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Prostate Cancer Survivors Moving Toward Exercise (PROMOTE) Trial

NCT01410656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 423

Last updated 2018-05-04

No results posted yet for this study

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

Interventions

BEHAVIORAL

Telephone Implementation Intention

Telephone implementation intention counseling

BEHAVIORAL

Self-completed implementation intention

Self-administered implementation intention intervention

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Kerry S Courneya, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01410656 on ClinicalTrials.gov