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The adapted Zelen was a feasible design to trial exercise in myeloma survivors.

ABSTRACT: OBJECTIVES:We used a method rarely seen in cancer behavioral trials to explore methods of overcoming difficulties often seen in randomized controlled trials. We report our experiences of the adapted Zelen design, so that other researchers can consider this approach for behavioral trials. STUDY DESIGN AND SETTING:The adapted Zelen design was used to explore the effects of exercise on multiple myeloma patients fatigue, quality of life, and physical outcomes. All participants consented to an observational cohort study of lifestyle factors but were unaware of subsequent randomization to remain in cohort only group or be offered an exercise intervention requiring second consent. RESULTS:There was lower than expected uptake to the exercise offered group (57%), so the length of recruitment increased from 24 to 29 months to ensure power was reached. At enrollment, patients were unaware of the potential increased commitment, and as a result, 62% of participants allocated to the intervention declined because of the extra time/travel commitment required. This emulates clinical settings and suggests improvements in intervention delivery are required. Our findings suggest that the adapted Zelen design may be useful in limiting dropout of controls due to dissatisfaction from group allocation, or contamination of control arm. CONCLUSION:Future use of this design warrants careful consideration of the study resources and recruitment time frames required but holds potential value in reducing contamination, control group dissatisfaction, and resulting dropout. Adapted Zelen design reduces selection bias and therefore gives clinicians a better understanding of acceptability in clinical settings. Future studies should evaluate control group experiences of the design and formally record contamination throughout the study to confirm its acceptability.

SUBMITTER: Land J

PROVIDER: S-EPMC7482584 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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The adapted Zelen was a feasible design to trial exercise in myeloma survivors.

Land Joanne J McCourt Orla O Heinrich Malgorzata M Beeken Rebecca J RJ Koutoukidis Dimitrios A DA Paton Bruce B Yong Kwee K Hackshaw Allan A Fisher Abigail A

Journal of clinical epidemiology 20200411

<h4>Objectives</h4>We used a method rarely seen in cancer behavioral trials to explore methods of overcoming difficulties often seen in randomized controlled trials. We report our experiences of the adapted Zelen design, so that other researchers can consider this approach for behavioral trials.<h4>Study design and setting</h4>The adapted Zelen design was used to explore the effects of exercise on multiple myeloma patients fatigue, quality of life, and physical outcomes. All participants consent ...[more]

PMID: 32289352

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Project description:BackgroundMetabolic syndrome (MetS) is increasingly present in breast cancer survivors, possibly worsened by cancer-related treatments, such as chemotherapy. MetS greatly increases risk of cardiovascular disease and diabetes, co-morbidities that could impair the survivorship experience, and possibly lead to cancer recurrence. Exercise has been shown to positively influence quality of life (QOL), physical function, muscular strength and endurance, reduce fatigue, and improve emotional well-being; however, the impact on MetS components (visceral adiposity, hyperglycemia, low serum high-density lipoprotein cholesterol, hypertriglyceridemia, and hypertension) remains largely unknown. In this trial, we aim to assess the effects of combined (aerobic and resistance) exercise on components of MetS, as well as on physical fitness and QOL, in breast cancer survivors soon after completing cancer-related treatments.Methods/designThis study is a prospective randomized controlled trial (RCT) investigating the effects of a 16-week supervised progressive aerobic and resistance exercise training intervention on MetS in 100 breast cancer survivors. Main inclusion criteria are histologically-confirmed breast cancer stage I-III, completion of chemotherapy and/or radiation within 6 months prior to initiation of the study, sedentary, and free from musculoskeletal disorders. The primary endpoint is MetS; secondary endpoints include: muscle strength, shoulder function, cardiorespiratory fitness, body composition, bone mineral density, and QOL. Participants randomized to the Exercise group participate in 3 supervised weekly exercise sessions for 16 weeks. Participants randomized to the Control group are offered the same intervention after the 16-week period of observation.DiscussionThis is the one of few RCTs examining the effects of exercise on MetS in breast cancer survivors. Results will contribute a better understanding of metabolic disease-related effects of resistance and aerobic exercise training and inform intervention programs that will optimally improve physiological and psychosocial health during cancer survivorship, and that are ultimately aimed at improving prognosis.Trial registrationNCT01140282;RegistrationJune 10, 2010.

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The adapted Zelen was a feasible design to trial exercise in myeloma survivors.

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The adapted Zelen was a feasible design to trial exercise in myeloma survivors.

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