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

Memorial University of Newfoundland

Status: Completed

Conditions: Breast Cancer; Physical Activity; Quality of Life; Fatigue; Prostate Cancer

Treatments: Behavioral: Two-time implementation intention; Behavioral: Physical Activity Materials; Behavioral: Sham Comparator; Behavioral: One-time implementation intention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02321358

20141338-HK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Two-time implementation intention

Experimental group

Description:

Group will receive physical activity materials along with the implementation intention intervention and a booster again six weeks following.

Treatment:

Behavioral: Two-time implementation intention

Behavioral: Physical Activity Materials

One-time implementation intention

Active Comparator group

Description:

Group will receive physical activity materials along with the implementation intention intervention.

Treatment:

Behavioral: One-time implementation intention

Behavioral: Physical Activity Materials

Sham Comparator Group

Sham Comparator group

Description:

Group will receive Canada's Food Guide which contains a small amount of physical activity information.

Treatment:

Behavioral: Sham Comparator