Rx for Better Breast Health

NCT02279303 | Completed DMC

• 1 other identifier: HSC20140150H
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (6)

• Achieve USDA-recommended dietary intake based on five major food groups

  The USDA has published dietary intake guidelines for 5 major food groups. We will create a composite score ("yes" vs. "no") describing whether ss achieve designated levels of dietary intake for all five food groups. We will compare proportions of study and control women achieving this target at 12-month follow-up controlling for baseline values.

  12 months

• Intervention versus Control group comparison of circulating Adipose Stromal Cells (ASCs) at follow-up

  We will compare participant (intervention) versus control levels of circulating Adipose Stromal Cells (ASCs) at 12-month follow-up. Participant levels of ASCs will be significantly lower than controls, controlling for baseline values.

  12 months

• Comparison of Interleukin (IL) pro-inflammatory biomarkers

  We will compare participant versus control levels of Interleukins IL3, IL6, IL8 at 12-month follow-up. Participant levels of IL3, IL6, and IL8 will be significantly lower than controls, controlling for baseline values.

  12 months

• Comparison of Interleukin (IL) anti-inflammatory biomarkers

  We will compare participant versus control levels of Interleukin IL10 at 12-month follow-up. Participant levels of IL10 will be significantly lower than controls, controlling for baseline values.

  12 months

• Comparison of C-Reactive Protein (CRP)

  We will compare participant versus control levels of C-Reactive Protein (CRP) at 12-month follow-up. Participant levels of CRP will be significantly lower than controls, controlling for baseline values.

  12 months

• Comparison of Tumor Necrosis Factor-alpha (TNF-alpha)

  We will compare participant versus control levels of Tumor Necrosis Factor-alpha (TNF-alpha) at 12-month follow-up. Participant levels of TNF-alpha will be significantly lower than controls, controlling for baseline values.

  12 months

Study Arms (2)

Dietary Intervention

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.

Behavioral: Dietary Intervention

Dietary Control

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.

Behavioral: Dietary Control

Interventions

Dietary Intervention BEHAVIORAL

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

Dietary Control BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females 18 years or older
• Primary diagnosis of breast cancer
• Fluency in English
• B.M.I. \>= 30
• Available for follow-up for 12 months

You may not qualify if:

• Clinical evidence of metastatic disease
• Not diagnosed with primary breast cancer
• Lack fluency in English
• B.M.I. \< 30

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Amelie Ramirez, DRPH

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 31, 2014
• Study Start: April 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (1)