Prostate Cancer Survivors Moving Toward Exercise (PROMOTE) Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Alberta.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT01410656
First received: July 19, 2011
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Behavioral: Telephone Implementation Intention
Behavioral: Self-completed implementation intention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prostate Cancer Survivors MOving Toward Exercise (PROMOTE) Trial

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Change in Physical activity Levels From Baseline to Month 1 and Month 3 [ Time Frame: baseline, 1 month, 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
    Looking for change in the FACT-P and SF-36.

  • fatigue [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
    Looking for change in the FACIT-F


Enrollment: 423
Study Start Date: May 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prostate cancer survivors
  • at least 18 years old
  • proficient in English
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410656

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2H9
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Kerry S Courneya, PhD University of Alberta
  More Information

No publications provided by University of Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Kerry Courneya, University of Alberta
ClinicalTrials.gov Identifier: NCT01410656     History of Changes
Other Study ID Numbers: RES-0006611
Study First Received: July 19, 2011
Last Updated: August 4, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Survivors

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014