Maike G. Sweegers

PurposeThe European Oncology Quality of Life (EUonQoL) project aims to develop a questionnaire toolkit (EUonQoL-Kit) to assess the quality of life (QoL) of cancer patients and survivors across Europe.MethodsThe EUonQoL-Kit development used mixed-methods and a co-design approach. Data was collected in six countries (Denmark, France, Germany, Italy, Netherlands and UK). The target populations were patients in active treatment (A), survivors (B) and patients requiring palliative care (C). A review of existing QoL theoretical models produced an initial EUonQoL conceptual framework. Semi-structured interviews and a Delphi survey evaluated/modified the framework. Existing validated items were used to construct the toolkit, including Computer Adaptive Testing (CAT), where available. A usability study evaluated EUonQoL-Kit.v1. Data triangulation and consensus methodology guided EUonQoL-Kit.v2.ResultsThe initial conceptual framework covered four multi-dimensional domains: physical, social and overall health, and psychological wellbeing. The interviews and Delphi survey included 75 and 155 participants, respectively. The domain ‘healthcare experience’ was identified and included in the framework. EUonQoL-Kit.v1 resulted in three static questionnaires, one for each target population (n items- A=75; B=67; C=79). Following usability testing with 53 participants, EUonQoL-Kit.v2 was produced via a multi-stakeholder consensus development panel, creating a shortened version (n items- A=50; B=50; C=44). Dynamic versions of these questionnaires were developed using the EORTC CAT Core system.ConclusionsEUonQoL-Kit is a novel toolkit developed to assess QoL across the cancer continuum and inform health policy within Europe. Its psychometric properties are currently being evaluated using data collected on more than 4200 patients across 32 countries.

Purpose: As survival of patients with metastatic breast cancer (MBC) improves, their work situation is gaining importance. The aim of the current study was to identify factors associated with work status and quality of working life (QWL) in patients with MBC. Additionally, we investigated the effects of an exercise intervention on work status. Methods: Within the multinational PREFERABLE‐EFFECT exercise trial, 287 patients with MBC of working age (18–65 years) reported on their working situation over 9 months as a secondary endpoint. Among a subgroup of participants, QWL was assessed by the Quality of Working Life Questionnaire for Cancer Survivors (QWLQ‐CS) ( N = 59). Results: At baseline, 157 (54.7%) participants were employed, of whom one‐third reported having recently reduced their amount of work because of fatigue (41.7%), cognitive problems (33.3%), or inability to meet work demands (33.3%). Participants wished for more flexible working hours (29.2%) and less productivity pressure (37.5%). Participants were less likely to work if they experienced higher levels of pain ( p = 0.014). Among working participants, an academic education and higher levels of psychological distress were associated with a higher number of working hours (all p < 0.05). Fatigue, an academic education, and performing mentally strenuous tasks at work were negatively associated with QWL (all p < 0.05). The exercise intervention did not affect the number of hours worked during the study. Conclusions: Symptom management might be important for patients' ability to work. To help patients stay employed and improve QWL, employers should consider offering more flexible work arrangements and adapting to their employees' changing needs and abilities. Trial Registration: The PREFERABLE‐EFFECT trial was registered with ClinicalTrials.gov on October 9, 2019 (NCT04120298).

The understanding and treatment of sexual health problems, impaired body image, and other non‐life threatening but burdensome symptoms of women with metastatic breast cancer (mBC) is still insufficient. We studied the factors associated with such symptoms and investigated whether these problems could be alleviated by a structured exercise intervention. In the multinational PREFERABLE‐EFFECT study, 355 women with mBC were randomly assigned to usual care (n = 178) or a 9‐month supervised exercise program (n = 177). Breast cancer‐specific functions and symptoms (EORTC QLQ‐BR42) were assessed at baseline, 3, 6 (primary timepoint), and 9 months. Linear regression models and linear mixed models for repeated measures were calculated. At baseline, participants were 55.4 ± 11.2 years old, 52.4% were undergoing endocrine therapy, and 25.4% chemotherapy. Baseline sexual functioning was low, with 94.3% reporting no or little sexual activity. Age and depressive symptoms were negatively associated with sexual functioning. Among sexually active women, 46.2% felt no or little sexual enjoyment and 37.3% suffered from vaginal dryness. Body image was reported as low by 23.7%. Exercise significantly improved sexual functioning (6‐months between‐group difference (BGD) = 5.6, 95% CI [1.9, 9.4], effect size (ES) = 0.28) and vaginal symptoms (BGD = −7.1 [−11.7, −2.5], ES = 0.25), compared to usual care. Effects on body image were marginal (BGD = 4.0 [−0.2, 8.3], ES = 0.14). Among participants undergoing chemotherapy (n = 90), exercise reduced chemotherapy side‐effects (BGD = −8.2 [−15.4, −1.0], ES = 0.48). In conclusion, women with mBC often experience sexual and vaginal problems and other treatment‐related side‐effects. A 9‐month supervised exercise program vs. control was effective in improving sexual functioning and vaginal symptoms among women with mBC.

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.

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.

Background: Whole blood donors are at increased risk for iron deficiency and anaemia. The current standard of haemoglobin (Hb) monitoring is insufficient to ensure the maintenance of proper iron reserves and donor health. We determine the effects of ferritin-guided donation intervals for blood donors and the blood supply. Methods: A ferritin-guided donation interval policy was implemented and evaluated through a stepped-wedge cluster-randomised controlled trial in all blood collection centres in the Netherlands. Ferritin was measured in new donors and at every 5th donation. Subsequent donation intervals were extended to six months if ferritin was 15 - 30 ng/mL and to twelve months if ferritin was th , 2017 ( https://trialsearch.who.int/Trial2.aspx?TrialID=NTR6738 ).

Background: Whole blood donors may experience post‐donation symptoms such as fatigue, dizziness, or headache after blood donation, which could influence donor retention. We aimed to examine post‐donation symptoms during 1 week after whole blood donation, investigate donor characteristics associated with symptoms, and evaluate associations between symptoms and donor return.Methods: During 1 week, whole blood donors who donated successfully at one of the collection centers in The Netherlands were invited to participate. Three thousand seventy six donors filled in a diary, assessing post‐donation symptoms during days 1 to 6 after donation. We used linear mixed models analyses to determine the change in post‐donation symptoms after donation for male and female donors separately. Furthermore, we investigated associations between post‐donation symptoms and donors' physical characteristics using multivariable regression and determined associations between symptoms and donor return.Results: Donors reported fatigue as the most common symptom, with approximately 3% of donors experiencing severe problems at the first day after donation. Multiple symptoms improved significantly up to day 3 after whole blood donation. Age, BMI, blood pressure (male donors), and blood volume (female donors) were significantly associated with post‐donation symptoms. Donors with less fatigue after whole blood donation were more likely to return for their next donation within 31 days after receiving an invitation.Conclusion: Post‐symptoms improve up to 3 days after whole blood donation. Our results may help blood collection centers to identify donors more prone to post‐donation symptoms and provide personalized information about the presence and course of post‐donation symptoms, possibly increasing donor return rates.

Background: Blood donors are at risk for reduced iron stores, because of which donor iron monitoring received increased attention in the last decade. Despite the importance for donor health, international consensus on an appropriate policy for iron monitoring is lacking. Therefore, we conduct a trial to evaluate to what extent ferritin-guided donation intervals are effective in increasing haemoglobin and ferritin levels, decreasing low-haemoglobin deferral, increasing donor return and improving the health of whole blood donors in the Netherlands. Methods: Sanquin Blood Bank is implementing ferritin-guided donation intervals to prevent donors from increasing iron loss at repeated donations. Using a stepped wedge cluster randomised trial approach, the design involves a random crossover of 29 clusters of blood collection centres from the existing policy without ferritin measurements to a ferritin-guided donation interval policy. This new policy includes ferritin measurements for all new donors and at every 5th whole blood donation, extending donation intervals to 6 months if ferritin is 15–≤ 30 ng/mL and to 12 months if ferritin is < 15 ng/mL. We measure ferritin levels of whole blood donors from stored plasma samples and collect haemoglobin levels and information on low-haemoglobin deferral and donor return from the donor database before, during and after the implementation period. We measure donor health during and after the implementation period using questionnaires, assessing physical and mental wellbeing and iron deficiency- and donation-related symptoms. We use multilevel analyses to investigate differences in ferritin and haemoglobin levels, low-haemoglobin deferral rates, donor return and donor health from whole blood donors, between blood collection centres that have versus those that have not yet implemented the ferritin-guided donation interval policy. Discussion: This stepped wedge cluster randomised trial will provide insight into the effectiveness of ferritin-guided donation intervals in lowering iron deficiency, decreasing donor deferrals due to low haemoglobin and improving donor health. We will evaluate a policy that is implemented nationwide in a real-life setting. Our study is therefore not limited to a small experimental setting and the results will guide policymakers seeking an appropriate policy for iron monitoring. Trial registration: The Dutch trial registry NTR6738. Registered on 29 September 2017. Retrospectively registered.