Lifestyle Program (Scalable Nutrition and Physical Activity) for the Improvement of Nutrition and Physical Activity in Stage 0-III Breast Cancer Survivors
Study Details
Study Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm A (low dose nutrition and PA class, eHealth intervention) 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
Attend 1 remote diet and physical activity session
Other Names:
Other: Electronic (e) Health (eHealth) Communication Intervention
Receive eHealth communication intervention
Other: Questionnaire Administration
Ancillary studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
| Experimental: Arm B (high dose nutrition and PA class, eHealth intervention) 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
Receive eHealth communication intervention
Behavioral: Twelve Diet and Physical Activity Group Sessions
Attend 12 remote diet and physical activity sessions in 6 months
Other Names:
Other: Questionnaire Administration
Ancillary studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Accrual rate [At 6 months]
Accrual rate will be measured by number of participants randomized during each month of study accrual.
- 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.
- Acceptability: Questions during exit interview [At 6 months]
Acceptability will be measured by questions asking about trial acceptability in the exit questionnaire.
Secondary Outcome Measures
- Change in daily servings of fruits and vegetables per day [Baseline to 6 months]
Will be assessed by 24-hour dietary recalls.
- 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.
Eligibility Criteria
Criteria
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%
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No uncontrolled hypertension per Seattle Cancer Care Alliance (SCCA) standard of care
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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)
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Access to phone for study contacts
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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)
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Willing and able to attend the online session(s) on Saturdays, or via online accessed videos, for up to 12 sessions in 6 months
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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
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Willing and able to complete all study activities for 6 months after randomization
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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
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Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of performance status score of 0 or 1 for performance status.
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Signed physician approval for diet change and physical activity
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Able to understand and willing to sign written informed electronic (e) consent in English
Exclusion Criteria:
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Participants must not be active smokers within the past 30 days.
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Women must not be pregnant at time of enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
- Breast Cancer Research Foundation
Investigators
- Principal Investigator: Nancy E Davidson, Fred Hutch/University of Washington Cancer Consortium
- Principal Investigator: Heather Greenlee, Fred Hutch/University of Washington Cancer Consortium
Study Documents (Full-Text)
More Information
Publications
None provided.- RG1006427
- NCI-2019-07643
- 10335