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

Joanne Land; Orla McCourt; Malgorzata Heinrich; Rebecca J Beeken; Dimitrios A Koutoukidis; Bruce Paton; Kwee Yong; Allan Hackshaw; Abigail Fisher

doi:10.1016/j.jclinepi.2020.04.004

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

J Clin Epidemiol. 2020 Sep:125:76-83. doi: 10.1016/j.jclinepi.2020.04.004. Epub 2020 Apr 11.

Authors

Joanne Land¹, Orla McCourt², Malgorzata Heinrich¹, Rebecca J Beeken³, Dimitrios A Koutoukidis⁴, Bruce Paton⁵, Kwee Yong⁶, Allan Hackshaw⁷, Abigail Fisher⁸

Affiliations

¹ Department of Behavioural Science and Health, University College London, WC1E 7HB, London, UK.
² Department of Behavioural Science and Health, University College London, WC1E 7HB, London, UK; Research Department of Haematology, Cancer Institute, University College London, London, UK; University College London Hospitals NHS Foundation Trust, London, UK.
³ Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
⁴ Department of Behavioural Science and Health, University College London, WC1E 7HB, London, UK; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; NIHR Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
⁵ Institute of Sport Exercise & Health, London, UK.
⁶ Research Department of Haematology, Cancer Institute, University College London, London, UK.
⁷ Cancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.
⁸ Department of Behavioural Science and Health, University College London, WC1E 7HB, London, UK. Electronic address: abigail.fisher@ucl.ac.uk.

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.

Keywords: Exercise; Exercise-oncology; Multiple myeloma; Physical activity; Post randomization consent; Research design.

Publication types

Clinical Trial
Observational Study
Research Support, Non-U.S. Gov't

MeSH terms

Cancer Survivors / psychology*
Cohort Studies
Exercise Therapy / methods*
Feasibility Studies
Female
Humans
Informed Consent
Male
Multiple Myeloma / psychology
Multiple Myeloma / rehabilitation*
Patient Satisfaction
Patient Selection
Quality of Life / psychology*
Random Allocation
Research Design

Abstract

Publication types

MeSH terms

Grants and funding