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Background: Chemotherapy-induced nausea and vomiting (CINV) are major adverse effects of cancer chemotherapy. This study investigated: (1) the impact of CINV on patients' health-related quality of life (HRQL) in daily clinical practice; (2) the association between patient characteristics and type of antiemetics and CINV; and (3) the role of CINV in physicians' decisions to modify antiemetic treatment.Patients and Methods: This prospective, multicenter study was conducted in nine general hospitals in the Netherlands. During three consecutive chemotherapy cycles, patients used a diary to record episodes of nausea, vomiting and antiemetic use. For each cycle, these ratings were made 1 day prior to and 7 days after having received chemotherapy. The influence of CINV on patients' HRQL was evaluated with the Functional Living Index-Emesis (FLIE) questionnaire at day 6 of each treatment cycle. (Changes in) antiemetic use were recorded by the treating nurse. Patient inclusion took place between May 2005 and May 2007.Results: Two hundred seventy-seven patients were enrolled in the study. Acute and delayed nausea during the first treatment cycle was reported by 39% and 68% of the patients, respectively. The comparable figures for acute and delayed vomiting were 12% and 23%. During the first and subsequent treatment cycle, approximately one-third of the patients indicated that CINV had a substantial impact on their daily lives. Female patients and younger patients reported significantly more CINV than male and older patients. At all treatment cycles, patients receiving treatment with moderately emetogenic chemotherapy, containing anthracycline, reported more acute nausea than patients receiving highly emetogenic chemotherapy. Acute vomiting was associated significantly with change in (i.e., additional) antiemetic treatment. Delayed CINV did not influence antiemetic treatment.Conclusion: CINV continues to be a problem that adversely affects the daily lives of patients. CINV is worse in women and in younger patients. In daily clinical practice, acute CINV, but not delayed CINV, results in changes in antiemetic treatment. In view of the effects of not only acute, but also delayed CINV on daily life, more attention should be paid to adjustment of antiemetic treatment to cover CINV complaints, later during the chemotherapy cycle. [ABSTRACT FROM AUTHOR]

Purpose. This cross-sectional study investigated the degree of association between the results of ambulatory step activity monitoring (SAM), self-reported physical functioning (SRPF) and the 6-minute standardised walking test (6-MWT) in cancer patients with haematological malignancies. Method. Assessments of ambulatory SAM, SRPF and 6-MWT were assessed in 102 patients up to 122 days (mean 78 ± 35) after haematopoietic stem cell transplantation (HSCT). To determine the association between measures of walking, the Pearson product moment correlation coefficient ( r) including the 95%CI and the r2 were calculated. Simple linear regression analyses were performed to estimate the ambulatory step activity from SRPF and the 6-MWT. Results. The average age was 47 years (±12) and body mass index 23.4 (±4). The correlations were low between ambulatory SAM outputs and SRPF (ranging from −0.32 to 0.34, p < 0.01), and very low between SAM outputs and 6-MWT, (ranging from 0.21 to 0.24). The correlation between SRPF and the 6-MWT was low (0.33, p < 0.01). The correlation between SRPF and the 6-MWT was low (0.33, p < 0.01). The 95%CIs were quite narrow around r. The shared variance ( r2) between the SAM and SPPF ranged between 4% and 11% and the shared variance between the SAM and 6-MWT ranged between 0.5% and 18%. Linear regression yielded weak relationships and large standard errors of estimate between the SAM, SRPF and 6-MWT. Conclusions. SRPF and the 6-MWT do not reflect daily walking activity. In clinical use (e.g. to evaluate the effects of a rehabilitation program), ambulatory step activity outputs can be considered an additional outcome to assess day-to-day walking activity in patients with haematological cancer after HSCT. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To translate and validate the 'Sinhala' language version of the European Organization for Research and Treatment of Cancer head-and-neck cancer-specific health-related quality-of-life questionnaire module, the QLQ-H&N35, for use in Sri Lanka. METHODS: Psychometric testing assessed the hypothesized scale structure, scale reliability, construct validity and acceptability of the translated version of the QLQ-H&N35 in a consecutive series of 196 newly diagnosed head-and-neck cancer patients, recruited from tertiary-care oncology treatment centres in Sri Lanka. RESULTS: Compliance was high (97.5%), although nearly 40% of patients required assistance with completion of the questionnaire. Twenty-four sexually inactive patients declined to answer one or both items of the sexuality scale. Multi-trait scaling confirmed the overall scale structure, with good item-convergent (100%) and -discriminant (93.8%) validity, and scaling success (86.8%) rates. Cronbach's alpha coefficients exceeded 0.70 for all scales, except problems with sexuality (0.60) and problems with senses (0.61), which also evidenced a lower scaling success rate (50%). Confirmation of construct validity included satisfactory results for inter-scale correlations and known-groups comparisons for most scales; most correlations were statistically significant (p<0.01), with conceptually related scales showing relatively higher correlation. Most scale scores were able to discriminate clearly between pre- and current treatment patients. CONCLUSIONS: Results of the study provide strong support for the psychometric robustness of the 'Sinhala' version of the QLQ-H&N35. It may be advisable to interpret the two items assessing sensory problems separately, and to elicit information on sexuality from only those who are sexually active. [ABSTRACT FROM AUTHOR]

Diagnostic tests are now available that allow genetic testing for several types of cancer. The aim of genetic counseling and testing for cancer is to educate individuals about cancer risk and cancer prevention, which it is hoped will lead to a reduction in morbidity and mortality. However, at this relatively early stage in the development of genetic counseling and testing programs, information is needed on the psychosocial impact of such programs on both the individual counselee and his/her family. This paper reviews the findings obtained during the past decade on the uptake of genetic testing, reasons for undergoing genetic testing, and the impact of genetic counseling and testing on feelings of distress and guilt. Specific attention is paid to experiences with prophylactic mastectomy and oophorectomy and the effectiveness of the uptake of and satisfaction with these risk-reducing procedures. In addition, the possible impact of genetic testing on insurance, work and future plans is discussed. Suggestions are given for translating research findings into psychosocial services and future research efforts. [ABSTRACT FROM AUTHOR]

Quality of Life (QL) is becoming an increasingly popular endpoint in phase III cancer clinical trials. However, there is still no agreement as to what is the optimal approach to analysis. In this paper we review some concepts which should be considered during a QL analysis. We present two modelling approaches that have been substantively developed in other research fields: selection models and pattern-mixture models. These models are compared using data from an EORTC clinical trial in poor-prognosis prostate cancer patients. It is illustrated that, although selection models and pattern mixture are probabilistically equivalent, they may shed completely different light on data from a modeller's point of view. [ABSTRACT FROM AUTHOR]

Context: Improving health-related quality of life (HRQL) is an important goal of palliative treatment, but little is known about actual patient-physician communication regarding HRQL topics during palliative treatment.Objectives: To investigate the content of routine communication regarding 4 specific HRQL issues between oncologists and their patients and to identify patient-, physician-, and visit-specific factors significantly associated with discussion of such issues.Design: Observational study conducted between June 1996 and January 1998.Setting: Outpatient palliative chemotherapy clinic of a cancer hospital in the Netherlands.Participants: Ten oncologists and 240 of their patients (72% female; mean age, 55 years) who had incurable cancer and were receiving outpatient palliative chemotherapy.Main Outcome Measures: Patient and physician questionnaires and audiotape analysis of communication regarding daily activities, emotional functioning, pain, and fatigue during an outpatient consultation using the Roter Interaction Analysis System.Results: Physicians devoted 64% of their conversation to medical/technical issues and 23% to HRQL issues. Patients' communication behavior was divided more equally between medical/technical issues (41%) and HRQL topics (48%). Of the independent variables investigated, patients' self-reported HRQL was the most powerful predictor of discussing HRQL issues. Nevertheless, in 20% to 54% of the consultations in which patients were experiencing serious HRQL problems, no time was devoted to discussion of those problems. In particular, these patients' emotional functioning and fatigue were unaddressed 54% and 48% of the time, respectively. Discussion of HRQL issues was not more frequent in consultations in which tumor response was evaluated.Conclusion: Despite increasing recognition of the importance of maintaining patients' HRQL as a goal of palliative treatment, the amount of patient-physician communication devoted to such issues remains limited and appears to make only a modest contribution, at least in an explicit sense, to the evaluation of treatment efficacy in daily clinical practice. [ABSTRACT FROM AUTHOR]

Background: Differential item functioning (DIF) methods can be used to determine whether different subgroups respond differently to particular items within a health-related quality of life (HRQoL) subscale, after allowing for overall subgroup differences in that scale. This article reviews issues that arise when testing for DIF in HRQoL instruments. We focus on logistic regression methods, which are often used because of their efficiency, simplicity and ease of application.Methods: A review of logistic regression DIF analyses in HRQoL was undertaken. Methodological articles from other fields and using other DIF methods were also included if considered relevant.Results: There are many competing approaches for the conduct of DIF analyses and many criteria for determining what constitutes significant DIF. DIF in short scales, as commonly found in HRQL instruments, may be more difficult to interpret. Qualitative methods may aid interpretation of such DIF analyses.Conclusions: A number of methodological choices must be made when applying logistic regression for DIF analyses, and many of these affect the results. We provide recommendations based on reviewing the current evidence. Although the focus is on logistic regression, many of our results should be applicable to DIF analyses in general. There is a need for more empirical and theoretical work in this area. [ABSTRACT FROM AUTHOR]

Background: Premature menopause is a major concern of younger women undergoing adjuvant therapy for breast cancer. Hormone replacement therapy is contraindicated in women with a history of breast cancer. Non-hormonal medications show a range of bothersome side-effects. There is growing evidence that cognitive behavioral therapy (CBT) and physical exercise can have a positive impact on symptoms in naturally occurring menopause. The objective of this study is to investigate the efficacy of these interventions among women with breast cancer experiencing treatment-induced menopause.Methods/design: In a randomized, controlled, multicenter trial, we are evaluating the effectiveness of CBT/relaxation, of physical exercise and of these two program elements combined, in reducing menopausal symptoms, improving sexual functioning, reducing emotional distress, and in improving the health-related quality of life of younger breast cancer patients who experience treatment-induced menopause. 325 breast cancer patients (aged < 50) are being recruited from hospitals in the Amsterdam region, and randomly allocated to one of the three treatment groups or a 'waiting list' control group. Self-administered questionnaires are completed by the patients at baseline, and at 12 weeks (T1) and 6 months (T2) post-study entry. Upon completion of the study, women assigned to the control group will be given the choice of undergoing either the CBT or physical exercise program.Discussion: Cognitive behavioral therapy and physical exercise are potentially useful treatments among women with breast cancer undergoing treatment-induced, premature menopause. For these patients, hormonal and non-hormonal therapies are contraindicated or have a range of bothersome side-effects. Hence, research into these interventions is needed, before dissemination and implementation in the current health care system can take place. [ABSTRACT FROM AUTHOR]

BACKGROUND: Health-related quality of life (HRQOL) questionnaires should ideally be adapted to the individual patient and at the same time scores should be directly comparable across patients. This is achievable using a computerised adaptive test (CAT). Basing the CAT on an existing instrument enables measurement within an established HRQOL framework and allows backward-compatibility with studies using the original instrument. Because of these advantages the EORTC Quality of Life Group (QLG) has initiated a project to develop a CAT version of the widely used EORTC QLQ-C30. METHODS: We present the EORTC QLG's strategy for developing a CAT. For each dimension of the EORTC QLQ-C30 our approach includes literature search and conceptualisation, formulation of new items, expert and patient evaluations, field-testing, and psychometric analyses of the items. The strategy is illustrated with the initial results of the development of CAT for physical functioning (PF). RESULTS: We identified 975 PF items in the literature. Of these, 407 items were deemed relevant, i.e. measured one of the PF aspects measured by the QLQ-C30. Based on these items we developed 86 new items. Review by the EORTC CAT-project group reduced this to 66 items. Based on expert and patient evaluations several items were revised and the list was further reduced to 51 items. CONCLUSIONS: Based on the findings for PF, we believe that our approach will generate item pools that are relevant and appropriate for cancer patients. These will form the basis for a backward-compatible CAT assessing the HRQOL dimensions of the EORTC QLQ-C30. [ABSTRACT FROM AUTHOR]

AIMS: The psychometric properties of the EORTC QLQ-BN20, a brain cancer-specific HRQOL questionnaire, have been previously determined in an English-speaking sample of patients. This study examined the validity and reliability of the questionnaire in a multi-national, multi-lingual study. METHODS: QLQ-BN20 data were selected from two completed phase III EORTC/NCIC clinical trials in brain cancer (N=891), including 12 languages. Experimental treatments were surgery followed by radiotherapy (RT) and adjuvant PCV chemotherapy or surgery followed by concomitant RT plus temozolomide (TMZ) chemotherapy and adjuvant TMZ chemotherapy. Standard treatment consisted of surgery and postoperative RT alone. The psychometrics of the QLQ-BN20 were examined by means of multi-trait scaling analyses, reliability estimation, known groups validity testing, and responsiveness analysis. RESULTS: All QLQ-BN20 items correlated more strongly with their own scale (r>0.70) than with other QLQ-BN20 scales. Internal consistency reliability coefficients were high (all alpha0.70). Known-groups comparisons yielded positive results, with the QLQ-BN20 distinguishing between patients with differing levels of performance status and mental functioning. Responsiveness of the questionnaire to changes over time was acceptable. CONCLUSION: The QLQ-BN20 demonstrates adequate psychometric properties and can be recommended for use in conjunction with the QLQ-C30 in assessing the HRQOL of brain cancer patients in international studies. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To obtain consent from breast cancer survivors to use residual tissue for a study on carriership of germ line mutations in the BRCA 1 and 2 genes. To investigate which consent regimen patients prefer for research with archived tissue. PARTICIPANTS: One hundred and thirty-two patients surgically treated for breast cancer between 1995 and 1997 in the Netherlands Cancer Institute were mailed a consent form and a questionnaire. RESULTS: A consent form was obtained from 90%; 3% withheld consent for the use of archived tissue. A completed questionnaire was returned by 84%. 'One-time general consent' was considered to be the best procedure for consenting to research with stored tissue by 56%, 23% favoured the current 'opt-out' procedure; 21% did not know or had no preference. CONCLUSION: Obtaining fresh consent for genetic research with stored tissue is possible at the cost of time and effort. Most patients give consent for research with residual tissue. [ABSTRACT FROM AUTHOR]

The systematic integration of quality-of-life (QOL) assessment into the clinical setting, although deemed important, infrequently occurs. Barriers include the need for a practical approach perceived as useful and efficient by patients and clinicians and the inability of clinicians to readily identify the value of integrating QOL assessments into the clinical setting. We discuss the use of QOL data in patient care and review approaches used to integrate QOL assessment into the clinical setting. Additionally, we highlight select QOL measures that have been successfully applied in the clinical setting. These measures have been shown to identify key QOL issues, improve patient-clinician communications, and improve and enhance patient care. However, the work done to date requires continued development. Continued research is needed that provides information about benefits and addresses limitations of current approaches. [ABSTRACT FROM AUTHOR]

This study describes the quality of life (QoL) of long-term Hodgkin's lymphoma survivors and compares it to an age-matched normative sample. The population-based Eindhoven Cancer Registry was used to select all patients diagnosed with Hodgkin's lymphoma from 1989 to 1998. Eighty percent of survivors completed the SF-36 and the quality of life-cancer survivors questionnaire. QoL was better among patients diagnosed 10-15 years ago compared to patients diagnosed 5-9 years ago. The patients diagnosed 5-9 years ago experienced lower general health, social functioning, mental health and vitality compared to an age-matched normative sample, while the patients diagnosed 10-15 years earlier reported lower general health but better physical functioning. Most patients reported that their work situation did not change. Problems pertaining to the obtainment of health insurance, life insurance and mortgages were high. QoL among Hodgkin's lymphoma survivors is lower compared to an age-matched normative sample. Survivors furthermore experience some (financial) problems in the years after diagnosis. [ABSTRACT FROM AUTHOR]

Background: Neurocognitive impairments are common in patients with a brain tumour, and may negatively impact on functioning in daily life, particularly on instrumental activities of daily living (IADL). The EORTC IADL-BN32 questionnaire was developed to measure IADL in this patient population., Methods: In this international validation study, we evaluated the EORTC IADL-BN32 questionnaire on several psychometric properties in a large sample of patients with a primary or metastatic brain tumour. We administered the 32-item questionnaire three times: at 'baseline', after 2 weeks and after 3 months. Procedures were in accordance with EORTC Quality of Life Group module development guidelines., Results: In total, 326 patients participated in the study. A bifactor scale structure showed satisfactory model fit measures, with five multi-item scales and two single items, and an IADL sum score. The internal consistency of the multi-item scales ranged from good to excellent (range Cronbach's α: 0.86-0.97). We found significant differences in scale scores between patients with and without neurocognitive impairments or complaints, supporting the construct validity. Initial cross-cultural validity analyses showed indications of item response biases for certain items. Analyses indicated moderate to good test-retest agreement (intraclass correlation coefficient > 0.70) between baseline and the 2-week follow-up assessment for all but one scale. Deterioration of EORTC IADL-BN32 scale scores were consistent with clinically relevant deterioration on other functional measures with small to large effect sizes, however, subgroup sample sizes were small., Conclusion: Overall, the EORTC IADL-BN32 questionnaire exhibited adequate to excellent psychometric properties. Cross-cultural validity and responsiveness should be further explored., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Purpose: This individual participant data meta-analysis (IPD-MA) assesses exercise effects on self-reported cognitive functioning (CF) and investigates whether effects differ by patient-, intervention-, and exercise-related characteristics., Methods: IPD from 16 exercise RCTs, including 1987 patients across multiple types of non-metastatic cancer, was pooled. A one-stage IPD-MA using linear mixed-effect models was performed to assess exercise effects on self-reported CF (z-score) and to identify whether the effect was moderated by sociodemographic, clinical, intervention- and exercise-related characteristics, or fatigue, depression, anxiety, and self-reported CF levels at start of the intervention (i.e., baseline). Models were adjusted for baseline CF and included a random intercept at study level to account for clustering of patients within studies. A sensitivity analysis was performed in patients who reported cognitive problems at baseline., Results: Minimal significant beneficial exercise effects on self-reported CF (β=-0.09 [-0.16; -0.02]) were observed, with slightly larger effects when the intervention was delivered post-treatment (n=745, β=-0.13 [-0.24; -0.02]), and no significant effect during cancer treatment (n=1,162, β=-0.08 [-0.18; 0.02]). Larger effects were observed in interventions of 12 weeks or shorter (β=-0.14 [-0.25; -0.04]) or 24 weeks or longer (β=-0.18 [-0.32; -0.02]), whereas no effects were observed in interventions of 12-24 weeks (β=0.01 [-0.13; 0.15]). Exercise interventions were most beneficial when provided to patients without anxiety symptoms (β=-0.10 [-0.19; -0.02]) or after completion of treatment in patients with cognitive problems (β=-0.19 [-0.31; -0.06]). No other significant moderators were identified., Conclusions: This cross-cancer IPD meta-analysis observed small beneficial exercise effects on self-reported CF when the intervention was delivered post-treatment, especially in patients who reported cognitive problems at baseline., Implications for Cancer Survivors: This study provides some evidence to support the prescription of exercise to improve cognitive functioning. Sufficiently powered trials are warranted to make more definitive recommendations and include these in the exercise guidelines for cancer survivors., (© 2023. The Author(s).)

Physical exercise both during and after curative cancer treatment has been shown to reduce side effects. Evidence in the metastatic cancer setting is scarce, and interventions that improve health-related quality of life (HRQOL) are much needed for patients with metastatic breast cancer (MBC). The multinational randomized controlled PREFERABLE-EFFECT trial assessed the effects of exercise on fatigue and HRQOL in patients with MBC. In total, 357 patients with MBC and a life expectancy of ≥6 months but without unstable bone metastases were recruited at eight study centers across five European countries and Australia. Participants were randomly assigned (1:1) to usual care (control group, n = 179) or a 9-month supervised exercise program (exercise group, n = 178). Intervention effects on physical fatigue (European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-FA12 scale) and HRQOL (EORTC QLQ-C30 summary score) were determined by comparing the change from baseline to 3, 6 (primary timepoint) and 9 months between groups using mixed models for repeated measures, adjusted for baseline values of the outcome, line of treatment (first or second versus third or higher) and study center. Exercise resulted in significant positive effects on both primary outcomes. Physical fatigue was significantly lower (-5.3 (95% confidence interval (CI), -10.0 to -0.6), Bonferroni-Holm-adjusted P = 0.027; Cohen's effect size, 0.22) and HRQOL significantly higher (4.8 (95% CI, 2.2-7.4), Bonferroni-Holm-adjusted P = 0.0003; effect size, 0.33) in the exercise group than in the control group at 6 months. Two serious adverse events occurred (that is, fractures), but both were not related to bone metastases. These results demonstrate that supervised exercise has positive effects on physical fatigue and HRQOL in patients with MBC and should be recommended as part of supportive care.ClinicalTrials.gov Identifier: NCT04120298 ., (© 2024. The Author(s).)

Objectives: To report the long-term outcomes from a longitudinal psychosocial study that forms part of the 'Identification of Men with a genetic predisposition to ProstAte Cancer: Targeted Screening in men at higher genetic risk and controls' (IMPACT) study. The IMPACT study is a multi-national study of targeted prostate cancer (PrCa) screening in individuals with a known germline pathogenic variant (GPV) in either the BReast CAncer gene 1 (BRCA1) or the BReast CAncer gene 2 (BRCA2)., Subjects and Methods: Participants enrolled in the IMPACT study were invited to complete a psychosocial questionnaire prior to each annual screening visit for a minimum of 5 years. The questionnaire included questions on sociodemographics and the following measures: Hospital Anxiety and Depression Scale, Impact of Event Scale, 36-item Short-Form Health Survey, Memorial Anxiety Scale for PrCa, Cancer Worry Scale, risk perception and knowledge., Results: A total of 760 participants completed questionnaires: 207 participants with GPV in BRCA1, 265 with GPV in BRCA2 and 288 controls (non-carriers from families with a known GPV). We found no evidence of clinically concerning levels of general or cancer-specific distress or poor health-related quality of life in the cohort as a whole. Individuals in the control group had significantly less worry about PrCa compared with the carriers; however, all mean scores were low and within reported general population norms, where available. BRCA2 carriers with previously high prostate-specific antigen (PSA) levels experience a small but significant increase in PrCa anxiety (P = 0.01) and PSA-specific anxiety (P < 0.001). Cancer risk perceptions reflected information provided during genetic counselling and participants had good levels of knowledge, although this declined over time., Conclusion: This is the first study to report the longitudinal psychosocial impact of a targeted PrCa screening programme for BRCA1 and BRCA2 carriers. The results reassure that an annual PSA-based screening programme does not have an adverse impact on psychosocial health or health-related quality of life in these higher-risk individuals. These results are important as more PrCa screening is targeted to higher-risk groups., (© 2024 The Author(s). BJU International published by John Wiley & Sons Ltd on behalf of BJU International.)

Purpose: Numerous randomized controlled trials (RCTs) have shown beneficial exercise effects on fatigue, anxiety and depression and health-related quality of life (HRQoL) in breast cancer (BC) patients during and shortly after treatment. Here, we investigated the long-term effects of exercise during chemotherapy for BC on these outcomes., Methods: We invited participants of two highly comparable RCTs that investigated the effects of exercise (EX) (versus usual care (UC)) during chemotherapy in patients with non-metastatic BC (N = 357) to participate in an 8-year follow-up. In both trials, fatigue, anxiety and depression and HRQoL were assessed using the same questionnaires, at multiple timepoints. Linear mixed-effect models were used to compare study arms over time., Results: In total, 156 participants (EX = 82; UC = 74) completed the follow-up questionnaires. EX reported comparable general (between-group difference 0.73, 95% confidence interval (- 0.35; 1.80), ES = 0.18) and physical fatigue (0.55 (- 0.55; 1.65), ES = 0.13), small but statistically significantly higher levels of anxiety (1.24 (0.47 to 2.00), ES = 0.39) and depression (1.10 (0.34; 1.85), ES = 0.38), significantly lower global HRQoL (- 5.99 (- 10.65; - 1.32), ES = 0.34) and comparable summary HRQoL (- 1.90 (- 4.70; 0.89), ES = 0.16) compared to UC., Conclusion: No long-term beneficial effects of exercise during chemotherapy on BC patients' fatigue, anxiety, depression or HRQoL were observed. The less favourable outcomes for mood and HRQoL that were observed 8 years after participation in an exercise intervention may be explained by selective loss-to-follow-up., Implications for Cancer Survivors: The results highlight the need to incorporate strategies that promote physical activity maintenance after participation in an exercise programme to also counteract long-term detrimental side effects of cancer treatment., (© 2024. The Author(s).)

Importance: Online symptom monitoring through patient-reported outcomes can enhance health-related quality of life and survival. However, widespread adoption in clinical care remains limited due to various barriers including the need to reduce health care practitioners' workload., Objective: To report the effects of patient-reported outcome (PRO) symptom monitoring on HRQOL and survival up to 1 year after initiation of any treatment in patients with lung cancer., Design, Setting, and Participants: SYMPRO-Lung is a multicenter stepped-wedge cluster randomized trial including patients with stage I to IV lung cancer. The inclusion period was from October 24, 2019, until September 16, 2021, and data collection ended October 8, 2022. Data analysis was conducted from November 9, 2023, until March 18, 2024., Intervention: Patients in the intervention group reported PRO symptoms weekly using the Patient Reported Outcomes version of the Common Toxicity Criteria for Adverse Events lung cancer subset. If symptoms exceeded a validated threshold, an alert was sent to the health care practitioner (active intervention subgroup) or to the patient (reactive intervention subgroup). Patients in the control group received standard care., Main Outcomes and Measures: Health-related quality of life was measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire at baseline, 15 weeks (T1), 6 months (T2), and 1 year (T3), with the summary score (SS) and physical functioning (PF) as primary end points. Linear mixed-effects modeling was used to assess mean differences over time. Effect size (ES) of 0.40 or greater was considered clinically relevant. Cox proportional hazards regression survival analyses were performed to estimate the effect of the intervention on progression-free survival and overall survival (OS). Data were analyzed on an intention-to-treat basis., Results: A total of 515 patients (266 [51.7%] men; mean [SD] age, 65.4 [9.4] years) were included in the study (266 in the control group; 249 in the pooled intervention group). Most baseline characteristics were balanced between groups; however, the most notable exception was the distribution in cancer staging: the intervention group had a higher proportion of patients with stage IV cancer compared with the control group (139 [56%] vs 118 [44%]). The pooled intervention group had a significantly better SS (mean difference T1, 5.22; 95% CI, 2.72-7.73; P < .001; ES = 0.33; mean difference T2, 6.28; 95% CI, 3.65-8.92; P < .001; ES = 0.40; mean difference T3, 3.97; 95% CI, 1.15-6.80; P = .006; ES = 0.25) compared with the control group. Group differences improved more in PF but did not meet the ES greater than or equal to 0.40 threshold (mean difference T1, 7.00; 95% CI, 3.65-10.35; P < .001; ES = 0.27; mean difference T2, 6.79; 95% CI, 3.26-10.31; P < .001; ES = 0.26; mean difference T3, 5.01; 95% CI, 1.23-8.79; P = .009; ES = 0.19). No significant differences in HRQOL were observed between the reactive (n = 89) and active (n = 160) intervention groups. The HR for progression-free survival for the active intervention group compared with the control group was 0.78 (95% CI, 0.58-1.04); the finding was not statistically significant. The HR for overall survival for both interventions groups compared with the control group were not statistically significant.(active: HR, 0.80; 95% CI, 0.55-1.15; reactive: HR, 0.69; 95% CI, 0.42-1.15)., Conclusions and Relevance: In this 1-year follow-up of a stepped-wedge cluster randomized trial, PRO symptom monitoring yielded improvements in long-term HRQOL in patients with lung cancer. The reactive approach proved equally effective as the active approach. A nonsignificant potential survival benefit was observed for the intervention group. These positive results provide further evidence for the usefulness of routine PRO symptom monitoring in lung cancer care., Trial Registration: The Netherlands trial register Identifier: NL7897.

Purpose: To support the development and implementation of exercise programming for people with prostate cancer (PC), we investigated their views on exercise., Methods: Online survey with open recruitment. We collected data on clinical and sociodemographic variables, experiences with exercise advice, outcome expectations, and preferences. We explored determinants of (1) having been counselled about exercise and (2) preferring supervised exercise., Results: The survey was completed by 171 patients (mean age = 70 years, SD = 6.5) from all PC treatment pathways. Sixty-three percent of the respondents reported never having been informed about the potential benefits of exercise. Forty-nine percent preferred exercise to be supervised. Respondents generally reported a positive attitude towards exercise. Seventy-four percent indicated barriers to exercising, including fatigue and lack of access to specific programmes. Outcome expectations were generally positive but moderately strong. Receiving hormonal therapy and younger age were significantly associated with having received exercise advice. Being insured and having higher fatigue levels contributed significantly to the preference for supervised exercise., Conclusion: Dutch people with PC report receiving insufficient effective exercise counselling. Yet, they are open to exercise and expect exercise to improve their health, although they experience various barriers that limit their ability to exercise., Implications for Cancer Survivors: The moderate outcome expectations for exercise of people with PC and their limited recall of exercise counselling highlight the need for better integration of exercise in clinical pathways. The lack of access to specific programming limits the use of evidence-based exercise programmes for people with PC., (© 2023. The Author(s).)

Background: As a local treatment for prostate cancer (PCa), robot-assisted radical prostatectomy (RARP) may have a quality of life (QoL) benefit over open surgery. Recent analyses revealed substantial between-country differences in the function and symptom scale scores for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), which is typically used to assess patient-reported QoL. Such differences could have implications for multinational studies in PCa., Objective: To examine whether nationality is significantly associated with patient-reported QoL., Design, Setting, and Participants: The study cohort comprised Dutch and German patients with PCa treated with RARP in a single high-volume prostate center from 2006 to 2018. Analyses were restricted to patients who were preoperatively continent with at least one follow-up time point., Outcome Measurements and Statistical Analysis: QoL was measured in terms of the global Quality of Life (QL) scale score and the overall summary score for the EORTC QLQ-C30. Linear mixed models for repeated-measures multivariable analyses (MVAs) were used to examine the association between nationality and both the global QL score and the summary score. MVAs were further adjusted for QLQ-C30 baseline values, age, Charlson comorbidity index, preoperative prostate-specific antigen, surgical expertise, pathological tumor and nodal stage, Gleason grade, degree of nerve-sparing, surgical margin status, 30-d Clavien-Dindo grade complications, urinary continence recovery, and biochemical recurrence/postoperative radiotherapy., Results and Limitations: For Dutch (n = 1938) versus German (n = 6410) men, the mean baseline scores were 82.8 versus 71.9 for the global QL scale score and 93.4 versus 89.7 for the QLQ-C30 summary score. Urinary continence recovery (QL: +8.9, 95% confidence interval [CI] 8.1-9.8; p < 0001) and Dutch nationality (QL: +6.9, 95% CI 6.1-7.6; p < 0001) were the strongest positive contributors to the global QL and summary scores, respectively. The main limitation is the retrospective study design. In addition, our Dutch cohort may not be representative of the general Dutch population and reporting bias cannot be ruled out., Conclusions: Our findings provide observational evidence under specific conditions involving the same setting for patients of two different nationalities suggesting that cross-national patient-reported QoL differences appear to be real and may need to be taken into consideration in multinational studies., Patient Summary: We observed differences in the quality-of-life scores reported by Dutch and German patients with prostate cancer after they underwent robot-assisted removal of the prostate. These findings should be taken into consideration in cross-national studies., (Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Purpose: Cancer-related cognitive impairment (CRCI) following chemotherapy is commonly reported in breast cancer survivors, even years after treatment. Data from preclinical studies suggest that exercise during chemotherapy may prevent or diminish cognitive problems; however, clinical data are scarce., Methods: This is a pragmatic follow-up study of two original randomized trials, which compares breast cancer patients randomized to exercise during chemotherapy to non-exercise controls 8.5 years post-treatment. Cognitive outcomes include an online neuropsychological test battery and self-reported cognitive complaints. Cognitive performance was compared to normative data and expressed as age-adjusted z-scores., Results: A total of 143 patients participated in the online cognitive testing. Overall, cognitive performance was mildly impaired on some, but not all, cognitive domains, with no significant differences between groups. Clinically relevant cognitive impairment was present in 25% to 40% of all participants, regardless of study group. We observed no statistically significant effect of exercise, or being physically active during chemotherapy, on long-term cognitive performance or self-reported cognition, except for the task reaction time, which favored the control group (β = -2.04, 95% confidence interval: -38.48; -2.38). We observed no significant association between self-reported higher physical activity levels during chemotherapy or at follow-up and better cognitive outcomes., Conclusion: In this pragmatic follow-up study, exercising and being overall more physically active during or after adjuvant chemotherapy for breast cancer was not associated with better tested or self-reported cognitive functioning, on average, 8.5 years after treatment. Future prospective studies are needed to document the complex relationship between exercise and CRCI in cancer survivors., (© 2024. The Author(s).)

Introduction: The number of randomized controlled trials (RCTs) investigating the effects of exercise among cancer survivors has increased in recent years; however, participants dropping out of the trials are rarely described. The objective of the present study was to assess which combinations of participant and exercise program characteristics were associated with dropout from the exercise arms of RCTs among cancer survivors., Methods: This study used data collected in the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) study, an international database of RCTs investigating the effects of exercise among cancer survivors. Thirty-four exercise trials, with a total of 2467 patients without metastatic disease randomized to an exercise arm were included. Harmonized studies included a pre and a posttest, and participants were classified as dropouts when missing all assessments at the post-intervention test. Subgroups were identified with a conditional inference tree., Results: Overall, 9.6% of the participants dropped out. Five subgroups were identified in the conditional inference tree based on four significant associations with dropout. Most dropout was observed for participants with BMI >28.4 kg/m 2 , performing supervised resistance or unsupervised mixed exercise (19.8% dropout) or had low-medium education and performed aerobic or supervised mixed exercise (13.5%). The lowest dropout was found for participants with BMI >28.4 kg/m 2 and high education performing aerobic or supervised mixed exercise (5.1%), and participants with BMI ≤28.4 kg/m 2 exercising during (5.2%) or post (9.5%) treatment., Conclusions: There are several systematic differences between cancer survivors completing and dropping out from exercise trials, possibly affecting the external validity of exercise effects., (© 2024 The Authors. Scandinavian Journal of Medicine & Science In Sports published by John Wiley & Sons Ltd.)

Background: Previous studies using patient-reported outcomes measures (PROMs) to monitor symptoms during and after (lung) cancer treatment used alerts that were sent to the health-care provider, although an approach in which patients receive alerts could be more clinically feasible. The primary aim of this study was to compare the effect of weekly PROM symptom monitoring via a reactive approach (patient receives alert) or active approach (health-care provider receives alert) with care as usual on health-related quality of life (HRQOL) at 15 weeks after start of treatment in lung cancer patients., Methods: The SYMPRO-Lung trial is a multicenter randomized controlled trial using a stepped wedge design. Stage I-IV lung cancer patients in the reactive and active groups reported PROM symptoms weekly, which were linked to a common alerting algorithm. HRQOL was measured by the EORTC QLQ-C30 at baseline and after 15 weeks. Linear regression analyses and effect size estimates were used to assess mean QOL-C30 change scores between groups, accounting for confounding., Results: A total of 515 patients were included (160 active group, 89 reactive group, 266 control group). No differences in HRQOL were observed between the reactive and active group (summary score: unstandardized beta [B] = 0.51, 95% confidence interval [CI] = -3.22 to 4.24, Cohen d effect size [ES] = 0.06; physical functioning: B = 0.25, 95% CI = -5.15 to 4.64, ES = 0.02). The combined intervention groups had statistically and clinically significantly better mean change scores on the summary score (B = 4.85, 95% CI = 1.96 to 7.73, ES = 0.57) and physical functioning (B = 7.00, 95% CI = 2.90 to 11.09, ES = 0.71) compared with the control group., Conclusions: Weekly PRO symptom monitoring statistically and clinically significantly improves HRQOL in lung cancer patients. The logistically less intensive, reactive approach may be a better fit for implementation., (© The Author(s) 2023. Published by Oxford University Press.)

Background: To successfully implement exercise programs for patients with metastatic breast cancer (MBC), services and patient education should consider patients' knowledge, preferences, values, and goals. Hence, gaining insight into their perspectives on exercise and exercise programming is important., Method: In this cross-sectional survey, we recruited patients with MBC from the Netherlands, Germany, Poland, Spain, and Sweden. We collected data on patients' knowledge and skills about exercise and outcome expectations. We identified barriers to and facilitators of participation in exercise programs, and patients' preferences for program content and modes of exercise delivery., Results: A total of 420 patients participated in the survey. Respondents were, on average, 56.5 years old (SD 10.8) and 70% had bone metastases. Sixty-eight percent reported sufficient skills to engage in aerobic exercise, but only 35% did so for resistance exercise. Respondents expected exercise to have multiple physical benefits, but a few patients expected exercise to worsen their pain (5%). Not having access to an exercise program for cancer patients (27%), feeling too tired (23%), and/or weak (23%) were the most often reported barriers. Facilitators for exercising regularly were previous positive physical (72%) and emotional (68%) experiences with exercising, and receiving personalized advice from a physiotherapist or sport/fitness instructor (62%). Patients were most interested in walking and preferred exercising at a public gym, although there were differences by country. Fifty-seven percent did not know whether their insurance company reimburses exercise programs and only 9% would be willing to pay more than €50 per month to participate., Conclusion: A large percentage of patients with MBC lack the skills to engage in regular exercise as recommended by exercise guidelines for people with cancer. Patients may benefit from personalized advice and appropriate training facilities to overcome barriers. When implementing exercise interventions, attention should be given to reimbursement and the relatively low willingness-to-pay., (© 2023. The Author(s).)

Objective: Risk-reducing salpingo-oophorectomy (RRSO) is advised before 40-45 years of age for BRCA1/2 mutation carriers. This study describes the effect of RRSO on lipid determinants, hemoglobin A1c (HbA1c) and C-reactive protein (CRP)., Methods: A total of 142 women with increased risk of ovarian cancer were included, 92 premenopausal and 50 postmenopausal. Serum levels of low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol and total cholesterol, triglycerides, HbA1c and CRP were determined at three points in time: before (T0) and 6 weeks (T1) and 7 months (T2) following RRSO. The Hot Flush Rating Scale was administered at the same time points., Results: In premenopausal women, levels of HDL-cholesterol, the cholesterol ratio and HBA1c increased significantly over time, although still staying within the reference range. In this group, hot flushes increased over time ( p  < 0.001). In postmenopausal women, no significant changes were observed following RRSO. At T2, serum LDL-cholesterol, triglycerides, HbA1c and CRP were significantly lower in premenopausal women compared to postmenopausal women, whereas HDL was increased., Conclusions: Seven months after RRSO, the lipid profile in premenopausal women had changed, although still staying within the reference range. For postmenopausal women, we did not observe any significant changes. Our results do not suggest a worsening of cardiovascular risk within 7 months of RRSO.

Objectives: To apply the estimand framework in time to deterioration (TTD) analysis of patient-reported outcomes (PROs), and identify the appropriate statistical methods to deal with intercurrent event (IEs) such as death., Study Design and Setting: Data from phase II randomized trial were used. We estimated TTD using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 questionnaire with death as the IE, by applying Kaplan-Meier (K.M.) estimator and Cox proportional hazards (PH) model. The Fine-Gray approach was explored, accounting for death as a competing risk. The estimands targeted by the aforementioned methods were defined., Results: We analyzed the data of 64 patients with available questionnaires at baseline. The most notable differences in TTD estimates were observed for deterioration in physical functioning: the hazard ratios were 0.44 [95% CI 0.22-0.90] and 0.62 [95% CI 0.36-1.07] by either ignoring death (31 events) or considering it as deterioration (58 events), respectively (Cox-PH model). When considering death as a competing event (Fine-Gray model), the sub-HRs was 0.51 [95% CI 0.26-1.01]., Conclusion: Depending on the proportion and distribution of deaths occurring before deterioration between arms, the Fine-Gray competing risks model should be considered rather than KM estimator and Cox PH model to reflect the patient's experience of the disease and treatment burden., Competing Interests: Declaration of competing interest AA received honorary from Astrazeneca, AMGEN, IPSEN, Kite/Gilead, and had a advisory role for Astrazeneca and Kite/Gilead, outside the submitted work. CL received honorary from MSD, Amgen, Roche, Servier, and travel expenses from Roche and MSD, outside the submitted work. JBB received honorary from Amgen, AstraZeneca, Bayer, Merck Serono, Pierre Fabre, Roche, Sanofi, Servier, Viatris and has a advisory role for Amgen, Acobiom, BMS, GSK, Merck Serono, MSD, Servier, Pierre Fabre, Incyte, outside the submitted work. FE had a consultancy or advisory role for AbbVie, Incyte, Janssen, Novartis, and Syros, outside the submitted work. Other authors have no conflict of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: Animal data suggest that exercise during chemotherapy is cardioprotective, but clinical evidence to support this is limited. This study evaluated the effect of exercise during chemotherapy for breast cancer on long-term cardiovascular toxicity., Methods: This is a follow-up study of two previously performed randomised trials in patients with breast cancer allocated to exercise during chemotherapy or non-exercise controls. Cardiac imaging parameters, including T1 mapping (native T1, extracellular volume fraction (ECV)), left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS), cardiorespiratory fitness, and physical activity levels, were acquired 8.5 years post-treatment., Results: In total, 185 breast cancer survivors were included (mean age 58.9±7.8 years), of whom 99% and 18% were treated with anthracyclines and trastuzumab, respectively. ECV and Native T1 were 25.3%±2.5% and 1026±51 ms in the control group, and 24.6%±2.8% and 1007±44 ms in the exercise group, respectively. LVEF was borderline normal in both groups, with an LVEF<50% prevalence of 22.5% (n=40/178) in all participants. Compared with control, native T1 was statistically significantly lower in the exercise group (β=-20.16, 95% CI -35.35 to -4.97). We found no effect of exercise on ECV (β=-0.69, 95% CI -1.62 to 0.25), LVEF (β=-1.36, 95% CI -3.45 to 0.73) or GLS (β=0.31, 95% CI -0.76 to 1.37). Higher self-reported physical activity levels during chemotherapy were significantly associated with better native T1 and ECV., Conclusions: In long-term breast cancer survivors, exercise and being more physically active during chemotherapy were associated with better structural but not functional cardiac parameters. The high prevalence of cardiac dysfunction calls for additional research on cardioprotective measures, including alternative exercise regimens., Trial Registration Number: NTR7247., Competing Interests: Competing interests: GS reports institutional research support from AstraZeneca, Merck, Novartis, Roche and Seagen, Consultancy for Biovica. Other authors declare no conflict of interest., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)