Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage 0 Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8
Conditions
Keywords
Breast Cancer Survivors, Diet, eHealth, Nutrition, Physical Activity, Breast
Brief summary
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.
Detailed description
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.
Interventions
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
Sponsors
Study design
Eligibility
Inclusion criteria
* Previous diagnosis of stage 0-III breast cancer in the past 10 years at the time of enrollment * No evidence of recurrent or metastatic disease * No uncontrolled diabetes mellitus defined as glycosylated hemoglobin (Hgb A1C) \> 8% * No uncontrolled hypertension per Seattle Cancer Care Alliance (SCCA) standard of care * At least 60 days post final chemotherapy, biologic therapy, or radiation therapy and/or surgery. Current use of endocrine therapy is permitted (e.g., tamoxifen and aromatase inhibitors) * Access to phone for study contacts * Access to smartphone, tablet, or computer and internet to attend online session(s) and receive study electronic eHealth communication (text messages and access to website) * Willing and able to attend the online session(s) on Saturdays, or via online accessed videos, for up to 12 sessions in 6 months * Successfully complete all run-in activities, including at-home and over the phone assessments, 7 days of collecting physical activity data via accelerometer, and providing blood and stool sample * Willing and able to complete all study activities for 6 months after randomization * Participants must consume \< 5 servings of fruits and vegetables per day and/or engage in \< 150 minutes per week of moderate to vigorous physical activity, as assessed by brief questionnaires * Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of performance status score of 0 or 1 for performance status. * Signed physician approval for diet change and physical activity * Able to understand and willing to sign written informed electronic (e) consent in English
Exclusion criteria
* Participants must not be active smokers within the past 30 days. * Women must not be pregnant at time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability: Questions during exit interview | At 6 months | Acceptability will be measured by questions asking about trial acceptability in the exit questionnaire. |
| Adherence: Session(s) Attendance | At 6 months | Adherence will be measured by number of online session(s) attended per participant. |
| Adherence: Responsiveness to eHealth communication | At 6 months | Adherence will be measured by the number of responses to text messages per participant. |
| Biospecimen collection rate | At 6 months | Biospecimen collection rate will be assessed based on number of biospecimens collected. |
| Retention | At 6 months | Retention will be measured by the number of completed study assessments per participants. |
| Accrual rate | At 6 months | Accrual rate will be measured by number of participants randomized during each month of study accrual. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in minutes per week of moderate-to-vigorous physical activity | Baseline to 6 months | Will be assessed by 7-day accelerometer data. |
| Change in systemic inflammation | Baseline to 6 months | Will be assessed by fasting blood concentrations of high sensitivity C-reactive protein. |
| Change in gut barrier permeability | Baseline to 6 months | Will be assessed by fasting circulating levels of gut bacterial endotoxin liposaccharide-binding protein. |
| Change in daily servings of fruits and vegetables per day | Baseline to 6 months | Will be assessed by 24-hour dietary recalls. |
Countries
United States