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Prostate CancerPhase 2ADT Ex RCTNCT02046837

An Exercise Trial and Economic Analysis in Men With Prostate Cancer

A Phase 2 study testing Supervised 1:1 exercise, Supervised group exercise and Home-based exercise in people with Prostate Cancer, run by University Health Network, Toronto at 2 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 1:1 exercise, Supervised group exercise and Home-based exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
2 sitesCanada
Study dates
Nov 2013to Jan 2018
Phase
Phase 2
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

  • confirmed prostate cancer
  • starting or continuing on ADT for at least 6 months
  • fluent in English
  • able to provide consent
  • live close to a study centre
  • screened with the Physical Activity Readiness Questionnaire (PAR-Q+ or PARmed-X) to ensure safe exercise participation OR receive medical clearance by attending physician

Who cannot join

  • already meeting guidelines for moderate to vigorous physical activity (MVPA) as defined by the Canadian Physical Activity Guidelines (greater than or equal to 150 minutes of MVPA per week)
  • conditions that would interfere with ability to participate

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • University of Calgary/Tom Baker Cancer Centre

    Calgary, Alberta, T2N 1N4

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5T 2M9

Other trials in Canada

About this study

Official title: A Pilot RCT and Economic Analysis of Three 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; (b) home-based supported; and (c) 1:1 supervised in-centre 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

The investigators will ask men with PC on ADT that are being treated at either Princess Margaret Cancer Centre in Toronto or the Tom Baker Cancer Centre in Calgary to participate in the study. When a patient agrees to participate, he will be randomly placed in 1 of the 3 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 1:1 exercise, Supervised group exercise, Home-based exercise
Keywords
Prostate cancer, Exercise, Elderly, Quality of life, Fatigue, Physical fitness, Adherence, Cost-effectiveness
Medical subject headings
Prostatic Neoplasms, Motor Activity, Fatigue

What participants receive

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

  • Supervised 1:1 exerciseBehavioural

    The exercise program will be delivered in a personal training (1:1) format by a certified exercise specialist.

  • 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 NCT02046837
Study groupRoleWhat they receive
Supervised 1:1 exerciseExperimentalThis intervention arm will include 3 one-on-one, supervised sessions per week for 6 months with a certified exercise specialist. 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 1:1 exercise
Supervised group exerciseExperimentalThis 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-based exerciseExperimentalThe 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 supervised groups). 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. Change from baseline in health-related quality of life (QOL) at 3, 6, 9, and 12 months

    Measured by the Functional Assessment of Cancer Therapy-General (FACT-G), health-related QOL refers to those aspects of QOL that relate a person's health to their physical, functional, psychological, and social well-being. The FACT-G is a well-validated and widely used QOL measure. It can be completed in 8-10 minutes and has published normative data.

    Measured: Every 3 months for 1 year

Secondary outcomes (10)

  1. Change from baseline in quality of life (QOL) at 3, 6, 9, and 12 months

    Supplementing the assessment of health-related QOL, prostate-specific QOL will be measured with the FACT-P. The FACT-P contains 12 prostate-specific items covering domains of urinary function, sexual function, pain, and related symptoms. It is well-validated and used in multiple prior exercise trials.

    Measured: Every 3 months for 1 year

  2. Change from baseline in fatigue at 3, 6, 9, and 12 months

    The FACT-Fatigue (FACT-F), includes 13 items measuring cancer-related fatigue. It has excellent reliability and validity. Fatigue is a common symptom in men on ADT and has been shown to benefit from exercise.

    Measured: Every 3 months for 1 year

  3. Change from baseline in aerobic fitness (VO2peak) at 3, 6, 9, and 12 months

    Aerobic fitness will be assessed using a treadmill-based graded exercise test (modified Bruce protocol) to maximal exertion. Standard test termination criteria apply.

    Measured: Every 3 months for 1 year

  4. Change from baseline in musculoskeletal fitness at 3, 6, 9, and 12 months

    Musculoskeletal fitness will be assessed using a sit-to-stand test, a common, simple, and validated measure of functional lower body strength.

    Measured: Every 3 months for 1 year

  5. Change from baseline in grip strength at 3, 6, 9, and 12 months

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

    Measured: Every 3 months for 1 year

  6. Change from baseline in body composition at 6 and 12 months

    Body composition will be assessed via bioelectrical impedance analysis (BIA), waist circumference (WC), WC:hip ratio, and BMI, following the standardized Canadian Society for Exercise Physiology protocol.

    Measured: Every 6 months for 1 year

  7. Change from baseline in bone mineral density at 12 months

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

    Measured: Baseline and 1 year.

  8. Change from baseline in biological outcomes at 6 and 12 months

    Insulin sensitivity and blood lipid profiles have been shown to be negatively affected by ADT. To examine the effect of exercise on these metabolic outcomes, fasting lipids and blood glucose, in addition to PSA level, will be assessed. Serum banking will also be done for use in future studies.

    Measured: Every 6 months for 1 year

  9. Change from baseline in adherence predictors at 3, 6, 9, and 12 months

    We will use a social ecological approach to assess factors at three related levels using the following validated measures: Exosystem Measures: Neighborhood Environment Walkability Scale: Short Form (NEWS-A); Mesosystem Measures: Health Care Climate Questionnaire (HCCQ short form) and Relatedness to Others in Physical Activity scale; Microsystem Measures: Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2) and a Planning, Attitudes, \& Barriers scale. Time spent in activities that are characterized by an energy expenditure ≤ 1.5 metabolic equivalents and a sitting or reclining posture 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 3 months for 1 year

  10. Change from baseline in cost-effectiveness at 3, 6, 9, and 12 months

    We will collect economically relevant data about health status using preference-based (utility) instruments (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 1 year

Timeline

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

  1. First posted28 Jan 2014 (estimated)
  2. Study startNov 2013
  3. Primary completionJan 2018
  4. Study completionJan 2018

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 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02046837
Sponsor's protocol ID
UHN ADT Ex 01
Acronym
ADT Ex RCT
Status last verified
Apr 2021
First submitted
20 Jan 2014
Last updated
13 Apr 2021
Results posted
No
Data monitoring committee
No

Publications

  • Papadopoulos E, Leach HJ, Tomlinson G, Durbano S, Danyluk JM, Sabiston CM, Mina DS, Alibhai SMH, Culos-Reed SN. Factors predicting gains in moderate-to-vigorous physical activity in prostate cancer survivors on androgen deprivation therapy. Support Care Cancer. 2022 Nov;30(11):9011-9018. doi: 10.1007/s00520-022-07300-2. Epub 2022 Aug 10.

    PubMed 35948848

  • Alibhai SMH, Santa Mina D, Ritvo P, Tomlinson G, Sabiston C, Krahn M, Durbano S, Matthew A, Warde P, O'Neill M, Timilshina N, Segal R, Culos-Reed N. A phase II randomized controlled trial of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy. BMC Cancer. 2019 Jan 3;19(1):2. doi: 10.1186/s12885-018-5189-5.

    PubMed 30606137

  • Alibhai SM, Santa Mina D, Ritvo P, Sabiston C, Krahn M, Tomlinson G, Matthew A, Segal R, Warde P, Durbano S, O'Neill M, Culos-Reed N. A phase II RCT and economic analysis of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy. BMC Cancer. 2015 Apr 25;15:312. doi: 10.1186/s12885-015-1316-8.

    PubMed 25908311

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Supervised 1:1 exercise, Supervised group exercise and Home-based exercise in people with Prostate Cancer, run by University Health Network, Toronto at 2 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 6 inclusion and 2 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 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change from baseline in health-related quality of life (QOL) at 3, 6, 9, and 12 months (time frame: Every 3 months for 1 year). 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 NCT02046837, which also lists 3 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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