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

NCT ID: NCT02321358

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-09-30

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Two-time implementation intention

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

Group Type: EXPERIMENTAL

Two-time implementation intention

Intervention Type: BEHAVIORAL

Will be given intervention and booster at six weeks

Physical Activity Materials

Intervention Type: BEHAVIORAL

Thera-Bands, instructional DVD and exercise handout, instructional stretching handout, CSEP Physical activity guidelines.

One-time implementation intention

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

Group Type: ACTIVE_COMPARATOR

One-time implementation intention

Intervention Type: BEHAVIORAL

Will only be given the intervention once

Physical Activity Materials

Intervention Type: BEHAVIORAL

Thera-Bands, instructional DVD and exercise handout, instructional stretching handout, CSEP Physical activity guidelines.

Sham Comparator Group

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

Group Type: SHAM_COMPARATOR

Sham Comparator

Intervention Type: BEHAVIORAL

Canada's Food Guide for Healthy Eating will be provided. This contains a small amount of physical activity information.

Interventions

Two-time implementation intention

Will be given intervention and booster at six weeks

Intervention Type: BEHAVIORAL

One-time implementation intention

Will only be given the intervention once

Intervention Type: BEHAVIORAL

Sham Comparator

Canada's Food Guide for Healthy Eating will be provided. This contains a small amount of physical activity information.

Intervention Type: BEHAVIORAL

Physical Activity Materials

Thera-Bands, instructional DVD and exercise handout, instructional stretching handout, CSEP Physical activity guidelines.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mitacs

INDUSTRY

Sponsor Role: collaborator

Memorial University of Newfoundland

OTHER

Sponsor Role: lead

Responsible Party

Erin McGowan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erin L McGowan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

School of Human Kinetics and Recreation

St. John's, Newfoundland and Labrador, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 23783829 (View on PubMed)

Vallance JK, Courneya KS, Plotnikoff RC, Yasui Y, Mackey JR. Randomized controlled trial of the effects of print materials and step pedometers on physical activity and quality of life in breast cancer survivors. J Clin Oncol. 2007 Jun 10;25(17):2352-9. doi: 10.1200/JCO.2006.07.9988.

Reference Type: BACKGROUND

PMID: 17557948 (View on PubMed)

Other Identifiers

20141338-HK

Identifier Type: -

Identifier Source: org_study_id