Cocinar Para su Salud! (Cook for Your Life!)
Cocinar Para su Salud! (Cook for Your Life!)
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. The Primary Aims are to determine the effect of the
 dietary intervention (¡Cocinar para su salud! program) vs. control (standard written
 nutrition education materials for cancer survivors) on 1) daily servings of fruit/vegetable,
 and 2) daily servings of fat intake from baseline to 6 months. The investigators hypothesize
 that the dietary intervention will result in a larger increase of fruit and vegetable intake
 and a larger reduction of fat intake, when compared to the control group. Secondary Aims are
 to determine the effect of the dietary intervention vs. control on 1) biomarkers of fruit and
 vegetable intake, molecular biomarkers associated with breast cancer risk, and anthropometric
 measures at 6 and 12 months; 2) fruit/vegetable and fat intake at 12 months; 3) mediators of
 dietary change, including readiness to change, outcome expectations, perceived self efficacy,
 food and nutrition skills, self regulation skills, and barriers to adherence; and 4) changes
 in quality of life and anxiety/depression at 6 and 12 months.
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 intervention.

 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
 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 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.