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

Cocinar Para su Salud! (Cook for Your Life!): Implementing Dietary Change Among Hispanic Breast Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Cocinar Para Su Salud Program; Behavioral: Written dietary recommendations

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A; Participants receiving written dietary recommendations for breast cancer survivors (control arm)	Behavioral: Written dietary recommendations; Standard of care: one on one meetings with study staff to receive compiled written information on dietary recommendations for breast cancer survivors produced by the New York City (NYC)-based not-for-profit, God's Love We Deliver
Experimental: Arm B; Participants attending Cocinar Para Su Salud Program held over a 12-week period	Behavioral: Cocinar Para Su Salud Program; A series of 9 Cocinar Para Su Salud intervention sessions held over a 12-week period. The 12-week intervention period will be divided into 3 groups: motivation, action, and environment. Each topic will use a nutrition roundtable, food shopping field trip, and a cooking class to teach pertinent points, in order to enable participants to progress from the precontemplation, contemplation, and preparation stages of change to the action and maintenance stages.; Other Names: ¡Cocinar para su salud!

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Daily Servings of Fruits and Vegetables	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.	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Daily Servings of Fruits and Vegetables	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.	Baseline and 12 months
Change in Molecular Biomarkers Associated With Breast Cancer Risk	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.	Baseline and 12 months
Change in Weight	The change in weight from baseline to 12 months.	Baseline and 12 months
Change in Body Mass Index (BMI)	The change in BMI from baseline to 12 months.	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Dawn Hershman, MD, MS, Columbia University

Publications and helpful links

General Publications

• Hooper L, Abdelhamid AS, Jimoh OF, Bunn D, Skeaff CM. Effects of total fat intake on body fatness in adults. Cochrane Database Syst Rev. 2020 Jun 1;6(6):CD013636. doi: 10.1002/14651858.CD013636.
• Shi Z, Richardson JM, Aycinena AC, Gray HL, Paul R, Koch P, Contento I, Gaffney AO, Greenlee H. Psychosocial mediators of dietary change among Hispanic/Latina breast cancer survivors in a culturally tailored dietary intervention. Psychooncology. 2018 Sep;27(9):2220-2228. doi: 10.1002/pon.4799. Epub 2018 Jul 25.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: August 3, 2011
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (Estimated): August 11, 2011

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Nutrition; Cancer survivor; Dietary Intervention; fruits and vegetables; Dietary; Healthy meals; Cocinar
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: AAAE9701; 1R21CA152903-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No