Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 8, 2020
Date Accepted: May 18, 2021
Date Submitted to PubMed: Aug 12, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Implementing exercise in standard cancer care: Bizi Orain hybrid, clinical and implementation randomized trial study protocol to evaluate the effectiveness of a community-based exercise programme for people living with cancer
ABSTRACT
Background:
Despite the established benefits of regular exercise for cancer patients to counteract the deleterious effects of the disease itself, and treatment-related side-effects, most of them do not engage in sufficient levels of physical activity and there is a paucity of data on the integration of efficacious exercise programmes that are accessible and generalizable to a large proportion of cancer patients into routine cancer care. This paper describes the implementation of Bizi Orain, a community-based exercise programme for people with cancer, and the protocol for the programme evaluation.
Objective:
To describe the implementation of a community-based exercise programme for cancer patients (“Bizi Orain”) and the protocol for programme evaluation.
Methods:
This will be a hybrid study, with a first experimental phase in which patients diagnosed with any type of cancer will be randomized to two parallel groups, one that immediately performs Bizi Orain, a 3-month supervised exercise programme (3 times a week) in addition to behavioural counselling in a primary healthcare setting, and the other, a reference group that starts the exercise programme 3 months later (delayed treatment). In a second observational phase, the entire cohort of participants will be followed-up for 5 years. Any person diagnosed with cancer in the previous 2 years is eligible for the programme. Evaluation of the programme involves uptake, safety, adherence and effectiveness assessed on the completion of the programme and at 3, 6, 12, 24, 36, 48 and 60 months of follow-ups. The primary outcomes of the experimental study, to be compared between groups, are physical function and patient-reported outcomes, whereas overall survival is the main endpoint of the prospective study. To analyse the association between changes in physical activity level and overall survival, longitudinal mixed-effects models will be used for repeated follow-up measures.
Results:
It is a protocol, so there are no results
Conclusions:
Bizi Orain is the first population-based exercise programme in Spain that will offer more insight into the implementation of feasible, generalizable and sustainable supportive care services involving structured exercise to extend cancer patients’ survival, improve their physical function and quality of life, and reverse the side-effects of their disease and related treatments, thereby reducing the clinical burden. Clinical Trial: Clinical Trials.gov Identifier: NCT03819595. Date of registration: 18/01/2019
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.