The purpose of this phase II trial is to identify the most effective dose level (number of classes) of a diet and physical activity lifestyle program based on how well it improves diet and physical activity in stage 0-III breast cancer survivors. Study results may provide researchers with information on how to best implement diet and physical activity recommendations among breast cancer survivors.
OUTLINE: Participants are randomized to 1 of 2 arms. ARM A (LOW DOSE): Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months. ARM B (HIGH DOSE): Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
90
Attend 1 remote diet and physical activity session
Receive eHealth communication intervention
Attend 12 remote diet and physical activity sessions in 6 months
Ancillary studies
Ancillary studies
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Accrual rate
Accrual rate will be measured by number of participants randomized during each month of study accrual.
Time frame: At 6 months
Adherence: Session(s) Attendance
Adherence will be measured by number of online session(s) attended per participant.
Time frame: At 6 months
Adherence: Responsiveness to eHealth communication
Adherence will be measured by the number of responses to text messages per participant.
Time frame: At 6 months
Biospecimen collection rate
Biospecimen collection rate will be assessed based on number of biospecimens collected.
Time frame: At 6 months
Retention
Retention will be measured by the number of completed study assessments per participants.
Time frame: At 6 months
Acceptability: Questions during exit interview
Acceptability will be measured by questions asking about trial acceptability in the exit questionnaire.
Time frame: At 6 months
Change in daily servings of fruits and vegetables per day
Will be assessed by 24-hour dietary recalls.
Time frame: Baseline to 6 months
Change in minutes per week of moderate-to-vigorous physical activity
Will be assessed by 7-day accelerometer data.
Time frame: Baseline to 6 months
Change in systemic inflammation
Will be assessed by fasting blood concentrations of high sensitivity C-reactive protein.
Time frame: Baseline to 6 months
Change in gut barrier permeability
Will be assessed by fasting circulating levels of gut bacterial endotoxin liposaccharide-binding protein.
Time frame: Baseline to 6 months
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