Prostate Cancer Survivors Moving Toward Exercise (PROMOTE) Trial

NCT01410656 | Completed

• 1 other identifier: RES-0006611
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Survivors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Quality of life/ physical functioning

  baseline, 3 months

• fatigue

  baseline, 3 months

Study Arms (3)

Standard PA Recommendation

NO INTERVENTION

Received the standard physical activity recommendation.

Telephone Implementation Intention

EXPERIMENTAL

Behavioural Telephone Assisted Implementation Intention Intervention

Behavioral: Telephone Implementation Intention

Self-completed implementation intention

EXPERIMENTAL

Self-administered implementation intention intervention.

Behavioral: Self-completed implementation intention

Interventions

Telephone Implementation Intention BEHAVIORAL

Telephone implementation intention counseling

Telephone Implementation Intention

Self-completed implementation intention BEHAVIORAL

Self-administered implementation intention intervention

Self-completed implementation intention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2H9, Canada

Location

Related Publications (2)

• 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.

  PMID: 28656468 DERIVED

• 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.

  PMID: 23783829 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kerry S Courneya, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: August 5, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

CA (1)