ADT Exercise Trial and Economic Analysis

NCT02834416 | Completed Phase 3

• 1 other identifier: 14-8158-CE
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Functional Assessment of Cancer Therapy-Fatigue (FACT-F)

  The FACT-F is a questionnaire that includes 13 items measuring cancer-related fatigue.

  Every 3 Months for 12 Months

• 6 Minute Walk Test (6MWT)

  The 6MWT is a commonly used, validated measure that assesses functional endurance.

  Every 3 Months for 12 Months

Secondary Outcomes (17)

• Functional Assessment of Cancer Therapy-General (FACT-G)

  Every 3 Months for 12 Months

• Functional Assessment of Cancer Therapy-Prostate (FACT-P)

  Every 3 Months for 12 Months

• 5 Times Sit to Stand Test

  Every 3 Months for 12 Months

• Grip Strength

  Every 3 Months for 12 Months

• Bioelectrical Impedance Analysis

  Every 6 Months for 12 Months

Study Arms (2)

Group-Supervised

EXPERIMENTAL

This 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.

Behavioral: Supervised Group Exercise

Home-Based

EXPERIMENTAL

The 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.

Behavioral: Home Based Exercise

Interventions

Supervised Group Exercise BEHAVIORAL

The exercise program will be delivered in a group format (4-8 participants per group) by a certified exercise specialist.

Group-Supervised

Home Based Exercise BEHAVIORAL

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.

Home-Based

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Tom Baker Cancer Centre: collaborator
• Southlake Regional Health Centre: collaborator
• Scarborough Rouge Hospital: collaborator

Study Sites (4)

University of Calgary/Tom Baker Cancer Centre

Calgary, Alberta, T2N 1N4, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Location

Scarborough and Rouge Hospital

Toronto, Ontario, M1P 2T7, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G2C4, Canada

Location

Related Publications (2)

• Alibhai SMH, Papadopoulos E, Mina DS, Ritvo P, Tomlinson G, Sabiston CM, Durbano S, Bremner KE, Chiarotto J, Matthew A, Warde P, O'Neill M, Culos-Reed SN. Home-based versus supervised group exercise in men with prostate cancer on androgen deprivation therapy: A randomized controlled trial and economic analysis. J Geriatr Oncol. 2024 Jan;15(1):101646. doi: 10.1016/j.jgo.2023.101646. Epub 2023 Nov 15.

  PMID: 37976654 DERIVED

• 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.

  PMID: 30352568 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: July 15, 2016
• Study Start: August 1, 2016
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)