Prostate Cancer Survivors Moving Toward Exercise (PROMOTE) Trial (PROMOTE)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telephone Implementation Intention
Self-completed implementation intention
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring Survivors
Eligibility Criteria
Inclusion Criteria:
- Prostate cancer survivors
- at least 18 years old
- proficient in English
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Standard PA Recommendation
Telephone Implementation Intention
Self-completed implementation intention
Arm Description
Received the standard physical activity recommendation.
Behavioural Telephone Assisted Implementation Intention Intervention
Self-administered implementation intention intervention.
Outcomes
Primary Outcome Measures
Change in Physical activity Levels From Baseline to Month 1 and Month 3
Measured by the Leisure score index. Looking for change in Physical Activity levels from baseline to month 1 and month 3 follow-ups.
Secondary Outcome Measures
Quality of life/ physical functioning
Looking for change in the FACT-P and SF-36.
fatigue
Looking for change in the FACIT-F
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01410656
Brief Title
Prostate Cancer Survivors Moving Toward Exercise (PROMOTE) Trial
Acronym
PROMOTE
Official Title
Prostate Cancer Survivors MOving Toward Exercise (PROMOTE) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of the study is to determine the effects of an implementation intention intervention on physical activity (PA) behaviour in prostate cancer survivors. Secondary aims are to (a) compare the effects of a telephone-assisted implementation intention intervention against a self-administered implementation intention intervention and a standard recommendation group on physical activity behaviour and (b) document the effects of these interventions on quality of life (QoL), fatigue, symptom management, and physical functioning.
Hypotheses: Evidence exists that an implementation intention intervention can lead to significant improvements in PA levels and that regular PA has been shown to improve QoL, fatigue levels, manage symptoms and improve physical functioning in cancer survivors'. As such, the following hypotheses were generated: (1) prostate cancer survivors exposed to the researcher-assisted implementation intention intervention will have higher PA levels at the 1- and 3-month follow-ups compared to the self-completed implementation intention intervention and the standard recommendation group; (2) prostate cancer survivors in the researcher-assisted implementation intention intervention will show significant improvements in QoL, fatigue levels, symptom management, and physical functioning compared to the self-completed implementation intention intervention and the standard recommendation group at the 1- and 3-month follow-up; and (3) prostate cancer survivors in the self-completed implementation intention intervention will have higher PA levels, and better improvements in QoL, fatigue levels, symptom management, and physical functioning compared to the standard recommendation group at the 1- and 3-month follow-ups.
Detailed Description
BACKGROUND:
Prostate cancer remains the most frequently diagnosed cancer among Canadian men, with an estimated 24,600 men being diagnosed in 2010. In Alberta specifically, roughly 2,500 men will be diagnosed with prostate cancer, and 440 men will die of the disease in 2010 (Canadian Cancer Society, 2011). Improvements in the treatment of prostate cancer has reduced tumour growth and improved survival rates, however, it has also been associated with significant negative changes in cancer survivors' quality of life, physical functioning, body fat percentage and fatigue levels that may persist for years following treatment. One behavioural strategy that has been consistently shown to combat these negative side effects and enhance psychosocial and physical well-being in prostate cancer survivors is physical activity. Unfortunately it has been established that physical activity levels decline significantly from pre-diagnosis to during treatment and may never regain pre-diagnosis levels; thus it is important to test novel, innovative and inexpensive ways to increase physical activity patterns in prostate cancer survivors.
PURPOSE:
The primary purpose of the study is to determine the effects of an implementation intention intervention on physical activity behaviour in prostate cancer survivors. Secondary aims are to (a) compare the effects of a telephone-assisted implementation intention intervention against a self-administered implementation intention intervention and a standard recommendation group on physical activity behaviour and (b) document the effects of these interventions on quality of life, fatigue, symptom management, and physical functioning.
METHODS:
A three-arm randomized controlled trial for prostate cancer survivors will be performed through the Alberta Cancer Registry. To obtain a sample of at least 300 participants, 1500 prostate cancer survivors will be contacted in the initial mail-out. Following the initial mail-out prostate cancer survivors agreeing to participate in the study will be randomized to one of the three conditions. All groups will receive a written physical activity recommendation, as well as the 2008 Physical Activity Guidelines. In addition to the physical activity materials, participants in the telephone-assisted and self-administered groups will be asked to complete an implementation intention intervention. Finally, the telephone-assisted group will receive a 10-20 minute telephone call to assist them with the completion of implementation intention intervention. Measures at baseline (i.e., initial mail-out) will include self-reported physical activity, demographic, health and medical factors, quality of life, fatigue, physical functioning. Follow-up at month 1 and 3 following the intervention will include self-reported physical activity, quality of life, fatigue and physical function measures.
SUMMARY:
This mail-out study will offer insight into the effects of an implementation intention intervention on physical activity levels in an understudied cancer population, and further explore the effect of physical activity as part of the usual care recommended for the treatment of prostate cancer on quality of life, fatigue and symptom management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Survivors
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
423 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard PA Recommendation
Arm Type
No Intervention
Arm Description
Received the standard physical activity recommendation.
Arm Title
Telephone Implementation Intention
Arm Type
Experimental
Arm Description
Behavioural Telephone Assisted Implementation Intention Intervention
Arm Title
Self-completed implementation intention
Arm Type
Experimental
Arm Description
Self-administered implementation intention intervention.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Implementation Intention
Intervention Description
Telephone implementation intention counseling
Intervention Type
Behavioral
Intervention Name(s)
Self-completed implementation intention
Intervention Description
Self-administered implementation intention intervention
Primary Outcome Measure Information:
Title
Change in Physical activity Levels From Baseline to Month 1 and Month 3
Description
Measured by the Leisure score index. Looking for change in Physical Activity levels from baseline to month 1 and month 3 follow-ups.
Time Frame
baseline, 1 month, 3 months
Secondary Outcome Measure Information:
Title
Quality of life/ physical functioning
Description
Looking for change in the FACT-P and SF-36.
Time Frame
baseline, 3 months
Title
fatigue
Description
Looking for change in the FACIT-F
Time Frame
baseline, 3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Prostate cancer survivors
at least 18 years old
proficient in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry S Courneya, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2H9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28656468
Citation
McGowan EL, Fuller D, Cutumisu N, North S, Courneya KS. The role of the built environment in a randomized controlled trial to increase physical activity among men with prostate cancer: the PROMOTE trial. Support Care Cancer. 2017 Oct;25(10):2993-2996. doi: 10.1007/s00520-017-3798-1. Epub 2017 Jun 27.
Results Reference
derived
PubMed Identifier
23783829
Citation
McGowan EL, North S, Courneya KS. Randomized controlled trial of a behavior change intervention to increase physical activity and quality of life in prostate cancer survivors. Ann Behav Med. 2013 Dec;46(3):382-93. doi: 10.1007/s12160-013-9519-1.
Results Reference
derived
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Prostate Cancer Survivors Moving Toward Exercise (PROMOTE) Trial
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