Status:
COMPLETED
Cook for Your Life!: Implementing Dietary Change Among Hispanic Breast Cancer Survivors
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
21+ years
Phase:
NA
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 sur...
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 diagnosi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01414062
Start Date
January 1 2011
End Date
November 1 2016
Last Update
August 23 2024
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032