Clinical trial NCT02834416: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Tom Baker Cancer Centre
name: Southlake Regional Health Centre
name: Scarborough Rouge Hospital
First posted: 2016-07-15
Enrollment: 38
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An a priori decision was made to not include additional covariates in the ANCOVA model due to a smaller than anticipated sample size. Only trial centre, length of ADT, and baseline 6MWT will be included in the model.

In addition, we have modified the wear time criteria for accelerometry from 600 minutes of wear time to 500 minutes of wear time. This allows for the inclusion of more participant data and more accurately reflects the clinical nature of this population.

Amendment date: 17-Sep-20
Primary purpose: SUPPORTIVE_CARE

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 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 Southlake Regional Health Centre in Newmarket, and Scarborough and Rouge Hospital - Centenary Site in Scarborough. 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.


Eligibility criteria: Inclusion Criteria:

* men with histologically confirmed PC who are starting or continuing on ADT for at least 6 months or who are in an androgen-deprived (or castrate) state for the duration of the intervention
* fluent in English
* able to provide consent
* close to a study centre

Exclusion Criteria:

* already meeting guidelines for moderate to vigorous physical activity (MVPA) - conditions that would interfere with ability to participate

Primary outcomes:
measure: Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
timeFrame: Every 3 Months for 12 Months
measure: 6 Minute Walk Test (6MWT)
timeFrame: Every 3 Months for 12 Months
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy-General (FACT-G)
timeFrame: Every 3 Months for 12 Months
measure: Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame: Every 3 Months for 12 Months
measure: 5 Times Sit to Stand Test
timeFrame: Every 3 Months for 12 Months
measure: Grip Strength
timeFrame: Every 3 Months for 12 Months
measure: Bioelectrical Impedance Analysis
timeFrame: Every 6 Months for 12 Months
measure: Waist Circumference and Hip Ratio
timeFrame: Every 6 Months for 12 Months
measure: Body Mass Index
timeFrame: Every 6 Months for 12 Months
measure: Bone Mineral Density (BMD)
timeFrame: Every 6 Months for 12 Months
measure: Biological Outcomes (blood work)
timeFrame: Every 6 Months for 12 Months
measure: Sedentary Behaviour
timeFrame: Every 6 Months for 12 Months (unless otherwise specified)
measure: Planning, Attitudes, & Barriers scale
timeFrame: Every 6 Months for 12 Months (unless otherwise specified)
measure: Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2)
timeFrame: Every 6 Months for 12 Months (unless otherwise specified)
measure: Psychological Need Support and Frustration Scale - Relatedness Items
timeFrame: Every 6 Months for 12 Months (unless otherwise specified)
measure: Health Care Climate Questionnaire (HCCQ)
timeFrame: Baseline only
measure: Walkability
timeFrame: Baseline only
measure: Disease-related Costs
timeFrame: Every 3 Months for 12 Months
measure: Exercise Adherence
timeFrame: Every 3 Months for 12 Months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary/Tom Baker Cancer Centre
state: Alberta
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Scarborough and Rouge Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References:
citation: Alibhai SMH, Ritvo P, Santa Mina D, Sabiston C, Krahn M, Tomlinson G, Matthew A, Lukka H, Warde P, Durbano S, O'Neill M, Culos-Reed SN. Protocol for a phase III RCT and economic analysis of two exercise delivery methods in men with PC on ADT. BMC Cancer. 2018 Oct 23;18(1):1031. doi: 10.1186/s12885-018-4937-x.