ADT Exercise Trial and Economic Analysis

Official Title

A Randomized Control Trial (RCT) and Economic Analysis of Two Exercise Delivery Methods in Men With Prostate Cancer on ADT

Summary:

Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC but has many side effects. Researchers have shown that exercise, specifically one-on-one supervised exercise improves many of the side effects of ADT. However, exercise programs for men on ADT are not widely available. More questions need to be answered in order for exercise programs to become part of PC treatment. First, can programs that require fewer resources, such as group-exercise or home-based exercise, also improve ADT side-effects? Second, do exercise-related benefits continue beyond the structured exercise program? And what makes people continue exercising? Third, which exercise program is most cost-effective?

In this study, the investigators will compare: (a) group supervised in-centre and (b) home-based supported exercise programs to see which program is most effective for men with PC on ADT. The investigators will also look at what motivates people to continue to exercise both during a structured program and after the program is complete and will examine which exercise program is most cost-effective.

Participants (men with PC on ADT) will be recruited from one of the following cancer centres: Princess Margaret Cancer Centre in Toronto, the Tom Baker Cancer Centre in Calgary, the Juravinski Cancer Centre in Hamilton, and the Southlake Regional Health Centre in Newmarket. When a patient agrees to participate, patient will be randomly placed in 1 of 2 exercise programs. All programs will include the same type of exercises (aerobic, resistance and flexibility) and all participants will exercise 4-5 days per week for 30 minutes per day (as tolerated) for the length of the program (6 months). The investigators will look at how men with PC on ADT respond to the exercise program by measuring quality of life (QOL), fatigue and different physical measures before, during, and after the exercise program.

Although the investigators know that supervised one-on-one exercise is most effective at improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial and more financially responsible. This study will allow the investigators to begin to answer these questions so that structured exercise programs become a regular part of PC treatment.

Trial Description

Primary Outcome:

  • Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
  • 6 Minute Walk Test (6MWT)
Secondary Outcome:
  • Functional Assessment of Cancer Therapy-General (FACT-G)
  • Functional Assessment of Cancer Therapy-Prostate (FACT-P)
  • 5 Times Sit to Stand Test
  • Grip Strength
  • Bioelectrical Impedance Analysis
  • Waist Circumference and Hip Ratio
  • Body Mass Index
  • Bone Mineral Density (BMD)
  • Biological Outcomes (blood work)
  • Sedentary Behaviour
  • Planning, Attitudes, & Barriers scale
  • Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2)
  • Psychological Need Support and Frustration Scale - Relatedness Items
  • Health Care Climate Questionnaire (HCCQ)
  • Walkability
  • Disease-related Costs
  • Exercise Adherence

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society