Prostate Cancer Survivors Moving Toward Exercise (PROMOTE) Trial (PROMOTE)

Prostate Cancer Survivors MOving Toward Exercise (PROMOTE) Trial

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Telephone Implementation Intention; Behavioral: Self-completed implementation intention

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.

• Study Type: Interventional
• Enrollment (Actual): 423
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2H9
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Prostate cancer survivors
• at least 18 years old
• proficient in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard PA Recommendation; Received the standard physical activity recommendation.
Experimental: Telephone Implementation Intention; Behavioural Telephone Assisted Implementation Intention Intervention	Behavioral: Telephone Implementation Intention; Telephone implementation intention counseling
Experimental: Self-completed implementation intention; Self-administered implementation intention intervention.	Behavioral: Self-completed implementation intention; Self-administered implementation intention intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 1 month, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life/ physical functioning	Looking for change in the FACT-P and SF-36.	baseline, 3 months
fatigue	Looking for change in the FACIT-F	baseline, 3 months

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Kerry S Courneya, PhD, University of Alberta

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: August 4, 2011
• First Posted (Estimate): August 5, 2011

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Survivors
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: RES-0006611