quantify the personal and clinical characteristics involved in depression for patients who have been treated for oral cavity malignancies, with a 5-year follow-up period after treatment. The secondary aim of this study was to identify the clinical factors that increase a patient's risk of experiencing depression 5 years after treatment.Methods: Patients with primary oral cancer were assessed for up to 5 years after primary treatment. A mixed-model analysis was performed, with depression measured by the Center for Epidemiologic Studies Depression Scale as outcome measure.Results: A total of 141 patients were included in the study. Factors associated with depression were gender, tumour location and having an emotion-oriented coping style. The occurrence of depression within 5 years after treatment could be reliably predicted by a patient's gender, the location of their tumour and the extent to which they had an emotion-oriented coping style.Conclusions: This study revealed that being female, having a maxillary tumour and having an emotion-oriented coping style are associated with higher levels of depressive symptoms in patients treated for oral cancer up to 5 years post-treatment. A substantial proportion of the patients with oral cancer experienced high levels of depression both before and after their treatment, suggesting that adequate diagnostics and care are needed to try to prevent severe depression in these patients. [ABSTRACT FROM AUTHOR]

The special circumstances surrounding a terminally ill patient require that a classification system for case-mix and staging take quality of life as its main endpoint. From all possible variables relevant to the case-mix description, a small group of variables relating to the functional status, physical symptoms, psychocognitive problems, and financial status have been isolated in order to identify a limited number of groups of patient who differ in terms of quality of life and/or survival throughout the entire period of treatment in a palliative care unit (PCU). The study is still in progress and involves an estimated sample of about 900 terminal cancer patients being cared for in 61 PCUs in Italy. This paper provides information about the rationale and objectives of the study and the methods used. [ABSTRACT FROM AUTHOR]

The field of high-dose chemotherapy with stem cell transplantation has been expanded recently as a treatment for solid tumors and hematological malignancies. Severe emesis remains one of the main extramedullary side-effects of high-dose regimens during the first week of treatment. Traditional antiemetics such as chlorpromazine, diazepam, and phenothiazines are extensively used but are unable to control emesis. The new antiemetic ondansetron, a serotonin receptor (5HT3) antagonist appears to be superior to these drugs for cisplatin-induced emesis. The study we present here is an attempt to control emesis following high-dose regimens, during bone marrow or peripheral stem cell transplantation, with ondansetron. To our knowledge no other paper has reported the efficacy of this antiemetic in such group of patients. A total of 29 patients who received highly emetogenic polychemotherapy as conditioning regimens for bone marrow transplantation were treated with ondansetron, which was given as an 8-mg i.v. short infusion prior the initiation of treatment and every 6 h thereafter for 3 days, and an 8-mg dose every 8 h for 5 additional days. All the patients had previously been treated with chemotherapy and were evaluable for response and toxicity. Complete and major protection of vomiting on day 1 was achieved by 76% of the patients, 58% on day 2 and 52% on day 3. Nausea was absent or mild in 79% of patients on day 1, 45% on day 2 and 41% on day 3.(ABSTRACT TRUNCATED AT 250 WORDS) [ABSTRACT FROM AUTHOR]

Background: The use of patient-reported outcomes (PROs) for routine cancer distress screening is endorsed globally as a quality-care standard. However, there is little research on the integration of PROs in "real-world" oncology practices using implementation science methods. The Improving Patient Experience and Health Outcome Collaborative (iPEHOC) intervention was established at multisite disease clinics to facilitate the use of PRO data by clinicians for precision symptom care. The aim of this study was to examine if patients exposed to the intervention differed in their healthcare utilization compared with contemporaneous controls in the same time frame.Methods: We used a PRE- and DURING-intervention population cohort comparison study design to estimate the effects of the iPEHOC intervention on the difference in difference (DID) for relative rates (RR) for emergency department (ED) visits, hospitalizations, psychosocial oncology (PSO), palliative care visits, and prescription rates for opioids and antidepressants compared with controls.Results: A small significantly lower Difference in Difference (DID) (- 0.223) in the RR for ED visits was noted for the intervention compared with controls over time (0.947, CI 0.900-0.996); and a DID (- 0.0329) for patients meeting ESAS symptom thresholds (0.927, CI 0.869-0.990). A lower DID in palliative care visits (- 0.0097), psychosocial oncology visits (- 0.0248), antidepressant prescriptions (- 0.0260) and an increase in opioid prescriptions (0.0456) in the exposed population compared with controls was also noted. A similar pattern was shown for ESAS as a secondary exposure variable.Conclusion: Facilitating uptake of PROs data may impact healthcare utilization but requires examination in larger scale "real-world" trials. [ABSTRACT FROM AUTHOR]

Purpose: Radiotherapy to the prostate gland and pelvic lymph nodes may cause acute and late bowel symptoms and diminish quality of life. The aim was to study the effects of a nutrition intervention on bowel symptoms and health-related quality of life, compared with standard care.Methods: Patients were randomised to a nutrition intervention (n = 92) aiming to replace insoluble fibres with soluble and reduce intake of lactose, or a standard care group (n = 88) who were recommended to maintain their habitual diet. Bowel symptoms, health-related quality of life and intake of fibre and lactose-containing foods were assessed up to 24 months after radiotherapy completion. Multiple linear regression was used to analyse the effects of the nutrition intervention on bowel symptoms during the acute (up to 2 months post radiotherapy) and the late (7 to 24 months post radiotherapy) phase.Results: Most symptoms and functioning worsened during the acute phase, and improved during the late phase in both the intervention and standard care groups. The nutrition intervention was associated with less blood in stools (p = 0.047), flatulence (p = 0.014) and increased loss of appetite (p = 0.018) during the acute phase, and more bloated abdomen in the late phase (p = 0.029). However, these associations were clinically trivial or small.Conclusions: The effect of the nutrition intervention related to dietary fibre and lactose on bowel symptoms from pelvic RT was small and inconclusive, although some minor and transient improvements were observed. The results do not support routine nutrition intervention of this type to reduce adverse effects from pelvic radiotherapy. [ABSTRACT FROM AUTHOR]

Background: Anorexia-cachexia syndrome (ACS) is a complex condition in advanced cancer patients, defined by disproportionate loss of skeletal muscle mass, and a lack or loss of appetite. This condition greatly lowers the quality of life and limits the treatment options. ACS is commonly associated with gastrointestinal symptoms such as nausea and vomiting. Ginger has been successful in treating these symptoms but has not yet been tested on patients with advanced cancer. Electrogastrography is a technology that allows the direct recording of the gastric myoelectrical activity (GMA).Purpose: The aim of this study is to (1) determine the effects of ginger on the GMA in these patients, (2) evaluate the subjective symptoms using 3 validated scales, and (3) correlate the level of inflammatory factors and ghrelin in this patient population.Methods: Patients with ACS and advanced cancer were recruited from the Palliative Rehabilitation outpatient program at Elisabeth Bruyère Hospital. Patients were instructed to take a daily capsule of 1650 mg of ginger for 14 days and outcome measures were recorded at pre- and post-intervention, which included a blood test for analysis of CRP, albumin and ghrelin levels, 3 self-administered surveys (DSSI, PG-SGA, ESAS), patient-reported symptoms, and an EGG diagnosis.Results: Fifteen patients with a median age of 58 and varying cancer diagnoses were enrolled. EGG diagnosis showed that 9 of the 15 patients had a direct improvement in their GMA, and all patients showed improvement in reported symptoms, most notably nausea, dysmotility- and reflux-like symptoms. There was no correlation found for ginger administration and inflammatory factors.Conclusion: These findings suggest that ginger may improve GMA as measured by EGG and may have a notable effect on symptom improvement. [ABSTRACT FROM AUTHOR]

Purpose: The causal link between chemotherapy and cognitive impairment is unclear. We studied testicular cancer patients' objective and subjective cognitive function longitudinally, comparing a surgery group with a surgery + chemotherapy group, addressing prior methodological issues using a computerized test to limit assessment issues, and controlling for confounding variables.Methods: Prospectively, of 145 patients from 16 centres with sufficient data, n = 61 receiving surgery + chemotherapy (etoposide and cisplatin ± bleomycin, BEP/EP; or single agent carboplatin) were compared to n = 41 receiving surgery alone. CogHealth assessed six objective cognitive tasks. The Cognitive Failures Questionnaire assessed self-perceived cognitive dysfunction. The Functional Assessment of Chronic Illness Therapy-Fatigue and the Hospital Anxiety and Depression Scale assessed psychological influences. Linear mixed models compared changes from baseline (< 6 months post-surgery/pre-chemotherapy) to follow-up (12-18 months post-baseline), controlling covariates.Results: There were no significant interaction effects for five objective cognitive function tasks suggesting that changes over time were not due to group membership. However, psychomotor function (controlling for age) and physical well-being were significantly worse for the chemotherapy versus the surgery group at baseline, with groups converging by follow-up. Groups showed no differences in subjective cognitive dysfunction. The chemotherapy group showed higher anxiety, poorer functional well-being and worse fatigue compared to the surgery-only group at baseline, but not by follow-up. For both groups, emotional well-being, functional well-being and anxiety significantly improved over time.Conclusion: No substantive differences in objective or subjective cognitive dysfunction in either group persisted 12-18 months post-baseline. Patients undergoing chemotherapy for testicular cancer differ from findings in breast cancer populations.Trial Registration: ClinicalTrials.gov Identifier: ACTRN12609000545268. [ABSTRACT FROM AUTHOR]

Purpose: Malnutrition (MN) in cancer is common but underdiagnosed. Dietitian referrals may not occur until MN is established. We investigated cancer patient characteristics (demographics, nutritional status, and nutrition barriers) on referral to oncology dietitians. We also examined referral practices and prevalence of missed referral opportunities.Methods: This was a naturalistic multi-site study of clinical practice. Data from consecutive referrals were collected in inpatient and outpatient settings. Demographics, nutritional status (weight, body mass index (BMI), weight loss in the preceding 3-6 months, oral intake, nutrition barriers), referral reasons, and use of screening were recorded. Missed opportunities for earlier referral were also noted.Results: Two hundred patients were included (60% male, 51% inpatients). Half had gastrointestinal and hepatobiliary cancers. The majority were on antitumor treatment. Two-thirds had lost ≥ 5% body weight. Forty percent were overweight or obese. Seventy percent had ≥ 2 nutritional barriers. Most common nutrition barriers were anorexia, nausea, and early satiety. Greater weight loss and lower food intake were associated with ≥ 2 barriers. Weight loss was the most common referral reason. Screening was used in 35%. Referrals should have occurred sooner in nearly half (45%, n = 89).Conclusions: Cancer patients were referred late to a dietitian, with multiple nutritional barriers. Most referrals were for established weight loss (WL). WL may be masked by pre-existing obesity. Almost half had missed earlier referral opportunities; screening was infrequent. Over one-quarter should have been re-referred sooner. There is a clear need for clinician education. Future research should investigate the optimal timing of dietitian referral and the best nutrition screening tools for use in cancer. [ABSTRACT FROM AUTHOR]

Purpose: To examine symptom responses resulting from a home-based reflexology intervention delivered by a friend/family caregivers to women with advanced breast cancer undergoing chemotherapy, targeted, and/or hormonal therapy.Methods: Patient-caregiver dyads (N = 256) were randomized to 4 weekly reflexology sessions or attention control. Caregivers in the intervention group were trained by a reflexology practitioner in a 30-min protocol. During the 4 weeks, both groups completed telephone symptom assessments using the M. D. Anderson Symptom Inventory. Those who completed at least one weekly call were included in this secondary analysis (N = 209). Each symptom was categorized as mild, moderate, or severe using established interference-based cut-points. Symptom response meant an improvement by at least one category or remaining mild. Symptom responses were treated as multiple events within patients and analyzed using generalized estimating equations technique.Results: Reflexology was more successful than attention control in producing responses for pain (OR = 1.84, 95% CI (1.05, 3.23), p = 0.03), with no significant differences for other symptoms. In the reflexology group, greater probability of response across all symptoms was associated with lower number of comorbid condition and lower depressive symptomatology at baseline. Compared to odds of responses on pain (chosen as a referent symptom), greater odds of symptom response were found for disturbed sleep and difficulty remembering with older aged participants.Conclusions: Home-based caregiver-delivered reflexology was helpful in decreasing patient-reported pain. Age, comorbid conditions, and depression are potentially important tailoring factors for future research and can be used to identify patients who may benefit from reflexology.Trial Registration: ClinicalTrials.gov Identifier: NCT01582971. [ABSTRACT FROM AUTHOR]

Purpose: The newly developed "Herlev Hospital Empowerment of Relatives through More and Earlier information Supply" (HERMES) intervention systematically identifies cancer caregivers' unmet needs for information from health care professionals (HCPs) and offers them the information they lack. The aim of this study was to investigate the effect of the HERMES intervention on caregivers' perception of information, communication, attention and help from HCPs, fulfillment of care needs, and anxiety and depression.Methods: A randomized intervention study with immediate intervention in the intervention group and delayed intervention (after follow-up) in the control group among caregivers of cancer patients starting chemotherapy.Results: Totally 199 caregivers were included (intervention group, n = 101; control group, n = 98). No intervention effect was found on overall satisfaction with information from HCPs (p = 0.1687) measured by a single item from the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN) and chosen as primary outcome. However, positive effects were found on the CaTCoN subscales "Problems with the quality of information from and communication with HCPs" (p = 0.0279), "Lack of information from HCPs (HERMES)" (p = 0.0039), and "Lack of attention on the caregivers' wellbeing from HCPs" (p < 0.0001). No effect was found on the CaTCoN subscale "Need for help from HCPs", the Family Inventory of Needs subscale regarding fulfillment of care needs, or the Hospital Anxiety and Depression scale.Conclusions: Although no effect was found on overall satisfaction with information, the HERMES intervention had positive effects on the caregivers' experiences of the amount of information and attention given to them and the quality of information and communication.Trial Registration: ClinicalTrials.gov (Identifier: NCT02380469). [ABSTRACT FROM AUTHOR]

Purpose: Local/systemic symptoms during cancer therapy may be exacerbated by dysregulated inflammation and its downstream toxic effects. Minocycline can suppress proinflammatory cytokine release; therefore, we investigated its potential to reduce patient-reported symptom severity during radiotherapy (RT) for head and neck cancer (HNC).Methods: Eligible patients for this blinded, placebo-controlled trial were adults with T0-3, N-any, and M0 HNC receiving single-modality RT. Participants were randomized 1:1 to either minocycline (200 mg/day) or placebo during RT. The primary endpoint was the area under the curve (AUC) of 5 prespecified symptoms (pain, fatigue, disturbed sleep, poor appetite, difficulty swallowing/chewing) during RT, assessed with the MD Anderson Symptom Inventory for HNC (MDASI-HN).Results: We analyzed data from 20 evaluable patients per arm. Overall, 75% had oropharyngeal cancer and 78% were male. No grade 3+ adverse events potentially related to study medication were observed. Two minocycline patients required a feeding tube during RT vs 5 placebo patients (P = 0.21). The average daily AUC during RT for the 5 MDASI-HN symptoms was 3.1 (SD = 1.0) for minocycline and 3.7 (SD = 1.7) for placebo (P = 0.16); the 0.37 effect size was less than our 0.70 target. AUC comparisons for several individual symptoms and symptom interference favored minocycline but were not statistically significant. The greatest numerical differences occurred for systemic symptoms, larger toward treatment end, and in early post-RT recovery.Conclusions: Minocycline was feasible, well tolerated, and achieved a positive signal toward reducing patient-reported symptom severity during RT for HNC, particularly for systemic symptoms. This justifies additional study and informs future trial design. [ABSTRACT FROM AUTHOR]

Purpose: We designed a novel, manualized intervention called Emotion And Symptom-focused Engagement (EASE) for acute leukemia (AL) and report here on a phase II randomized controlled trial (RCT) to assess its feasibility and preliminary efficacy.Methods: Patients were recruited within 1 month of hospital admission and randomized to EASE plus usual care (UC) or UC alone. EASE includes (1) EASE-psy, a tailored psychotherapy delivered over 8 weeks, and (2) EASE-phys, weekly physical symptom screening over 8 weeks to trigger early palliative care. The primary outcome was traumatic stress symptoms; secondary outcomes included physical symptom burden and quality of life. Assessments were conducted at baseline and at 4, 8, and 12 weeks. Between-group differences were evaluated using multilevel modeling.Results: Forty-two patients were randomized to EASE (n = 22) or UC (n = 20), with 76% retention at 12 weeks. Predefined feasibility outcomes were met: 86% (19/22) of EASE participants completed ≥ 50% of EASE-psy sessions (goal ≥ 64%); 100% received Edmonton Symptom Assessment System (ESAS, modified for AL) screenings, 64% (14/22) of whom completed ≥ 50% of planned screenings (goal ≥50%); and 100% with scores ≥ 4/10 on any physical ESAS-AL item had ≥ 1 meeting with the EASE-phys team (goal 100%). Significant treatment-group differences favoring EASE were observed in traumatic stress symptoms at 4 and 12 weeks, and pain intensity and interference at 12 weeks (all p < .05).Conclusions: EASE is feasible in patients newly diagnosed with AL and shows promise of effectiveness. These results warrant a larger RCT to provide evidence for its more routine use as a standard of care. [ABSTRACT FROM AUTHOR]

Purpose: Few studies are currently available among elderly patients, justifying the need for better understanding of daily medical practices in terms of use of growth factors to prevent chemotherapy (CT)-induced neutropenia. The primary objective of this study was to describe the use of filgrastim in the elderly.Methods: Cancer patients aged 65 years and above, undergoing CT and initiating a prophylactic treatment with filgrastim, were enrolled. Patients were followed according to routine medical practice from filgrastim initiation until the end of the CT or after a maximum of 6 cycles.Results: One thousand one hundred nineteen evaluable patients were documented in the study (mean age 73.9 ± 6.2 years, 52.1% men). The majority were suffering from solid tumor (73%) with ECOG 0-1 for 80% of them. Approximately two-third had a global risk for FN ≥ 20%, and one third < 20%. Through all CT cycles, no differences were observed between age classes ([65-74], [75-85], or > 85) in dose, duration, and time to first injection from CT start. Most patients (84%) received primary prophylaxis (PP) and 70% were administered during the first CT cycle. The median time from CT start until filgrastim was 4 days. The median duration of filgrastim treatment was 5 days. Dose reductions and CT delays were less frequent in patients receiving PP (4.8% and 7.1% respectively) than secondary prophylaxis (9.2% and 13.3% respectively).Conclusions: Filgrastim use was consistent with French Market Authorization terms. No difference was shown compared with younger patients. Safety data were consistent with the known safety profile. [ABSTRACT FROM AUTHOR]

Purpose: The Scored Patient-Generated Subjective Global Assessment (PG-SGA) is the only malnutrition (risk) assessment tool that combines patient-generated measures with professional-generated (medical) factors. We aimed to apply international standards to produce a high quality, validated, translation and cultural adaptation of the original PG-SGA for the Austrian, German, and Swiss setting.Methods: Analogue to methodology used for the Dutch, Portuguese, and Thai versions of PG-SGA, the ten steps of the International Society for Pharmacoeconomics and Outcomes Research's principles of good practice for translation and cultural adaptation were followed. Comprehensibility and difficulty of the translation were assessed in 103 patients and 104 healthcare professionals recruited from all three German-speaking countries. Content validity of the translation was assessed among healthcare professionals (HCP). Item and scale indices were calculated for content validity (I-CVI; S-CVI), comprehensibility (I-CI; S-CI), and difficulty (I-DI; S-DI).Results: Patients' perceived comprehensibility and difficulty of the PG-SGA fell within the range considered to be excellent (S-CI = 0.90, S-DI = 0.90), HCP-perceived content validity (S-CVI = 0.90) was also excellent, while HCP-perceived comprehensibility fell within the high range of acceptable (S-CI = 0.87). The professional component of the PG-SGA was perceived as below acceptable (S-DI = 0.72) with the physical exam being rated the most difficult (I-DI=0.29-0.75).Conclusions: The systematic approach resulted in a high-quality validation of the German language version of the PG-SGA, that is internationally comparable, comprehensible, easy to complete, and considered relevant for use in Austria, Germany and Switzerland. [ABSTRACT FROM AUTHOR]

Purpose: Life review therapy combined with memory specificity training (LRT-MST) is effective in cancer patients in palliative care, but the effect size is moderate. The aim of this qualitative study was to obtain more in-depth knowledge on motivation to start with LRT-MST, experiences with LRT-MST, and perceived outcomes of LRT-MST.Methods: Semi-structured interviews were conducted with 20 cancer patients in palliative care who participated in a randomized controlled trial investigating the effect of LRT-MST. All interviews were digitally recorded and transcribed verbatim. Data were analyzed by means of thematic analysis independently by two coders and coded into key issues and themes.Results: Patients started LRT-MST for intrinsic (e.g., potential benefit for personal well-being) and extrinsic reasons (e.g., potential benefit for future patients). Patients indicated mainly positive experiences with the intervention. They appreciated sharing their memories and regaining memories with a specific focus on retrieving positive memories. Some disliked the fact that negative memories could not be addressed. Most patients perceived positive outcomes of the intervention belonging to the overarching themes "ego-integrity" and "psychological well-being" in the here and now, as well as in the nearby future (including end-of-life).Conclusions: LRT-MST is of added value as a psychological intervention in palliative care. This study provided in-depth insight into reasons to start the intervention, and the experiences and outcomes, which are important to further tailor LRT-MST and for development or improvement of other psychological interventions targeting cancer patients in palliative care. [ABSTRACT FROM AUTHOR]

Purpose: This study evaluated the humanistic burden on caregivers of patients with advanced non-small cell lung cancer (aNSCLC) as the disease progresses.Methods: Data were drawn from a cross-sectional study of patients with aNSCLC and their caregivers conducted in France, Germany, and Italy between 2015 and 2016. Data were collected by medical chart review and patient and caregiver questionnaires. The EuroQol five-dimension three-level (EQ-5D-3L) was used to evaluate patient and caregiver health status. Caregivers also completed the Work Productivity and Activity Impairment (WPAI) questionnaire and Zarit Burden Interview (ZBI).Results: The population for the analysis consisted of 427 caregivers (mean age 53.5 years; 72.6% female; 54.9% spouse; 36.2% in full-time employment) and 427 matched patients (mean age 66.2 years; 68.6% male). Most (69.5%) patients were receiving first-line therapy for advanced disease. Patients' caregivers provided a mean of 29.5 h of support per week. Significant differences in EQ-5D-3L scores were observed between caregivers of patients receiving first and later lines of therapy in France (0.87 vs. 0.78; p = 0.0055). Among employed caregivers, overall work impairment was considerable and ranged from 21.1% in Germany to 30.4% in France and 29.7% in Italy. Caregivers of patients receiving later lines of therapy in France rated their own health status as significantly worse than did those caring for patients receiving first-line therapy (82.7 vs. 72.9; p = 0.0039).Conclusions: Informal caregivers provided the majority of support for patients with advanced NSCLC and their caregiving activities impose a significant humanistic burden. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study is to investigate the prevalence of pain, pain management, and impact of recent pain on daily functioning in patients with head and neck cancer (HNC) and patients with other cancers.Methods: This multi-center survey was conducted by using Brief Pain Inventory questionnaire to evaluate pain status and its impact on daily functioning.Results: A total of 3289 patients were analyzed including 708 HNC patients and 2581 patients with other cancers. The overall pain prevalence was 69.17%. A higher percentage of HNC patients had recent pain (60.59 vs. 44.01%, P < 0.001), required pain management (86.29 vs. 72.03%, P < 0.001), and used any analgesics (53.81 vs. 34.52%, P < 0.001). HNC patients with pain management had a higher prevalence of recent pain (85.83 vs. 81.14%, P = 0.044) and a slightly lower satisfaction rate (74.00 vs. 79.70%, P = 0.070). Regarding the impact of pain on daily functioning, HNC patients had a lower mean interference score for general activity such as walking, normal work, sleep, and life enjoyment.Conclusions: The HNC patients may need more intensive pain management to achieve optimal pain control and maintain daily functioning. [ABSTRACT FROM AUTHOR]

Purpose: Early detection and improved treatment have increased lung cancer survival. Lung cancer survivors have more symptom distress and lower function compared with other cancer survivors; however, few interventions are available to improve health-related quality of life (HR-QOL). Lifestyle risk reduction interventions have improved HR-QOL in other cancer survivors. The purpose of this study was to explore lung cancer survivor perspectives on making behavioral changes in the context of a lifestyle risk reduction intervention.Methods: Twenty-two lung cancer survivors participated in interviews after completing the Healthy Directions (HD) intervention. Interviews were audiotaped, transcribed, and analyzed using inductive content analysis. Demographic and clinical characteristics were gathered through a survey and analyzed using descriptive statistics.Results: Five main themes were identified: (1) the diagnosis was a motivator for behavior change, (2) participants had to deal with disease consequences, (3) the coach provided guidance, (4) strategies for change were initiated, and (5) social support sustained behavioral changes. Other important subthemes were the coach helped interpret symptoms, which supported self-efficacy and goal setting, and survivors employed self-monitoring behaviors. Several participants found the recommended goals for physical activity were difficult and were discouraged if unable to attain the goal. Findings underscore the need for individualized prescriptions of physical activity, especially for sedentary survivors.Conclusions: Lung cancer survivors described the benefits of coaching to enhance their engagement in behavioral change. Additional research is needed to validate the benefit of the HD intervention to improve HR-QOL among this vulnerable and understudied group of cancer survivors. [ABSTRACT FROM AUTHOR]

Background: There is a paucity of data about effective interventions to improve happiness and reduce burnout in oncologists. Benjamin Franklin developed a 13-week program of "necessary activities" or "virtues" (temperance, silence, order, resolution, frugality, industry, sincerity, justice, moderation, cleanliness, tranquility, chastity, and humility) to follow, in his attempt at self-improvement. In this pilot study, we explored whether using a modified version of this was associated with any discernable impact on physician happiness, burnout, or compliance with each of the virtues.Methods: Self-reported happiness (Oxford happiness scores) and burnout (Abbreviated Maslach Burnout Inventory) were completed at baseline (pre-study), week 13, and 1 month after completion of the program. Each day during the 13-week program, oncologists were emailed a list of virtues to focus on and scored how they felt they were complying with them. The oncologist's spouses also assessed how they felt the oncologist was complying with the virtues.Results: Thirteen physicians completed the baseline scores, 11 completed Maslach/Oxford scores at the end of the study, and 8 the 1-month post-study assessment. No significant improvements in happiness and burnout (emotional exhaustion, depersonalization, personal accomplishment) scores were observed. Statistically significant changes in self-rated virtue scores were observed for temperance (p = 0.046), order (p = 0.049), and resolution (p = 0.014). Additionally, although not reaching statistical significance, 11 of 13 virtues (excepting sincerity and chastity) assessed by spouses indicated a positive change over time.Conclusion: In this hypothesis generating study, daily reflection on personal virtues was not associated with any statistically significant change in happiness or burnout scores. Alternative strategies should be considered. [ABSTRACT FROM AUTHOR]

Purpose: Optimal primary febrile neutropenia (FN) prophylaxis (i.e. ciprofloxacin or granulocyte-colony stimulating factors [G-CSF]) for patients receiving docetaxel-cyclophosphamide (TC) chemotherapy is unknown. We assessed the feasibility of using a novel pragmatic comparative effectiveness trial to compare these standard-of-care options.Methods: Early-stage breast cancer patients receiving TC chemotherapy were randomised to either ciprofloxacin or G-CSF. Trial methodology consists of broad eligibility criteria, simply-defined endpoints, integrated consent model incorporating oral consent, and web-based randomisation in the clinic. Primary feasibility endpoints included patient and physician engagement (if > 50% of patients approached agree to participate and if > 50% of physicians approached patients for the study). Secondary clinical endpoints included the following: first occurrence rates of FN, treatment-related hospitalisation, or chemotherapy dose reduction/delay/discontinuation, as well as patient satisfaction with the oral consent process.Results: Of 204 patients approached, 91.2% (186/204) agreed to randomisation. Sixteen of twenty (80%) participating medical oncologists randomised patients. Median patient age was 57.7 (range 31.8-84.1). The 186 patients received 557 cycles of chemotherapy. Overall incidences of first events by patient (n = 186) were as follows: FN (18/186, 21.43%), treatment-related hospitalisation (11/186, 13.10%), chemotherapy reduction (19/186, 22.62%), chemotherapy discontinuation (16/186, 19.05%), and chemotherapy delays (5/186, 5.95%). A total of 37.77% (69/186) of patients and 12.39% (69/557) of chemotherapy cycles had at least one of these first events. Patients were highly satisfied with the oral consent process.Conclusion: This study met its feasibility endpoints. This model offers a means of comparing standard-of-care treatments in a practical and cost-efficient manner.Trial Registration: Trial registration: ClinicalTrials.gov : NCT02173262. [ABSTRACT FROM AUTHOR]

Background: Palliative care (PC) and psychosocial care (PSC) are essential services, which can positively impact on quality of life in patients with metastatic lung cancer, when advanced disease and poor prognosis preclude the use of curative therapies. The aims of this study were to describe patterns of PC and PSC and identify factors associated with service utilisation and overall patient survival.Method: A retrospective Australian cohort of South Western Sydney residents with newly diagnosed stage IV non-small cell lung cancer (NSCLC) in 2006-2012 was identified from the Local Health District Clinical Cancer Registry. Supplemental information was sourced from the area PC database and hospital medical records. Cox regression models with robust variance identified factors associated with PC and PSC and examined patient survival.Results: A total of 923 patients were identified. Eighty-three per cent of patients were seen by PC, with 67% seen within 8 weeks of diagnosis. PSC utilisation was 82%. Radiotherapy treatment and residential area were associated with both PC and PSC. Increasing age was associated with early PC referral. Median overall survival was 4 months. PC was associated with patient survival; however, the effect varied over time.Conclusion: The rate of PC and PSC in our metastatic NSCLC population was high when compared with published data. Despite this, there were gaps in PC and PSC provision in this population, notably with patients not receiving active treatment, and those receiving systemic therapy utilising these services less frequently. PSC and PC contact were not convincingly associated with improved patient survival. [ABSTRACT FROM AUTHOR]

Purpose: Effective symptom discussion is an essential step to enhance symptom management in patients with advanced pancreatic cancer (APC). However, little is known about how these patients communicate their symptoms during health encounters. The purpose of this study was to develop a typology to describe patterns of interactions between patients with APC, their caregivers, and healthcare providers as regards to symptoms and symptom management.Methods: Thematic analysis was used to analyze 37 transcripts of audio-recorded, naturally occurring encounters among APC patients, caregivers, and healthcare providers. Transcripts were drawn from the Values and Options in Cancer Care study, a larger randomized controlled communication and decision-making intervention trial, which recruited advanced cancer patients and caregivers across the USA. All transcripts from APC patients that were pre-intervention were analyzed.Results: Eight unique types of interaction patterns among patients, caregivers, and healthcare providers were identified as follows: collaborative interactions, explanatory interactions, agentic interactions, checklist interactions, cross-purpose interactions, empathic interactions, admonishing interactions, and diverging interactions.Conclusions: Our findings provide a systematic description of a variety of types of interaction patterns regarding symptom discussion among APC patients, caregivers, and healthcare providers. These typologies can be used to facilitate effective communication and symptom management. [ABSTRACT FROM AUTHOR]

Purpose: This case-control study was designed to assess the efficacy of cryotherapy to prevent paclitaxel-induced painful peripheral neuropathy in women with breast cancer.Methods: Participants served as their own paired control, with randomization of the cooled glove/sock to either the dominant or the non-dominant hand/foot, worn for 15 min prior to, during, and 15 min after completion of the paclitaxel infusion. Outcome measures included the Neuropathic Pain Symptom Inventory, the Brief Pain Inventory, and quantitative sensory testing. Data were measured at each of six time points-baseline, post-treatment (approximately 2 weeks after the last paclitaxel infusion), and at the first, fifth, ninth, and final weekly paclitaxel treatments.Results: Of 29 randomized participants, 20 (69%) received at least one cryotherapy treatment, and 11 (38%) received all four cryotherapy treatments. Ten (34%) participants could not tolerate the cryotherapy, and six (21%) declined further participation at some point during the trial. Only seven participants (24%) were available for the final post-chemotherapy QST and questionnaires. There were no significant differences in measures of neuropathy or pain between treated and untreated hands or feet.Conclusions: Strategies to prevent painful peripheral neuropathy are urgently needed. In this current trial, dropout due to discomfort precluded adequate power to fully understand the potential benefits of cryotherapy. Much more research is needed to discover safe and effective preventive strategies that can be easily implemented within busy infusion centers. [ABSTRACT FROM AUTHOR]

Purpose: Previous studies have underlined the benefits of exercise during cancer therapy. However, patients are insufficiently active during treatment. Telehealth is used to encourage people to be active, reducing difficulties and offsetting the lack of infrastructure often reported. We aimed to identify the effects of recommendations and telehealth on the level of physical activity, fatigue, and quality of life.Methods: Sixty patients suffering from various cancers under treatment were randomized into two groups. Every Sunday, they had to complete online questionnaires: number of steps, MFI-20, and EORTC-QLQ-30. Group R (recommendations) was given encouragement to improve physical activity during 8 weeks, using a recommendation guide, and received a weekly SMS text message for exercise promotion. Group C, without recommendations, was the control group.Results: Two-way ANOVAs for repeated measures did not reveal effect on the number of steps walked over time; however, the results indicated a beneficial effect for group R related to self-reported fatigue (F = 2.686, p = .01) and quality of life (F = 2.431, p = .02).Conclusion: Surprisingly, the level of exercise in group R did not significantly increase, but self-reported fatigue and quality of life were improved. This study underlines that inexpensive sharing of time, human, and financial means, through a protocol of physical activity, improves patient health. [ABSTRACT FROM AUTHOR]

Introduction: Cancer treatment-induced bone loss (CTIBL) is a long-term side effect of breast cancer therapy. Both calcitriol and weight-bearing exercise improve bone metabolism for osteoporotic patients, but are unproven in a breast cancer population. We used a novel high-dose calcitriol regimen with an individualized exercise intervention to improve bone metabolism in breast cancer survivors.Methods: We accrued 41 subjects to this open label, 2 × 2 factorial, randomized feasibility trial. Breast cancer survivors were randomized to receive the following: (1) calcitriol (45 micrograms/week), (2) individualized exercise with progressive walking and resistance training, (3) both, or (4) a daily multivitamin (control condition) for 12 weeks. Primary outcomes included changes in biomarkers of bone formation, bone resorption, and the bone remodeling index, a composite measure of bone formation and resorption. Safety measures included clinical and biochemical adverse events. A main effect analysis was used for these endpoints.Results: Hypercalcemia was limited to three grade I cases with no grade ≥ 2 cases. Among exercisers, 100% engaged in the prescribed aerobic training and 44.4% engaged in the prescribed resistance training. Calcitriol significantly improved bone formation (Cohen's d = 0.64; p < 0.01), resulting in a non-significant increase in the bone remodeling index (Cohen's d = 0.21; p = 31). Exercise failed to improve any of the bone biomarkers.Conclusions: Both calcitriol and exercise were shown to be feasible and well tolerated. Calcitriol significantly improved bone formation, resulting in a net increase of bone metabolism. Compliance with the exercise intervention was sub-optimal, which may have led to a lack of effect of exercise on bone metabolism. [ABSTRACT FROM AUTHOR]