Promoting Activity in Cancer Survivors (PACES)
Status
Completed
Conditions
Breast Cancer
Physical Activity
Treatments
Behavioral: Active living counseling
Behavioral: Supervised exercise sessions
Behavioral: Facility access
Behavioral: Self-monitoring (Fitbit)
Behavioral: Physical activity education
Details and patient eligibility
About
A randomized multi-component physical activity intervention for breast cancer survivors.
Full description
The research project is a study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors. Individuals meeting inclusion/exclusion criteria will be randomized to one of sixteen intervention groups for the 6 months. Intervention components will include print-based education, self-monitoring, Active Living counseling, supervised exercise sessions, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points during the intervention (Weeks 13 and 25). Changes in physical activity will be assessed for each intervention group.
Enrollment
355 patients
Sex
Female
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- breast cancer survivors between 3 months and 5 years post-treatment
- report <150 minutes of moderate-to-vigorous physical activity (MVPA) on the GPAQ
- physically able to engage in physical activity
Exclusion criteria
- medical condition contraindicating physical activity participation
- cognitively unable to give informed consent
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
355 participants in 16 patient groups
Group 1
Experimental group
Description:
Physical activity education
Treatment:
Behavioral: Physical activity education
Group 2
Experimental group
Description:
Physical activity education and facility access
Treatment:
Behavioral: Physical activity education
Behavioral: Facility access
Group 3
Experimental group
Description:
Physical activity education and supervised exercise sessions
Treatment:
Behavioral: Physical activity education
Behavioral: Supervised exercise sessions
Group 4
Experimental group
Description:
Physical activity education and self-monitoring (Fitbit)
Treatment:
Behavioral: Self-monitoring (Fitbit)
Behavioral: Physical activity education
Group 5
Experimental group
Description:
Physical activity education and active living counseling
Treatment:
Behavioral: Physical activity education
Behavioral: Active living counseling
Group 6
Experimental group
Description:
Physical activity education, facility access, and supervised exercise sessions
Treatment:
Behavioral: Physical activity education
Behavioral: Facility access
Behavioral: Supervised exercise sessions
Group 7
Experimental group
Description:
Physical activity education, facility access, and self-monitoring (Fitbit)
Treatment:
Behavioral: Self-monitoring (Fitbit)
Behavioral: Physical activity education
Behavioral: Facility access
Group 8
Experimental group
Description:
Physical activity education, facility access, and active living counseling
Treatment:
Behavioral: Physical activity education
Behavioral: Facility access
Behavioral: Active living counseling
Group 9
Experimental group
Description:
Physical activity education, supervised exercise sessions, and self-monitoring (Fitbit)
Treatment:
Behavioral: Self-monitoring (Fitbit)
Behavioral: Physical activity education
Behavioral: Supervised exercise sessions
Group 10
Experimental group
Description:
Physical activity education, supervised exercise sessions, and active living counseling
Treatment:
Behavioral: Physical activity education
Behavioral: Active living counseling
Behavioral: Supervised exercise sessions
Group 11
Experimental group
Description:
Physical activity education, self-monitoring (Fitbit), and active living counseling
Treatment:
Behavioral: Self-monitoring (Fitbit)
Behavioral: Physical activity education
Behavioral: Active living counseling
Group 12
Experimental group
Description:
Physical activity education, facility access, supervised exercise sessions, and self-monitoring (Fitbit)
Treatment:
Behavioral: Self-monitoring (Fitbit)
Behavioral: Physical activity education
Behavioral: Facility access
Behavioral: Supervised exercise sessions
Group 13
Experimental group
Description:
Physical activity education, facility access, supervised exercise sessions, and active living counseling
Treatment:
Behavioral: Physical activity education
Behavioral: Facility access
Behavioral: Active living counseling
Behavioral: Supervised exercise sessions
Group 14
Experimental group
Description:
Physical activity education, facility access, self-monitoring (Fitbit), and active living counseling
Treatment:
Behavioral: Self-monitoring (Fitbit)
Behavioral: Physical activity education
Behavioral: Facility access
Behavioral: Active living counseling
Group 15
Experimental group
Description:
Physical activity education, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
Treatment:
Behavioral: Self-monitoring (Fitbit)
Behavioral: Physical activity education
Behavioral: Active living counseling
Behavioral: Supervised exercise sessions
Group 16
Experimental group
Description:
Physical activity education, facility access, supervised exercise sessions, self-monitoring (Fitbit), and active living counseling
Treatment:
Behavioral: Self-monitoring (Fitbit)
Behavioral: Physical activity education
Behavioral: Facility access
Behavioral: Active living counseling
Behavioral: Supervised exercise sessions
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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