Preference-Based Exercise RCT for Men With PC on ADT
PBExRCT
A Preference-Based Trial of Two Exercise Delivery Methods in Men With PC on ADT
1 other identifier
interventional
56
1 country
3
Brief Summary
Prostate cancer affects 1 in 7 men. Half of these men are treated with androgen deprivation therapy (ADT). ADT slows disease progression and prolongs survival, but it also leads to worse quality of life (QOL), fatigue, loss of strength and fitness, osteoporosis, and diabetes. The investigators' recent research has shown that individually supervised exercise, supervised group exercise and home-based exercise are equally good at improving these side effects. Now the investigators are doing a larger trial with multiple centres to see whether supervised group or home-based exercise is clinically better and more economical. A major challenge in such trials is that a significant number of men refuse to be randomized because (a) the participant lives too far from a study centre and cannot come for supervised exercise; or (b) the participant has a strong preference as to which type of exercise program the participant wants to do. Experts have raised concerns that classic randomized trials are too restrictive, selective, and less practical; the study results are less applicable to the real world. Despite its obvious importance, it is not known whether men who refuse to be randomized to an exercise trial but are otherwise willing to participate would benefit similarly to men who are randomized. In this study, we will recruit men who are otherwise eligible for our randomized trial but refuse it for one of the reasons above. We will allow these men to choose either supervised group or home-based exercise, and then compare them to the men who are being randomized to the two treatments in 3 important ways. First, are participants similar in terms of personal characteristics, QOL, and fitness levels? Second, do participants respond similarly to exercise in terms of QOL and physical fitness benefits? Third, do participants actually exercise as much as the randomized men? This work will help the research team understand whether there is a need to change the way exercise trials are done in order to be more relevant and wide-reaching for Canadians with a variety of health conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Oct 2017
3 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
First Submitted
Initial submission to the registry
October 19, 2017
CompletedStudy Start
First participant enrolled
October 19, 2017
CompletedFirst Posted
Study publicly available on registry
November 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedAugust 13, 2021
August 1, 2021
2.5 years
October 19, 2017
August 6, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale over time
The FACT-F is a questionnaire that includes 13 items measuring cancer-related fatigue. Total Score Range = 0-52 (higher score = lower fatigue)
Baseline, 3, 6, 12 months
Change in 6 minute walk test (6MWT) scores over time
The 6MWT is a commonly used, validated measure that assesses functional endurance.
Baseline, 3, 6, 12 months
Secondary Outcomes (15)
Change in Functional Assessment of Cancer Therapy-General (FACT-G) scale over time
Baseline, 3, 6, 12 months
Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale over time
Baseline, 3, 6, 12 months
Change in 5 Timed Chair Stand Test over time
Baseline, 3, 6, 12 months
Change in grip strength using a Jamar dynamometer over time
Baseline, 3, 6, 12 months
Change in body composition (fat mass, fat free mass, and body fat percentage) measured via body impedance analysis (BIA) over time
Baseline, 6, 12 months
- +10 more secondary outcomes
Study Arms (2)
Group-supervised
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
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 the supervised group). 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
Moderate intensity mixed-modality exercise 4-5 days per week, with a target of 60 minutes per session.
Eligibility Criteria
You may qualify if:
- men with histologically confirmed PC who are starting or continuing on ADT for at least 6 months
- fluent in English,
- able to provide consent.
You may not qualify if:
- already meeting guidelines for moderate to vigorous physical activity (MVPA)
- conditions that would interfere with ability to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Calgary/Tom Baker Cancer Centre
Calgary, Alberta, Canada
Scarborough and Rouge Hospital
Scarborough Village, Ontario, M1P 2T7, Canada
University Health Network
Toronto, Ontario, M5G 2C4, Canada
Related Publications (1)
Alibhai SMH, Papadopoulos E, Durbano S, Tomlinson G, Mina DS, Ritvo P, Sabiston CM, Matthew AG, Chiarotto J, Sidani S, Culos-Reed SN. Preference-based versus randomized controlled trial in prostate cancer survivors: Comparison of recruitment, adherence, attrition, and clinical outcomes. Front Oncol. 2022 Dec 12;12:1033229. doi: 10.3389/fonc.2022.1033229. eCollection 2022.
PMID: 36578945DERIVED
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
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2017
First Posted
November 8, 2017
Study Start
October 19, 2017
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
August 13, 2021
Record last verified: 2021-08