Skip to main content
OpenTrials
Completed

NCT Number: NCT02834416

ADT Exercise Trial and Economic Analysis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University of Calgary/Tom Baker Cancer Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised Group Exercise

Behavioral

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

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.

Primary outcomes

  1. Functional Assessment of Cancer Therapy-Fatigue (FACT-F)

    Time frame: Every 3 Months for 12 Months

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

  2. 6 Minute Walk Test (6MWT)

    Time frame: Every 3 Months for 12 Months

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

Secondary outcomes

  1. Functional Assessment of Cancer Therapy-General (FACT-G)

    Time frame: Every 3 Months for 12 Months

    The FACT-G is a questionnaire that is well-validated and widely used to measure quality of life (QOL).

  2. Functional Assessment of Cancer Therapy-Prostate (FACT-P)

    Time frame: Every 3 Months for 12 Months

    The FACT-P is a questionnaire that supplements the FACT-G with 12 prostate-specific items covering domains of urinary function, sexual function, pain, and related symptoms.

  3. 5 Times Sit to Stand Test

    Time frame: Every 3 Months for 12 Months

    A common, simple, and validated measure of functional lower body strength.

  4. Grip Strength

    Time frame: Every 3 Months for 12 Months

    Grip strength is a measure of upper body strength and predicts long-term disability and mortality in middle-aged and older adults.

  5. Bioelectrical Impedance Analysis

    Time frame: Every 6 Months for 12 Months

    Body composition will be measured using bioelectrical impedance analysis (BIA).

  6. Waist Circumference and Hip Ratio

    Time frame: Every 6 Months for 12 Months

    Body composition will be measured using waist circumference(WC) and WC:hip ratio, following the standardized Canadian Society for Exercise Physiology - Physical Activity Training for Health (CSEP-PATH) protocol.

  7. Body Mass Index

    Time frame: Every 6 Months for 12 Months

    Body composition will be measured using body mass index (BMI).

  8. Bone Mineral Density (BMD)

    Time frame: Every 6 Months for 12 Months

    Bone mineral density will be measured at lumbar spine, hip, and distal 1/3 radius using dual x-ray absorptiometry (DXA).

  9. Biological Outcomes (blood work)

    Time frame: Every 6 Months for 12 Months

    Fasting lipids, blood glucose, glycated hemoglobin, hemoglobin, prostate-specific antigen (PSA), and testosterone will be measured. Serum banking will also be done for use in future studies.

  10. Sedentary Behaviour

    Time frame: Every 6 Months for 12 Months (unless otherwise specified)

    Time spent in activities that are characterized by an energy expenditure ≤ 1.5 metabolic equivalents and a sitting or reclining posture (sedentary behavior) will be assessed using the Sedentary Behaviour Questionnaire that is used in large cohort studies and has demonstrated evidence of reliability and validity.

  11. Planning, Attitudes, & Barriers scale

    Time frame: Every 6 Months for 12 Months (unless otherwise specified)

    The Planning, Attitudes, & Barriers scale is a validated questionnaire that will be used to assess likelihood of exercise behavior over time.

  12. Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2)

    Time frame: Every 6 Months for 12 Months (unless otherwise specified)

    Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2) is a validated questionnaire that assess predictors of adherence.

  13. Psychological Need Support and Frustration Scale - Relatedness Items

    Time frame: Every 6 Months for 12 Months (unless otherwise specified)

    Relatedness will be assessed using the Psychological Need Support and Frustration Scale - Relatedness Items.

  14. Health Care Climate Questionnaire (HCCQ)

    Time frame: Baseline only

    The Health Care Climate Questionnaire (HCCQ short form) assess participant perceptions of their health care team.

  15. Walkability

    Time frame: Baseline only

    Participant postal codes will be collected to assess neighbourhood walkability (i.e., access to a grocery store within walking distance).

  16. Disease-related Costs

    Time frame: Every 3 Months for 12 Months

    The investigators will collect economically relevant data about health status using preference-based (utility) instruments (European Quality of Life Five Dimensions Questionnaire, EQ-5D). Productivity losses and out-of-pocket expenditures, in addition to hospitalization, drug co-pay, and health visit data will be gathered using a patient questionnaire.

  17. Exercise Adherence

    Time frame: Every 3 Months for 12 Months

    Both accelerometry and the Godin Leisure Time Exercise Questionnaire will be used as a measure of adherence at each time point. Both measures will provide a validated measure of physical activity.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Scarborough Rouge Hospital
  • Southlake Health
  • Tom Baker Cancer Centre

Registry information

Official study title

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

Acronym: ADTExRCT

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2016
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.