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Rx for Better Breast Health

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ClinicalTrials.gov Identifier: NCT02279303
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Amelie Ramirez, The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Dietary Intervention Behavioral: Dietary Control Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prescription for Better Breast Health
Study Start Date : April 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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: 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.
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.




Primary Outcome Measures :
  1. Achieve USDA-recommended dietary intake based on five major food groups [ Time Frame: 12 months ]
    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.

  2. Intervention versus Control group comparison of circulating Adipose Stromal Cells (ASCs) at follow-up [ Time Frame: 12 months ]
    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.

  3. Comparison of Interleukin (IL) pro-inflammatory biomarkers [ Time Frame: 12 months ]
    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.

  4. Comparison of Interleukin (IL) anti-inflammatory biomarkers [ Time Frame: 12 months ]
    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.

  5. Comparison of C-Reactive Protein (CRP) [ Time Frame: 12 months ]
    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.

  6. Comparison of Tumor Necrosis Factor-alpha (TNF-alpha) [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279303


Locations
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United States, Texas
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Susan G. Komen Breast Cancer Foundation
Investigators
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Principal Investigator: Amelie Ramirez, DRPH The University of Texas Health Science Center at San Antonio

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Responsible Party: Amelie Ramirez, Principal Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02279303    
Other Study ID Numbers: HSC20140150H
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018