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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02321358
Acronym
OutPACE
Enrollment
30
Registered
2014-12-22
Start date
2014-09-30
Completion date
2018-09-30
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Behavior Change, Objectively Measured Physical Activity, Survivorship

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.

Interventions

BEHAVIORALTwo-time implementation intention

Will be given intervention and booster at six weeks

BEHAVIORALOne-time implementation intention

Will only be given the intervention once

BEHAVIORALSham Comparator

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

BEHAVIORALPhysical Activity Materials

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

Sponsors

Mitacs
CollaboratorINDUSTRY
Memorial University of Newfoundland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Self-Reported Physical ActivityBaseline, one month follow-up, three month follow-upUsing 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.
Change in Objectively Measured Physical ActivityBaseline, one month follow-up, three month follow-upParticipants 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.

Secondary

MeasureTime frameDescription
Change in FatigueBaseline, one month follow-up, three month follow-upWill be assessed using the FACIT-F questionnaire. Data from each time point will be analyzed and compared to determine change.
Change in Quality of LifeBaseline, one month follow-up, three month follow-upWill 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026