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

21 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

This trial is a randomized, controlled 2-arm study of a 3-month dietary change counseling
and instruction intervention among Hispanic breast cancer survivors (n=70, 35 per arm). The
study is comparing Arm A: standard of care written dietary recommendations for cancer
survivors, with Arm B: the 12-week ¡Cocinar para su salud!. ¡Cocinar para su salud! will
provide hands-on education and instruction to Hispanic breast cancer survivors in nutrition
education, food shopping, and meal preparation in a group setting. Participants will be
followed for a total of 12 months, have clinical assessments at baseline, 6 months, and 12
months, and will have monthly telephone contacts using motivational interviewing. The
primary endpoint is at 6 months because the investigators hypothesize that it will take
participants at least 3 months to adapt some of the dietary behaviors taught in the 3-month

A total of 70 women with a history of histologically-confirmed early stage breast cancer
will be randomized to Arm A or Arm B. Assuming an accrual rate of approximately 2-4
participants per month, the investigators expect to complete enrollment within 24 months.

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 FSH > 20 mIU/ml, or history of bilateral oophrectomy.

- Hispanic descent and fluent in Spanish.

- History of histologically-confirmed stage 0, I, II, or III (see Appendix I for TNM
staging system) 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

- 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 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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Intake of daily servings of fruits and vegetables

Outcome Description:

Interviewer-administered 24-hour dietary recall assessment

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Heather Greenlee, ND, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

July 2014

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Healthy meals
  • Cocinar
  • Dietary
  • Dietary Intervention
  • fruits and vegetables
  • Cancer survivor
  • Nutrition
  • Breast Neoplasms



Columbia University Medical Center New York, New York  10032