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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Fatigue, Quality of Life, Physical Activity, Breast Cancer, Prostate Cancer

Intervention / Treatment
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* Behavioral: Two-time implementation intention
* Behavioral: One-time implementation intention
* Behavioral: Sham Comparator
* Behavioral: Physical Activity Materials


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-Reported Physical Activity | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Objectively Measured Physical Activity, Survivorship, Behavior Change