Lifestyle Program (Scalable Nutrition and Physical Activity) for the Improvement of Nutrition and Physical Activity in Stage 0-III Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Testing a Scalable Nutrition and Physical Activity Program for Breast Cancer Survivors: A Dose-Finding Pilot Study

Conditions
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Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage 0 Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8

Intervention / Treatment
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* Behavioral: One Diet and Physical Activity Session
* Other: Electronic (e) Health (eHealth) Communication Intervention
* Behavioral: Twelve Diet and Physical Activity Group Sessions
* Other: Questionnaire Administration
* Other: Quality-of-Life Assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A (low dose nutrition and PA class, eHealth intervention)<br>Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months. | Behavioral: One Diet and Physical Activity Session<br>* Attend 1 remote diet and physical activity session<br>* Other names: Behavioral Treatments;Other: Electronic (e) Health (eHealth) Communication Intervention<br>* Receive eHealth communication intervention<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|
| Experimental: Arm B (high dose nutrition and PA class, eHealth intervention)<br>Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months. | Other: Electronic (e) Health (eHealth) Communication Intervention<br>* Receive eHealth communication intervention<br>Behavioral: Twelve Diet and Physical Activity Group Sessions<br>* Attend 12 remote diet and physical activity sessions in 6 months<br>* Other names: Behavioral Treatments;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accrual rate | Accrual rate will be measured by number of participants randomized during each month of study accrual. | At 6 months | 
| Adherence: Session(s) Attendance | Adherence will be measured by number of online session(s) attended per participant. | At 6 months | 
| Adherence: Responsiveness to eHealth communication | Adherence will be measured by the number of responses to text messages per participant. | At 6 months | 
| Biospecimen collection rate | Biospecimen collection rate will be assessed based on number of biospecimens collected. | At 6 months | 
| Retention | Retention will be measured by the number of completed study assessments per participants. | At 6 months | 
| Acceptability: Questions during exit interview | Acceptability will be measured by questions asking about trial acceptability in the exit questionnaire. | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daily servings of fruits and vegetables per day | Will be assessed by 24-hour dietary recalls. | Baseline to 6 months | 
| Change in minutes per week of moderate-to-vigorous physical activity | Will be assessed by 7-day accelerometer data. | Baseline to 6 months | 
| Change in systemic inflammation | Will be assessed by fasting blood concentrations of high sensitivity C-reactive protein. | Baseline to 6 months | 
| Change in gut barrier permeability | Will be assessed by fasting circulating levels of gut bacterial endotoxin liposaccharide-binding protein. | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer Survivors, Diet, Physical Activity, Breast, eHealth, Nutrition