Rx for Better Breast Health

NCT ID: NCT02279303

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type 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 Control

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

Group Type ACTIVE_COMPARATOR

Dietary Control

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Susan G. Komen Breast Cancer Foundation

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Amelie Ramirez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amelie Ramirez, DRPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC20140150H

Identifier Type: -

Identifier Source: org_study_id

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