Clinical trial NCT01414062: Cook for Your Life!: Implementing Dietary Change Among Hispanic Breast Cancer Survivors
Official title: Cocinar Para su Salud! (Cook for Your Life!): Implementing Dietary Change Among Hispanic Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Healthy meals
Cocinar
Dietary
Dietary Intervention
fruits and vegetables
Cancer survivor
Nutrition
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-08-11
Enrollment: 82
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Daily Servings of Fruits and Vegetables
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Daily Servings of Fruits and Vegetables
timeFrame: Baseline and 12 months
measure: Change in Molecular Biomarkers Associated With Breast Cancer Risk
timeFrame: Baseline and 12 months
measure: Change in Weight
timeFrame: Baseline and 12 months
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Dawn Hershman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.