Distance-based delivery of exercise for people treated for breast, prostate or colorectal cancer: a study protocol for a randomised controlled trial of EX-MED Cancer Sweden

Trials

Study Protocol

Melissa Kotte¹  Kate A. Bolam²  Sara Mijwel³  Yvonne Wengström⁴  Renske Altena⁵  Prue Cormie⁶ 

[1] Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden;Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden;Department of Physical Activity and Health, The Swedish School of Sport and Health Sciences, Stockholm, Sweden;Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden;Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway;Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden;Medical Unit Breast, Endocrine Tumors and Sarcoma, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden;Medical Unit Breast, Endocrine Tumors and Sarcoma, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden;Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden;Peter MacCallum Cancer Centre, Melbourne, VIC, Australia;Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia;EX-MED Cancer, Melbourne, VIC, Australia;

关键词: Exercise;    Cancer;    Fitness;    Distance-based;    Home-based;   

DOI  :  10.1186/s13063-023-07152-z

 received in 2022-12-13, accepted in 2023-02-10,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundRegular exercise has been shown to have beneficial health effects in cancer survivors, including improving quality of life and other important health outcomes. However, providing people with cancer with easily accessible, high-quality exercise support and programs is a challenge. Therefore, there is a need to develop easily accessible exercise programs that draw upon the current evidence. Supervised, distance-based exercise programs have the benefit of reaching out to many people whilst providing the support of an exercise professional. The aim of the EX-MED Cancer Sweden trial is to examine the effectiveness of a supervised, distance-based exercise program, in people previously treated for breast, prostate, or colorectal cancer, on health-related quality of life (HRQoL), as well as other physiological and patient-reported health outcomes.MethodsThe EX-MED Cancer Sweden trial is a prospective randomised controlled trial including 200 people that have completed curative treatment for breast, prostate, or colorectal cancer. Participants are randomly allocated to an exercise group or a routine care control group. The exercise group will participate in a supervised, distanced-based exercise program delivered by a personal trainer who has undertaken specialised exercise oncology education modules. The intervention consists of a combination of resistance and aerobic exercises with participants completing two 60-min sessions per week for 12 weeks. The primary outcome is HRQoL (EORTC QLQ-C30) assessed at baseline, 3- (end of intervention and primary endpoint) and 6-months post-baseline. Secondary outcomes are physiological (cardiorespiratory fitness, muscle strength, physical function, body composition) and patient-reported outcomes (cancer-related symptoms, fatigue, self-reported physical activity), and self-efficacy of exercise. Furthermore, the trial will explore and describe the experiences of participation in the exercise intervention.DiscussionThe EX-MED Cancer Sweden trial will provide evidence regarding the effectiveness of a supervised, distance-based exercise program for survivors of breast, prostate, and colorectal cancer. If successful, it will contribute to the implementation of flexible and effective exercise programs as part of the standard of care for people following cancer treatment, which is likely to contribute to a reduction in the burden of cancer on the individual, health care system and society.Trial registrationwww.ClinicalTrials.gov NCT05064670. Registered on October 1, 2021.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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