Abstract
BackgroundOver the past years knowledge about benefits of physical activity after cancer is evolving from randomized exercise intervention trials. However, it has been argued that results may be biased by selective participation. Therefore, we investigated factors influencing participation in a randomized exercise intervention trial for breast cancer patients.MethodsNon-metastatic breast cancer patients were systematically screened for a randomized exercise intervention trial on cancer-related fatigue. Participants and nonparticipants were compared concerning sociodemographic characteristics (age, marital status, living status, travel time to the training facility), clinical data (body-mass-index, tumor stage, tumor size and lymph node status, comorbidities, chemotherapy), fatigue, and physical activity. Reasons for participation or declination were recorded.Results117 patients (52 participants, 65 nonparticipants) were evaluable for analysis. Multiple regression analyses revealed significantly higher odds to decline participation among patients with longer travel time (p = 0.0012), living alone (p = 0.039), with more comorbidities (0.031), previous chemotherapy (p = 0.0066), of age ≥ 70 years (p = 0.025), or being free of fatigue (p = 0.0007). No associations were found with BMI or physical activity. By far the most frequently reported reason for declination of participation was too long commuting time to the training facility.ConclusionsWillingness of breast cancer patients to participate in a randomized exercise intervention study differed by sociodemographic factors and health status. Neither current physical activity level nor BMI appeared to be selective for participation. Reduction of personal inconveniences and time effort, e.g. by decentralized training facilities or flexible training schedules, seem most promising for enhancing participation in exercise intervention trials.Trial registrationRegistered at ClinicalTrials.gov: NCT01468766 (October 2011).
Highlights
Over the past years knowledge about benefits of physical activity after cancer is evolving from randomized exercise intervention trials
Besides the continuous fatigue scores we investigated a dichotomous variable using as cutpoint the mean fatigue score of women age ≥ 60 years from the general German population (FAQ point value for women aged 14–39 years: 11,2; aged 40–59 years: 12,1; aged ≥ 60 years) [22].To assess the motivation of patients to participate in the BEST-study they could choose among 7 answers, in addition to provide their own free text
The remaining 277 patients were either not eligible, received no information from the recruiting physicians or were not interested in any study participation. Information for this BEST-Participation-study was available for 30.4% of all breast cancer patients with adjuvant radiotherapy during the study period
Summary
Over the past years knowledge about benefits of physical activity after cancer is evolving from randomized exercise intervention trials. We investigated factors influencing participation in a randomized exercise intervention trial for breast cancer patients. Clinical trials are essential for research and randomized controlled studies are considered the gold standard to evaluate new therapies and determine efficacy or effectiveness of interventions [8]. Only 3-5% of all cancer patients in Great Britain and the US are included in randomized controlled studies [9] These low rates result from strict study protocols together with patient- and physician related factors, e.g. time constraints or influence on the relationship between physician and patient. De Jong et al [17] determined differences between participants and nonparticipants of an exercise trial for patients with rheumatoid arthritis. It is important to explore these determinants to improve participation rates in further trials
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