An Exercise Trial and Economic Analysis in Men With Prostate Cancer
ADT Ex RCT
A Pilot RCT and Economic Analysis of Three Exercise Delivery Methods in Men With Prostate Cancer on ADT
1 other identifier
interventional
59
1 country
2
Brief 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; (b) home-based supported; and (c) 1:1 supervised in-centre 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. The investigators will ask men with PC on ADT that are being treated at either Princess Margaret Cancer Centre in Toronto or the Tom Baker Cancer Centre in Calgary to participate in the study. When a patient agrees to participate, he will be randomly placed in 1 of the 3 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 prostate-cancer
Started Nov 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 20, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedApril 13, 2021
April 1, 2021
4.2 years
January 20, 2014
April 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in health-related quality of life (QOL) at 3, 6, 9, and 12 months
Measured by the Functional Assessment of Cancer Therapy-General (FACT-G), health-related QOL refers to those aspects of QOL that relate a person's health to their physical, functional, psychological, and social well-being. The FACT-G is a well-validated and widely used QOL measure. It can be completed in 8-10 minutes and has published normative data.
Every 3 months for 1 year
Secondary Outcomes (10)
Change from baseline in quality of life (QOL) at 3, 6, 9, and 12 months
Every 3 months for 1 year
Change from baseline in fatigue at 3, 6, 9, and 12 months
Every 3 months for 1 year
Change from baseline in aerobic fitness (VO2peak) at 3, 6, 9, and 12 months
Every 3 months for 1 year
Change from baseline in musculoskeletal fitness at 3, 6, 9, and 12 months
Every 3 months for 1 year
Change from baseline in grip strength at 3, 6, 9, and 12 months
Every 3 months for 1 year
- +5 more secondary outcomes
Study Arms (3)
Supervised 1:1 exercise
EXPERIMENTALThis intervention arm will include 3 one-on-one, supervised sessions per week for 6 months with a certified exercise specialist. Flexibility training will include stretching for 5-10 minutes at the beginning and end of each session. Aerobic training will involve 30 minutes of low-impact step aerobics. Resistance training will be conducted using resistance bands, a stability ball, and an exercise mat with 8 prescribed exercises that target the major muscle groups. Participants will be encouraged to perform exercises independently on additional days, for a total of 4-5 days per week of exercise.
Supervised group exercise
EXPERIMENTALThis intervention arm will include 3 group, supervised sessions per week for 6 months with a certified exercise specialist. Supervised sessions will be delivered in a group format with 4-8 participants per group. Flexibility training will include stretching for 5-10 minutes at the beginning and end of each session. Aerobic training will involve 30 minutes of low-impact step aerobics. Resistance training will be conducted using resistance bands, a stability ball, and an exercise mat with 8 prescribed exercises that target the major muscle groups. Participants will be encouraged to perform exercises independently on additional days, for a total of 4-5 days per week of exercise.
Home-based exercise
EXPERIMENTALThe same protocol and training frequency as the supervised programs described above will be followed. However, all exercises will be completed independently by participants. Specific exercises in the aerobic program may be modified to accommodate patient preference (same target heart rate range as supervised groups). Participants will be supported with smartphone technology and remote 'health coaches' during the intervention phase. This will help to ensure participant adherence, appropriate progression, and safety.
Interventions
The exercise program will be delivered in a personal training (1:1) format by a certified exercise specialist.
The exercise program will be delivered in a group format (4-8 participants per group) by a certified exercise specialist.
The exercise program will be executed independently by participants in a home-based setting. Home-based participants will be supported with remote health coaching and smartphone technology.
Eligibility Criteria
You may qualify if:
- confirmed prostate cancer
- starting or continuing on ADT for at least 6 months
- fluent in English
- able to provide consent
- live close to a study centre
- screened with the Physical Activity Readiness Questionnaire (PAR-Q+ or PARmed-X) to ensure safe exercise participation OR receive medical clearance by attending physician
You may not qualify if:
- already meeting guidelines for moderate to vigorous physical activity (MVPA) as defined by the Canadian Physical Activity Guidelines (greater than or equal to 150 minutes of MVPA per week)
- conditions that would interfere with ability to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Calgary/Tom Baker Cancer Centre
Calgary, Alberta, T2N 1N4, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5T 2M9, Canada
Related Publications (3)
Papadopoulos E, Leach HJ, Tomlinson G, Durbano S, Danyluk JM, Sabiston CM, Mina DS, Alibhai SMH, Culos-Reed SN. Factors predicting gains in moderate-to-vigorous physical activity in prostate cancer survivors on androgen deprivation therapy. Support Care Cancer. 2022 Nov;30(11):9011-9018. doi: 10.1007/s00520-022-07300-2. Epub 2022 Aug 10.
PMID: 35948848DERIVEDAlibhai SMH, Santa Mina D, Ritvo P, Tomlinson G, Sabiston C, Krahn M, Durbano S, Matthew A, Warde P, O'Neill M, Timilshina N, Segal R, Culos-Reed N. A phase II randomized controlled trial of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy. BMC Cancer. 2019 Jan 3;19(1):2. doi: 10.1186/s12885-018-5189-5.
PMID: 30606137DERIVEDAlibhai SM, Santa Mina D, Ritvo P, Sabiston C, Krahn M, Tomlinson G, Matthew A, Segal R, Warde P, Durbano S, O'Neill M, Culos-Reed N. A phase II RCT and economic analysis of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy. BMC Cancer. 2015 Apr 25;15:312. doi: 10.1186/s12885-015-1316-8.
PMID: 25908311DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shabbir MH Alibhai, MD, MSc
University Health Network, Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2014
First Posted
January 28, 2014
Study Start
November 1, 2013
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
April 13, 2021
Record last verified: 2021-04