Breast Cancer Clinical Trial
Rx for Better Breast Health
Summary
This randomized controlled trial will test the impact of a patient-navigated, anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing [MI] and tailored newsletters) on obese (body mass index [BMI] 30+), early-stage (0-IIIA) breast cancer survivors compared to a control group.
Full Description
The investigators will recruit English-speaking, early-stage breast cancer survivors (N=200) to a two-arm randomized controlled trial (RCT) involving a 2 (group) by 3 (time) repeated measures design. The intervention will stimulate dietary behavior changes using individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change. Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments. Groups will be compared at baseline and 6- and 12-month follow-up. Dependent measures will include dietary behavior and levels of cancer-associated biomarkers.
Eligibility Criteria
Inclusion Criteria:
Females 18 years or older
Primary diagnosis of breast cancer
Fluency in English
B.M.I. >= 30
Available for follow-up for 12 months
Exclusion Criteria:
Clinical evidence of metastatic disease
Not diagnosed with primary breast cancer
Lack fluency in English
B.M.I. < 30
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There is 1 Location for this study
San Antonio Texas, 78229, United States
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