[Treatment for an adjustment disorder after cancer: results of a Dutch study]. / Behandeling van een aanpassingsstoornis na kanker.

OBJECTIVE: To determine the effectiveness of treatment for an adjustment disorder in accordance with the Dutch guideline for an adjustment disorder in cancer survivor (i.e. people living with or after cancer) on distress, psychological symptoms and quality of life. DESIGN: Prospective cohort in which cancer survivors completed questionnaires prior to and after they received treatment for an adjustment disorder in accordance with the Dutch guideline 'adjustment disorder in patients with cancer'. METHOD: Using paired t-tests, the primary outcomes 'experienced distress' (Distress Thermometer) and 'psychological distress' (HADS) and secondary outcomes functioning, fatigue, and insomnia (EORTC-QLQ-C30) were compared before and after treatment. Clinically relevant improvement was also calculated for each outcome measure. The average costs per treatment were calculated based on the average number of sessions and the indexed NZA rate for the GGZ. RESULTS: A total of 563 cancer survivors received treatment and completed pre- and post-treatment questionnaires. They attended, on average, 11 treatment sessions. The average cost per treatment was €1.141. The results show a statistically significant decrease (p < .001) and a clinically relevant reduction in experienced distress, psychological distress, fatigue, insomnia and a clinically relevant improvement in functioning in cancer survivors following treatment for an adjustment disorder. CONCLUSION: Treatment for adjustment disorder for cancer survivors seems to lead to, at manageable cost, improved quality of life. Inclusion of the guideline in the quality register of the Dutch National Health Care Institute and treatment in accordance with this guideline is recommended.

Measuring Clinical, Biological, and Behavioral Variables to Elucidate Trajectories of Patient-Reported Outcomes: The PROFILES Registry.

To take cancer survivorship research to the next level, it's important to gain insight in trajectories of changing patient-reported outcomes and impaired recovery after cancer. This is needed as the number of survivors is increasing and a large proportion is confronted with changing health after treatment. Mechanistic research can facilitate the development of personalized risk-stratified follow-up care and tailored interventions to promote healthy cancer survivorship. We describe how these trajectories can be studied by taking the recently extended Dutch population-based Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship (PROFILES) registry as an example. PROFILES combines longitudinal assessment of patient-reported outcomes with novel, ambulatory and objective measures (eg, activity trackers, blood draws, hair samples, online food diaries, online cognitive tests, weighing scales, online symptoms assessment), and cancer registry and pharmacy databases. Furthermore, we discuss methods to optimize the use of a multidomain data collection-like return of individual results to participants, which may improve not only patient empowerment but also long-term cohort retention. Also, advanced statistical methods are needed to handle high-dimensional longitudinal data (with missing values) and provide insight into trajectories of changing patient-reported outcomes after cancer. Our coded data can be used by academic researchers around the world. Registries like PROFILES, which go beyond boundaries of disciplines and institutions, will contribute to better predictions of who will experience changes and why. This is needed to prevent and mitigate long-term and late effects of cancer treatment and to identify new interventions to promote health.

Towards OPtimal TIming and Method for promoting sUstained adherence to lifestyle and body weight recommendations in postMenopausal breast cancer survivors (the OPTIMUM-study): protocol for a longitudinal mixed-method study.

BACKGROUND: The majority of postmenopausal breast cancer (PMBC) survivors do not adhere to lifestyle recommendations and have excess body weight. In this group, this is associated with poorer health-related quality of life and an increased risk of type II diabetes mellitus, cardiovascular disease, second primary cancers, cancer recurrences, and mortality. Gaining and maintaining a healthy lifestyle and body composition is therefore important. It is unknown when and how sustained adherence to these recommendations can be promoted optimally in PMBC survivors. Therefore, the OPTIMUM study aims to identify the optimal timing and method for promoting sustained adherence to lifestyle and body weight recommendations in PMBC survivors. METHODS: The OPTIMUM-study has a mixed-methods design. To assess optimal timing, a longitudinal observational study will be conducted among approximately 1000 PMBC survivors. The primary outcomes are adherence to lifestyle and body weight recommendations, readiness for change, and need for support. Questionnaires will be administered at 4-6 months after cancer diagnosis (wave 1: during treatment and retrospectively before diagnosis), 1 year after diagnosis (wave 2: after completion of initial treatment), and 1.5 years after diagnosis (wave 3: during follow-up). Wave 2 and 3 include blood sampling, and either wearing an accelerometer for 7 days or completing a 3-day online food diary (randomly assigned at hospital level). To assess the optimal method, behavioural determinants of the primary outcomes will be matched with Behavior Change Techniques using the Behaviour Change Technique Taxonomy. Qualitative research methods will be used to explore perceptions, needs and preferences of PMBC survivors (semi-structured interviews, focus groups) and health care providers (Delphi study). Topics include perceptions on optimal timing to promote adherence; facilitators and motivators of, and barriers towards (sustained) adherence to recommendations; and acceptability of the selected methods. DISCUSSION: The OPTIMUM study aims to gain scientific knowledge on when and how to promote sustained adherence to lifestyle and body weight recommendations among PBMC survivors. This knowledge can be incorporated into guidelines for tailored promotion in clinical practice to improve health outcomes.

Perceived Care and Well-being of Patients With Cancer and Matched Norm Participants in the COVID-19 Crisis: Results of a Survey of Participants in the Dutch PROFILES Registry.

Importance: As the resolution of the coronavirus disease 2019 (COVID-19) crisis is unforeseeable, and/or a second wave of infections may arrive in the fall of 2020, it is important to evaluate patients' perspectives to learn from this. Objective: To assess how Dutch patients with cancer perceive cancer treatment and follow-up care (including experiences with telephone and video consultations [TC/VC]) and patients' well-being in comparison with a norm population during the COVID-19 crisis. Design, Setting, and Participants: Cross-sectional study of patients participating in the Dutch Patient Reported Outcomes Following Initial Treatment and Long-term Evaluation of Survivorship (PROFILES) registry and a norm population who completed a questionnaire from April to May 2020. Main Outcomes and Measures: Logistic regression analysis assessed factors associated with changes in cancer care (treatment or follow-up appointment postponed/canceled or changed to TC/VC). Differences in quality of life, anxiety/depression, and loneliness between patients and age-matched and sex-matched norm participants were evaluated with regression models. Results: The online questionnaire was completed by 4094 patients (48.6% response), of whom most were male (2493 [60.9%]) and had a mean (SD) age of 63.0 (11.1) years. Of these respondents, 886 (21.7%) patients received treatment; 2725 (55.6%) received follow-up care. Treatment or follow-up appointments were canceled for 390 (10.8%) patients, whereas 160 of 886 (18.1%) in treatment and 234 of 2725 (8.6%) in follow-up had it replaced by a TC/VC. Systemic therapy, active surveillance, or surgery were associated with cancellation of treatment or follow-up appointment. Younger age, female sex, comorbidities, metastasized cancer, being worried about getting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and receiving supportive care were associated with replacement of a consultation with a TC/VC. Patients and norm participants reported that the COVID-19 crisis made them contact their general practitioner (852 of 4068 [20.9%] and 218 of 979 [22.3%]) or medical specialist/nurse (585 of 4068 [14.4%] and 144 of 979 [14.7%]) less quickly when they had physical complaints or concerns. Most patients who had a TC/VC preferred a face-to-face consultation, but 151 of 394 (38.3%) were willing to use a TC/VC again. Patients with cancer were more worried about getting infected with SARS-CoV-2 compared with the 977 norm participants (917 of 4094 [22.4%] vs 175 of 977 [17.9%]). Quality of life, anxiety, and depression were comparable, but norm participants more often reported loneliness (114 of 977 [11.7%] vs 287 of 4094 [7.0%]) than patients with cancer (P = .009). Conclusions and Relevance: Among patients with cancer in the Netherlands, 1 in 3 reported changes in cancer care in the first weeks of the COVID-19 crisis. Long-term outcomes need to be monitored. The crisis may affect the mental well-being of the general population relatively more than that of patients with cancer.

Correction to: Cancer survivors who fully participate in the PROFILES registry have better health-related quality of life than those who drop out.

The original version of the article contains a mistake in figure 2 labeling.

Cancer survivors who fully participate in the PROFILES registry have better health-related quality of life than those who drop out.

PURPOSE: Attrition and subsequent missing data pose a challenge in longitudinal research in oncology. This study examined factors associated with attrition in the PROFILES registry, and its impact on observed health-related quality of life (HRQOL) estimates. METHODS: Sociodemographic, clinical, and HRQOL data were collected annually from a cohort of 2625 colorectal cancer survivors between 2010 and 2015. Participant characteristics according to time of dropout were compared using analysis of variance and chi-square tests. Predictors of attrition were examined in logistic regression analysis. Multilevel linear mixed models were constructed to investigate associations between attrition and HRQOL over time. RESULTS: Participants who dropped out were more likely to be female (OR = 1.23, CI = 1.02-1.47), older (OR = 1.20, CI = 1.09-1.33), less educated (OR = 1.64, CI = 1.30-2.11), and to have depressive symptoms (OR = 1.84, CI = 1.39-2.44) than full responders, and less likely to have high socioeconomic status (OR = 0.74, CI = 0.61-0.94). Participants who dropped out earlier reported significantly worse HRQOL, functioning, and psychosocial symptoms, which declined at a steeper rate over time, than full responders. CONCLUSIONS: Cancer survivors' HRQOL may be overestimated in longitudinal research due to attrition of the most unwell participants. IMPLICATIONS FOR CANCER SURVIVORS: Cancer survivors with the poorest health are at risk of dropping out of PROFILES and possibly withdrawing from other activities. Optimizing participation in PROFILES-a potential mechanism for providing information and access to support-is an avenue for keeping this group engaged.

Financial toxicity is more than costs of care: the relationship between employment and financial toxicity in long-term cancer survivors.

PURPOSE: The aim of this study was to examine the relationship between employment and financial toxicity by examining the prevalence of, and factors associated with, financial toxicity among cancer survivors. METHODS: We conducted a secondary analysis of a sub-sample from the Dutch Patient Reported Outcomes Following Initial Treatment and Long-term Evaluation of Survivorship (PROFILES) registry. Descriptive statistics, bivariate analysis and logistic regression were used. RESULTS: A total of 2931 participants with diverse cancer types were included in the analysis with a mean age of 55 years (range 18 to 65). Nearly half (49%) of participants were employed at the time of the survey, and 22% reported financial toxicity. Those who were not employed were at greater risk of financial toxicity (27% vs 16%, p < 0.001), and this did not vary according to time since diagnosis. The odds of reporting financial toxicity were greater for participants who were male, younger, unmarried, with low education, low socioeconomic status, or without paid employment. Those with basal cell carcinoma had lower risk of financial toxicity, while those with haematological or colorectal cancer had highest risk of financial toxicity. CONCLUSIONS: This research confirms that unemployment is significantly associated with financial toxicity and that those with limited financial resources are most at risk. IMPLICATIONS FOR CANCER SURVIVORS: Increased awareness of financial toxicity and its associated factors among clinicians may result in improved screening and appropriate referrals for support services. The implementation of effective multidisciplinary return to work interventions, as part of standard cancer survivorship care, may reduce financial toxicity among cancer survivors.

Cancer survivors not participating in observational patient-reported outcome studies have a lower survival compared to participants: the population-based PROFILES registry.

PURPOSE: The 'Patient Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship' (PROFILES) registry collects patient-reported outcomes (PROs) from short- and long-term cancer survivors in the Netherlands, in a population-based setting. The aim of this analysis is to assess the generalizability of observational PRO research among cancer survivors by comparing socio-demographic and clinical characteristics, and survival of participants and non-participants in cancer survivors invited for questionnaire research through the PROFILES registry. METHODS: Between 2008 and 2015, cancer survivors with different cancer diagnoses (N = 14,011) were invited to participate in PROFILES registry studies, of whom 69% (N = 9684) participated. Socio-demographic and clinical characteristics and survival data, collected through the Netherlands Cancer Registry, were associated with participation versus non-participation in multivariable logistic regression analyses and cox proportional hazard regression models, respectively. RESULTS: Participants had a significantly better survival compared to non-participants (HR = 1.47, P < .01). Participation was associated with male gender, being 60-70 years old, high socio-economic status, receiving any treatment, receiving radiotherapy, having no comorbidities, and a cancer diagnosis 2-3 years before invitation. Sensitivity analysis demonstrates that the health-related quality of life (HRQoL) might be up to 1.3 points lower (scale 0-100) using hot deck imputation compared to non-imputed participant data. CONCLUSIONS: Cancer survivors not participating in observational PROs research significantly differ from participants, with respect to socio-demographic and clinical characteristics, and survival. Their HRQoL scores may be systematically lower compared to participants. Therefore, even in PRO studies with relatively high participation rates, observed outcomes may represent the healthier patient with better outcomes.

Reference data of the EORTC QLQ-C30 questionnaire: five consecutive annual assessments of approximately 2000 representative Dutch men and women.

OBJECTIVE: Cancer and its treatment have an influence on health-related quality of life (HRQOL). Normative data could help to interpret HRQOL among cancer patients. Our aim was to generate longitudinal normative data based on sex, age and morbidity for the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. METHODS: The QLQ-C30 and the Self-administered Comorbidity Questionnaire were administered to a representative panel of the Dutch-speaking population in the Netherlands in 2009 (n = 1743), 2010 (n = 2050), 2011 (n = 2040), 2012 (n = 2194) and 2013 (n = 2333). RESULTS: Regarding sex, at baseline, women scored statistically significant and clinically relevant worse on fatigue, pain and insomnia compared to men. Regarding age groups and sex, HRQoL was lower among the older age groups in men and women. For men, at baseline, significant and clinically relevant age differences were found on physical, role and cognitive functioning, global QOL scale, fatigue, pain and dyspnea. The change over 5 years was larger for older age groups. For women, at baseline, significant and clinically relevant age differences were found on physical functioning, role functioning, nausea/vomiting, pain, dyspnea and insomnia. Those without self-reported morbidities reported a better HRQoL compared to those with morbidities. Among those who completed five assessments, the summary scale scores were stable over time, were higher in men than in women, and higher in younger compared to older age groups. CONCLUSIONS: Although HRQoL remains relatively stable over time, HRQoL data needs to be interpreted with care as many confounding factors can have an impact on HRQOL. Our data (which is freely available) can aid in the interpretation of QLQ-C30 scores and can help increase our understanding of the influence of age, sex, time and morbid conditions on HRQoL among cancer patients.

"Am I normal?" The Wishes of Patients With Lymphoma to Compare Their Patient-Reported Outcomes With Those of Their Peers.

BACKGROUND: Providing feedback to patients on their patient-reported outcomes (PROs) can help patients in monitoring their functioning and symptoms and may help empower them. OBJECTIVE: The objective of this study was to investigate whether patients with lymphoma wished to receive PRO feedback, including the option to compare their scores with those of their peers, and how this feedback was evaluated. METHODS: We invited 64 patients participating in a lymphoma cohort who were eligible for a follow-up questionnaire and gave them the option to receive PRO feedback. Patients completed questions about health-related quality of life (HRQoL) and symptoms. PRO feedback was provided via bar charts. RESULTS: Of the 64 invited patients, 45 participated (response rate 70%) and 36 of those (80%) wished to receive PRO feedback. The vast majority (34/36, 94%) compared their scores with those of a lymphoma reference cohort, and 64% (23/36) compared their score with those of a normative population without cancer. All patients wished to receive feedback on their HRQoL, and 29 (81%) to 33 (92%) wanted feedback on their functioning, fatigue, neuropathy, anxiety, and depressive symptoms. Of the 36 participants wishing to receive PRO feedback, 35 (97%) viewed it as being useful, with reassurance and knowledge about their own functioning in relation to what is "normal" being the most frequently mentioned reasons. CONCLUSIONS: A high number of patients with lymphoma wished to receive PRO feedback. Patients reported the comparison of their scores versus a lymphoma reference cohort as most valuable. Further research should investigate whether PRO feedback could increase empowerment and possibly improve HRQoL.

Response rates for patient-reported outcomes using web-based versus paper questionnaires: comparison of two invitational methods in older colorectal cancer patients.

BACKGROUND: Improving questionnaire response rates is an everlasting issue for research. Today, the Internet can easily be used to collect data quickly. However, collecting data on the Internet can lead to biased samples because not everyone is able to access or use the Internet. The older population, for example, is much less likely to use the Internet. The Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship (PROFILES) registry offers a platform to collect Web-based and paper questionnaires and to try different measures to improve response rates. OBJECTIVE: In this study, our aim was to study the influence of two methods of invitation on the response rate. Our second aim was to examine the preference of questionnaire mode of administration (paper or Web-based) for the older patient in particular. METHODS: To test these two invitational methods, 3406 colorectal cancer patients between ages 18 and 85 years received an invitation containing an access code for the Web-based questionnaire. They could also request a paper questionnaire with an included reply card (paper-optional group). In contrast, 179 randomly selected colorectal cancer patients received a paper questionnaire with the invitation (paper-included group). They could also choose to fill out the Web-based questionnaire with the included access code. RESULTS: Response rates did not differ between the paper-optional and the paper-included groups (73.14%, 2491/3406 and 74.9%, 134/179, P=.57). In the paper-optional group, online response was significantly higher when compared to the paper-included group (41.23%, 1027/2491 vs 12.7%, 17/134, P<.001). The majority of online respondents responded after the first invitation (95.33%, 979/1027), which was significantly higher than the paper respondents (52.19%, 764/1464, P<.001). Respondents aged 70 years and older chose to fill out a paper questionnaire more often (71.0%, 677/954). In the oldest age group (≥80 years), 18.2% (61/336) of the respondents filled out a Web-based questionnaire. CONCLUSIONS: The lack of difference in response rates between invitation modes implies that researchers can leave out a paper questionnaire at invitation without lowering response rates. It may be preferable not to include a paper questionnaire because more respondents then will fill out a Web-based questionnaire, which will lead to faster available data. However, due to respondent preference, it is not likely that paper questionnaires can be left out completely in the near future.

The Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship registry: scope, rationale and design of an infrastructure for the study of physical and psychosocial outcomes in cancer survivorship cohorts.

'Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship (PROFILES)' is a registry for the study of the physical and psychosocial impact of cancer and its treatment from a dynamic, growing population-based cohort of both short and long-term cancer survivors. PROFILES contains a large web-based component and are linked directly to clinical data from the population-based Eindhoven cancer registry. This paper describes the rationale and design of PROFILES. The primary aims of studies that use the PROFILES registry are: (1) psychosocial risk and outcome assessment to identify patients at high risk for poor physical and mental health outcomes, (2) to analyse mediating mechanisms to better understand the biological and behavioural factors associated with cancer treatment outcomes, and (3) to evaluate physical and psychosocial care needs of cancer survivors. PROFILES is a tool that enables data collection management; from inviting patients to participation in studies, to collecting patient-reported outcomes data via web-based or mailed questionnaires and linking these data with clinical data. The availability of a control cohort of approximately 2000 persons from the general population who complete the same basic questionnaire annually will provide the opportunity to estimate the unique impact of cancer, beyond that of normal ageing and comorbidities. Raw data from the PROFILES registry will be available for non-commercial scientific research, subject to study question, privacy and confidentiality restrictions, and registration (www.profilesregistry.nl).