Trial of a Behavior Change Intervention to Increase Aerobic and Resistance Exercise and Quality of Life in Older Prostate and Breast Cancer Survivors (OutPACE)

October 20, 2020 updated by: Erin McGowan, Memorial University of Newfoundland

Randomized Controlled Trial of a Behavior Change Intervention to Increase Aerobic and Resistance Exercise and Quality of Life in Older Prostate and Breast Cancer Survivors: The OutPACE Trial

This trial is a three-armed randomized controlled trial which will explore the utility of an implementation intention intervention on aerobic and resistance exercise in older (60+) prostate and breast cancer survivors and improving quality of life. It is expected that those in the experimental groups will report greater increases in their physical activity, resulting in greater improvements in their quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recruitment

Potential participants will be contacted by the Newfoundland and Labrador Cancer registry. They will be given a brief explanation of the study will be asked to consent to a mail-out questionnaire from the registry. The questionnaire will contain a cover letter explaining the study in more detail along with informed consent. If the participant wishes to continue in the study, they will return the questionnaire to the research team, who will contact them from this point.

Participants will also be recruited through presentations at local support groups as well as advertisements in local papers and posters at local hospitals and recreation centers.

Power Analysis

According to G*Power a sample of 40 prostate and breast cancer survivors per group (n=120) is needed to detect a medium effect size (d= .50) on our primary outcome (i.e., PA) with a power of 0.80, at a p-level of 0.05. We expect a 20% attrition rate, based on previous research (McGowan, North, & Courneya, 2013; Vallance, Courneya, Plotnikoff, Yasui, & Mackey, 2007) therefore we will attempt to recruit a sample of 150 breast and prostate cancer survivors, which would allow for 50 participants per group.

Data Analysis

Analyses of covariance will be used to examine group differences on our primary outcome (i.e., PA minute/week) at month 1 and month 3, and secondary outcomes (e.g., QoL) at month 3. Additional analyses of covariance will be run to explore the group differences on sedentary behaviour, and light, moderate and vigorous minutes of activity/week at month 1 and month 3. Medical (e.g., comorbidities, months since diagnosis) and demographic (e.g., marital status, age, BMI) will be tested as possible moderators of PA behaviour change.

If we experience a large proportion of missing data multiple imputation techniques in SPSS will be used to replace missing values. Otherwise, a last outcome carried forward approach will be used.

The relationships between self-reported PA and QoL, and objectively measured PA and QoL in older breast and prostate cancer survivors will be explored. To examine this, differences in QoL between participants in the two PA categories (i.e., meeting PA guidelines and not meeting PA guidelines) will be tested using analysis of variance (ANOVA). These analyses will be repeated using analysis of covariance (ANCOVA) to control for the demographic and medical variables that had statistically significant associations with the QoL.

The relationship between objectively measured PA and self-reported PA will be explored using a two-way mixed intraclass correlation coefficient to calculate the level of absolute agreement between the two types of measurements.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1C 5S7
        • School of Human Kinetics and Recreation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 60 years old or older
  • Breast or prostate cancer survivor
  • Completed surgery, radiation and/or chemotherapy
  • Proficient in English
  • Living in the greater St. John's, NL area; participants are asked to meet researchers at the university
  • Have an interest in becoming more active or learning about physical activity

Exclusion Criteria:

  • Those with contraindications to exercise
  • Participants will be asked about other existing diseases and if they have been told by their doctor to avoid certain activities. Some may be asked to consult with physician before taking part

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Two-time implementation intention
Group will receive physical activity materials along with the implementation intention intervention and a booster again six weeks following.
Behavioral: Two-time implementation intention
Will be given intervention and booster at six weeks
Behavioral: Physical Activity Materials
Thera-Bands, instructional DVD and exercise handout, instructional stretching handout, CSEP Physical activity guidelines.
Active Comparator: One-time implementation intention
Group will receive physical activity materials along with the implementation intention intervention.
Behavioral: Physical Activity Materials
Thera-Bands, instructional DVD and exercise handout, instructional stretching handout, CSEP Physical activity guidelines.
Behavioral: One-time implementation intention
Will only be given the intervention once
Sham Comparator: Sham Comparator Group
Group will receive Canada's Food Guide which contains a small amount of physical activity information.
Behavioral: Sham Comparator
Canada's Food Guide for Healthy Eating will be provided. This contains a small amount of physical activity information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self-Reported Physical Activity
Time Frame: Baseline, one month follow-up, three month follow-up
Using Godin's Leisure Score Index, participants will be asked how much physical activity they took part in over the past seven days. Data from each time point will be analyzed and compared to determine change.
Baseline, one month follow-up, three month follow-up
Change in Objectively Measured Physical Activity
Time Frame: Baseline, one month follow-up, three month follow-up
Participants will wear an accelerometer (ActiGraph GT3X) for seven days to assess their activity. Data from each time point will be analyzed and compared to determine change.
Baseline, one month follow-up, three month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fatigue
Time Frame: Baseline, one month follow-up, three month follow-up
Will be assessed using the FACIT-F questionnaire. Data from each time point will be analyzed and compared to determine change.
Baseline, one month follow-up, three month follow-up
Change in Quality of Life
Time Frame: Baseline, one month follow-up, three month follow-up
Will be assessed using the short-form 36 scale (SF-36) and Functional Assessment of Cancer Therapy (FACT) questionnaire, specific to cancer type (FACT-Breast or FACT-Prostate). Data from each time point will be analyzed and compared to determine change.
Baseline, one month follow-up, three month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial University of Newfoundland

Collaborators

Mitacs

Investigators

  • Principal Investigator: Erin L McGowan, Ph.D, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 16, 2014

First Posted (Estimate)

December 22, 2014

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20141338-HK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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