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Preference-Based Exercise RCT for Men With PC on ADT (PBExRCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335631
Recruitment Status : Active, not recruiting
First Posted : November 8, 2017
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

Prostate cancer affects 1 in 7 men. Half of these men are treated with androgen deprivation therapy (ADT). ADT slows disease progression and prolongs survival, but it also leads to worse quality of life (QOL), fatigue, loss of strength and fitness, osteoporosis, and diabetes.

The investigators' recent research has shown that individually supervised exercise, supervised group exercise and home-based exercise are equally good at improving these side effects. Now the investigators are doing a larger trial with multiple centres to see whether supervised group or home-based exercise is clinically better and more economical.

A major challenge in such trials is that a significant number of men refuse to be randomized because (a) the participant lives too far from a study centre and cannot come for supervised exercise; or (b) the participant has a strong preference as to which type of exercise program the participant wants to do. Experts have raised concerns that classic randomized trials are too restrictive, selective, and less practical; the study results are less applicable to the real world. Despite its obvious importance, it is not known whether men who refuse to be randomized to an exercise trial but are otherwise willing to participate would benefit similarly to men who are randomized. In this study, we will recruit men who are otherwise eligible for our randomized trial but refuse it for one of the reasons above. We will allow these men to choose either supervised group or home-based exercise, and then compare them to the men who are being randomized to the two treatments in 3 important ways. First, are participants similar in terms of personal characteristics, QOL, and fitness levels? Second, do participants respond similarly to exercise in terms of QOL and physical fitness benefits? Third, do participants actually exercise as much as the randomized men? This work will help the research team understand whether there is a need to change the way exercise trials are done in order to be more relevant and wide-reaching for Canadians with a variety of health conditions.


Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Preference-Based Trial of Two Exercise Delivery Methods in Men With PC on ADT
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group-supervised
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: Exercise
Moderate intensity mixed-modality exercise 4-5 days per week, with a target of 60 minutes per session.

Experimental: Home-based
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: Exercise
Moderate intensity mixed-modality exercise 4-5 days per week, with a target of 60 minutes per session.




Primary Outcome Measures :
  1. Change in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale over time [ Time Frame: Baseline, 3, 6, 12 months ]

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

    Total Score Range = 0-52 (higher score = lower fatigue)


  2. Change in 6 minute walk test (6MWT) scores over time [ Time Frame: Baseline, 3, 6, 12 months ]
    The 6MWT is a commonly used, validated measure that assesses functional endurance.


Secondary Outcome Measures :
  1. Change in Functional Assessment of Cancer Therapy-General (FACT-G) scale over time [ Time Frame: Baseline, 3, 6, 12 months ]

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

    Total Score Range = 0-108 (higher score = higher QOL)


  2. Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale over time [ Time Frame: Baseline, 3, 6, 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.

    Range = 0-48 (higher score = fewer prostate-specific symptoms)


  3. Change in 5 Timed Chair Stand Test over time [ Time Frame: Baseline, 3, 6, 12 months ]
    A common, simple, and validated measure of functional lower body strength.

  4. Change in grip strength using a Jamar dynamometer over time [ Time Frame: Baseline, 3, 6, 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. Change in body composition (fat mass, fat free mass, and body fat percentage) measured via body impedance analysis (BIA) over time [ Time Frame: Baseline, 6, 12 months ]
    Body composition will be measured using bioelectrical impedance analysis (BIA).

  6. Change in fasting lipids over time [ Time Frame: Baseline, 6, 12 months ]
    Fasting lipids will be measured.

  7. Change in blood glucose over time [ Time Frame: Baseline, 6, 12 months ]
    Blood glucose will be measured.

  8. Change in glycated hemoglobin over time [ Time Frame: Baseline, 6, 12 months ]
    Glycated hemoglobin will be measured.

  9. Change in hemoglobin over time [ Time Frame: Baseline, 6, 12 months ]
    Hemoglobin will be measured.

  10. Change in prostate specific antigen (PSA) over time [ Time Frame: Baseline, 6, 12 months ]
    Prostate-specific antigen (PSA) will be measured.

  11. Change in weekly minutes of moderate-vigorous physical activity (MVPA) over time [ Time Frame: Baseline, 3, 6, 12 months ]
    Accelerometry will be used to measure weekly minutes of MVPA as an indicator of adherence at each time point.

  12. Change in Health Care Climate Questionnaire (HCCQ) over time [ Time Frame: Baseline only ]

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

    Range = 0-7 (higher = better)


  13. Change in Behavioral Regulations in Exercise Questionnaire-2 (BREQ-2) over time [ Time Frame: Baseline, 6, 12 months ]

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

    Comprised of 4 subscales:

    External regulation, range = 0-4 (higher = better) Introjected regulation, range = 0-4 (higher = better) Identified regulation, range = 0-4 (higher = better) Intrinsic regulation, range = 0-4 (higher = better)


  14. Change in Psychological Need Support and Frustration Scale - Relatedness Items (PNSF - Relatedness Items) over time [ Time Frame: Baseline, 6, 12 months ]

    The Psychological Need Support and Frustration Scale - Relatedness Items will be used to measure relatedness.

    Total Score Range = 1-5 (higher = better)


  15. Change in Planning, Attitudes, & Barriers scale over time [ Time Frame: Baseline, 6, 12 months ]

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

    Comprised of 11 subscales:

    Attitudes subscale, range = 1-7 (higher = better); Support subscale, range = 1-7 (higher = better); Motivation subscale, range = 1-7 (higher = better); Intentions subscale, range = 1-7 (higher = better); Planning subscale, range = 1-7 (higher = better); Disease/treatment influences subscale, range = 1-7 (higher = better); Disease/treatment frequency subscale, range = 1-7 (higher = better); Life-related influences subscale, range = 1-7 (higher = better); Life-related frequency subscale, range = 1-7 (higher = better); Motivated-related influences subscale, range = 1-7 (higher = better); Motivated-related frequency subscale, range = 1-7 (higher = better) Note: No total score is derived from this questionnaire




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men with histologically confirmed PC who are starting or continuing on ADT for at least 6 months
  • fluent in English,
  • able to provide consent.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335631


Locations
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Canada, Alberta
University of Calgary/Tom Baker Cancer Centre
Calgary, Alberta, Canada
Canada, Ontario
Scarborough and Rouge Hospital
Scarborough, Ontario, Canada, M1P 2T7
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Shabbir MH Alibhai, MD, MSc University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03335631     History of Changes
Other Study ID Numbers: 17-5506
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases