Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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%
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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

90

Study ID:

NCT04200482

Recruitment Status:

Completed

Sponsor:

Fred Hutchinson Cancer Center

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There is 1 Location for this study

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Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

90

Study ID:

NCT04200482

Recruitment Status:

Completed

Sponsor:


Fred Hutchinson Cancer Center

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