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Prostate CancerPhase 3ADTExRCTNCT02834416

ADT Exercise Trial and Economic Analysis

A Phase 3 study testing Supervised Group Exercise and Home Based Exercise in people with Prostate Cancer, run by University Health Network, Toronto at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Supervised Group Exercise and Home Based Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
4 sitesCanada
Study dates
Aug 2016to 31 Mar 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • University of Calgary/Tom Baker Cancer Centre

    Calgary, Alberta, T2N 1N4

  • Southlake Regional Health Centre

    Newmarket, Ontario

  • Scarborough and Rouge Hospital

    Toronto, Ontario, M1P 2T7

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G2C4

Other trials in Canada

About this study

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

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.

Read more

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
Being tested
Supervised Group Exercise, Home Based Exercise
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supervised Group ExerciseBehavioural

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

  • Home Based ExerciseBehavioural

    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.

Study groups in NCT02834416
Study groupRoleWhat they receive
Group-SupervisedExperimentalThis 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.
Receives: Behavioral: Supervised Group Exercise
Home-BasedExperimentalThe 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.
Receives: Behavioral: Home Based Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Every 3 Months for 12 Months

  2. 6 Minute Walk Test (6MWT)

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

    Measured: Every 3 Months for 12 Months

Secondary outcomes (17)

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

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

    Measured: Every 3 Months for 12 Months

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

    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.

    Measured: Every 3 Months for 12 Months

  3. 5 Times Sit to Stand Test

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

    Measured: Every 3 Months for 12 Months

  4. Grip Strength

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

    Measured: Every 3 Months for 12 Months

  5. Bioelectrical Impedance Analysis

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

    Measured: Every 6 Months for 12 Months

  6. Waist Circumference and Hip Ratio

    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.

    Measured: Every 6 Months for 12 Months

  7. Body Mass Index

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

    Measured: Every 6 Months for 12 Months

  8. Bone Mineral Density (BMD)

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

    Measured: Every 6 Months for 12 Months

  9. Biological Outcomes (blood work)

    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.

    Measured: Every 6 Months for 12 Months

  10. Sedentary Behaviour

    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.

    Measured: Every 6 Months for 12 Months (unless otherwise specified)

  11. Planning, Attitudes, & Barriers scale

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

    Measured: Every 6 Months for 12 Months (unless otherwise specified)

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

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

    Measured: Every 6 Months for 12 Months (unless otherwise specified)

  13. Psychological Need Support and Frustration Scale - Relatedness Items

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

    Measured: Every 6 Months for 12 Months (unless otherwise specified)

  14. Health Care Climate Questionnaire (HCCQ)

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

    Measured: Baseline only

  15. Walkability

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

    Measured: Baseline only

  16. Disease-related Costs

    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.

    Measured: Every 3 Months for 12 Months

  17. Exercise Adherence

    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.

    Measured: Every 3 Months for 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion31 Mar 2020
  4. Study completion31 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02834416
Sponsor's protocol ID
14-8158-CE
Acronym
ADTExRCT
Status last verified
Apr 2021
First submitted
2 Jun 2016
Last updated
13 Apr 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37976654

  • 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.

    PubMed 30352568

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Supervised Group Exercise and Home Based Exercise in people with Prostate Cancer, run by University Health Network, Toronto at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Assessment of Cancer Therapy-Fatigue (FACT-F) (time frame: Every 3 Months for 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02834416, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.

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