MedPath

Cook for Your Life!: Implementing Dietary Change Among Hispanic Breast Cancer Survivors

Not Applicable
Completed
Conditions
Breast Cancer
Interventions
Behavioral: Written dietary recommendations
Behavioral: Cocinar Para Su Salud Program
Registration Number
NCT01414062
Lead Sponsor
Columbia University
Brief Summary

The primary objectives of this study are to determine the effect of the dietary intervention (Cocinar para su salud! Program) vs. control (standard written nutrition education materials for cancer survivors) in Hispanic breast cancer survivors with early stage breast cancer on 1) daily servings of fruit and vegetable intake from baseline to 6 months; and 2) percent energy from fat and fat-related dietary habits from baseline to 6 months.

Detailed Description

Hispanic women are 20% more likely to die of breast cancer than non Hispanic white women who are diagnosed at a similar age and stage. One reason for this disparity may be differences in post diagnosis dietary behaviors. In order to reduce this disparity, and to improve overall survivorship, culturally appropriate dietary interventions that teach women how to eat a diet high in fruits and vegetables and low in saturated fat need to be developed for Hispanic breast cancer survivors. The investigators propose to conduct a randomized controlled study (n=70, 35 per arm) to test the effects of the ¡Cocinar para su salud! program on changing dietary behaviors among Hispanic breast cancer survivors who have recently completed treatment. The ¡Cocinar para su salud! program is a 12 week course that provides hands on education and instruction in nutrition education, meal preparation, and food shopping in a group setting. All participants will be followed for a total of 12 months, have clinical assessments at baseline, 6 months, and 12 months, and monthly telephone contacts using motivational interview techniques.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
82
Inclusion Criteria
  • Female.
  • Age 21 years or greater. Both pre- and postmenopausal women will be included in this study. Postmenopausal status will be defined as the absence of menses for > 12 months, serum follicle stimulating hormone (FSH)> 20 milli-international units per milliliter (mIU/ml), or history of bilateral oophorectomy.
  • Hispanic descent and fluent in Spanish.
  • History of histologically-confirmed stage 0, I, II, or III invasive breast carcinoma without evidence of disease recurrent or metastatic disease at trial entry.
  • Minimum of 3 months since last chemotherapy, biologic therapy (i.e., trastuzumab), radiation therapy, and/or breast surgery. Current use of hormonal therapy is permitted.
  • No uncontrolled diabetes mellitus, defined as Hgb A1C >7.
  • No uncontrolled comorbidities (i.e., hypertension).
  • Currently a non-smoker (rationale: women who smoke are much less likely to engage in healthy lifestyle behaviors, and it is probably more important for these women to stop smoking than it is to change their dietary patterns).
  • Consumes <5 servings of fruits and vegetables per day, as assessed by the Block Fruit and Vegetable Screener.
  • In the pre-contemplation, contemplation, or preparation stage of increasing daily fruit and vegetable intake.
  • Access to functional home phone or cell phone.
  • Willing and able to participate in all study related activities, including study clinic visits, phone interviews, and nutrition counseling sessions.
  • Ability to understand and willingness to sign a written informed consent document
Read More
Exclusion Criteria
  • Evidence of recurrent or metastatic breast cancer.
  • Uncontrolled diabetes (type 1 or 2), defined as Hemoglobin (Hgb) A1C >7.
  • Uncontrolled or significant co-morbid illness including, but not limited to, active or serious infection requiring intravenous antibiotics; symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia; active gastrointestinal bleeding; active liver disease; active malignancy, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy, Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery; patients receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements.
  • Previously participated in Cook For Your Life! classes.
  • Currently active in a dietary change program.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm AWritten dietary recommendationsParticipants receiving written dietary recommendations for breast cancer survivors (control arm)
Arm BCocinar Para Su Salud ProgramParticipants attending Cocinar Para Su Salud Program held over a 12-week period
Primary Outcome Measures
NameTimeMethod
Change in Daily Servings of Fruits and VegetablesBaseline and 6 months

The change in participants intake and fruits and vegetables at 6 months (compared to baseline) as determined by diet recalls collected by an interviewer administered questionnaire.

Secondary Outcome Measures
NameTimeMethod
Change in WeightBaseline and 12 months

The change in weight from baseline to 12 months.

Change in Daily Servings of Fruits and VegetablesBaseline and 12 months

The change in participants intake and fruits and vegetables at 12 months (compared to baseline) as determined by diet recalls collected by an interviewer administered questionnaire.

Change in Body Mass Index (BMI)Baseline and 12 months

The change in BMI from baseline to 12 months.

Change in Molecular Biomarkers Associated With Breast Cancer RiskBaseline and 12 months

Fasting blood will be collected at baseline and 12 months to determine whether the change in diet changes participants' biomarkers. Specifically, the change in DNA methylation (a chemical reaction in the body in which a small molecule called a methyl group gets added to DNA) will be measured against the increase in dietary factors.

Trial Locations

Locations (1)

Columbia University Medical Center

🇺🇸

New York, New York, United States

© Copyright 2025. All Rights Reserved by MedPath