A phase II RCT and economic analysis of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy

BMC Cancer

Shabbir MH Alibhai¹  Daniel Santa Mina⁶  Paul Ritvo⁴  Catherine Sabiston⁵  Murray Krahn⁵  George Tomlinson⁵  Andrew Matthew⁵  Roanne Segal²  Padraig Warde⁵  Sara Durbano⁷  Meagan O’Neill⁵  Nicole Culos-Reed³ 

[1] Toronto General Hospital, 200 Elizabeth St Room EN14-214, Toronto M5G 2C4, ON, Canada

[2] University of Ottawa, Ottawa K1N 6N5, ON, Canada

[3] Tom Baker Cancer Centre, Calgary T2N 4N2, AB, Canada

[4] York University, Toronto M3J 1P3, ON, Canada

[5] University of Toronto, Toronto M5S 2J7, ON, Canada

[6] University of Guelph Humber, Toronto M9W 5L7, ON, Canada

[7] University Health Network, Toronto M5G 2C4, ON, Canada

关键词: Patient adherence;    Cost-effectiveness;    Physical fitness;    Fatigue;    Quality of life;    Randomized controlled trial;    Exercise;    Androgen deprivation therapy;    Prostate cancer;   

Others  :  1177500
DOI  :  10.1186/s12885-015-1316-8

 received in 2014-10-24, accepted in 2015-04-13,  发布年份 2015

【 摘 要 】

Background

Androgen deprivation therapy is commonly used to treat prostate cancer, the most common visceral cancer in men. However, various side effects often worsen physical functioning and reduce well-being among men on this treatment. Based on existing evidence, both resistance and aerobic training provide benefits for this population yet adherence rates are often low. The method of exercise delivery (supervised in-center or home-based) may be important, yet few studies have compared different models. Additionally, long-term exercise adherence is critical to achieve sustained benefits but long-term adherence data and predictors of adherence are lacking. The primary aim of this phase II, non-inferiority randomized controlled trial is to determine whether three exercise training delivery models are equivalent in terms of benefits in quality of life and physical fitness in this population. Secondary aims include examination of long-term adherence and cost-effectiveness.

Design

Men diagnosed with prostate cancer, starting or continuing on androgen deprivation therapy for at least 6 months, fluent in English, and living close to one of two experienced Canadian study centers are eligible. Participants complete five assessments over one year, including a fitness assessment and self-report questionnaires. Socio-demographic and clinical data collection occur at baseline, bone mineral density testing at two time points, and blood work is performed at three time points. Participants are randomized in a 1:1:1 fashion to supervised personal training, supervised group training, or home-based smartphone- and health coach-supported training. Each participant receives a detailed exercise manual, including illustrations of exercises and safety precautions. Participants are asked to complete 4 to 5 exercise sessions per week, incorporating aerobic, resistance and flexibility training. Participant intensity levels will be monitored. The intervention duration is 6 months, with 6 months additional follow-up. Outcomes include: body composition, fitness testing, quality of life and fatigue, biological outcomes, and program adherence. Cost information will be obtained using patient diary-based self-report.

Discussion

The goals of this study are to gain a better understanding of health benefits and costs associated with commonly used yet currently not compared exercise delivery models as well as an increased understanding of adherence to exercise.

Trial registration

The trial has been registered at clinicaltrials.gov (Registration # NCT02046837), registered January 20^th, 2014.

【 授权许可】

   
2015 Alibhai et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

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