Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments dietary intervention, dietary control
Sponsor The University of Texas Health Science Center at San Antonio
Collaborator Susan G. Komen Breast Cancer Foundation
Start date April 2013
End date December 2016
Trial size 160 participants
Trial identifier NCT02279303, HSC20140150H

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
dietary intervention
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.
(Active Comparator)
Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments.
dietary control
Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments.

Primary Outcomes

Measure
Achieve USDA-recommended dietary intake based on five major food groups
time frame: 12 months
Intervention versus Control group comparison of circulating Adipose Stromal Cells (ASCs) at follow-up
time frame: 12 months
Comparison of Interleukin (IL) pro-inflammatory biomarkers
time frame: 12 months
Comparison of Interleukin (IL) anti-inflammatory biomarkers
time frame: 12 months
Comparison of C-Reactive Protein (CRP)
time frame: 12 months
Comparison of Tumor Necrosis Factor-alpha (TNF-alpha)
time frame: 12 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Prescription for Better Breast Health
Principal investigator Amelie Ramirez, DRPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio.