Rx for Better Breast Health

The University of Texas System (UT)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Dietary Control; Behavioral: Dietary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02279303

HSC20140150H

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

Dietary Intervention

Experimental group

Description:

Participants will receive 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.

Treatment:

Behavioral: Dietary Intervention

Dietary Control

Active Comparator group

Description:

Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments.

Treatment:

Behavioral: Dietary Control