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

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01414062
• Lead Sponsor: Columbia University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-8-3
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

Inclusion Criteria:<br><br> - Female.<br><br> - Age 21 years or greater. Both pre- and postmenopausal women will be included in this<br> study. Postmenopausal status will be defined as the absence of menses for > 12<br> months, serum follicle stimulating hormone (FSH)> 20 milli-international units per<br> milliliter (mIU/ml), or history of bilateral oophorectomy.<br><br> - Hispanic descent and fluent in Spanish.<br><br> - History of histologically-confirmed stage 0, I, II, or III invasive breast carcinoma<br> without evidence of disease recurrent or metastatic disease at trial entry.<br><br> - Minimum of 3 months since last chemotherapy, biologic therapy (i.e., trastuzumab),<br> radiation therapy, and/or breast surgery. Current use of hormonal therapy is<br> permitted.<br><br> - No uncontrolled diabetes mellitus, defined as Hgb A1C >7.<br><br> - No uncontrolled comorbidities (i.e., hypertension).<br><br> - Currently a non-smoker (rationale: women who smoke are much less likely to engage in<br> healthy lifestyle behaviors, and it is probably more important for these women to<br> stop smoking than it is to change their dietary patterns).<br><br> - Consumes <5 servings of fruits and vegetables per day, as assessed by the Block<br> Fruit and Vegetable Screener.<br><br> - In the pre-contemplation, contemplation, or preparation stage of increasing daily<br> fruit and vegetable intake.<br><br> - Access to functional home phone or cell phone.<br><br> - Willing and able to participate in all study related activities, including study<br> clinic visits, phone interviews, and nutrition counseling sessions.<br><br> - Ability to understand and willingness to sign a written informed consent document<br><br>Exclusion Criteria:<br><br> - Evidence of recurrent or metastatic breast cancer.<br><br> - Uncontrolled diabetes (type 1 or 2), defined as Hemoglobin (Hgb) A1C >7.<br><br> - Uncontrolled or significant co-morbid illness including, but not limited to, active<br> or serious infection requiring intravenous antibiotics; symptomatic congestive heart<br> failure, unstable angina pectoris, cardiac arrhythmia; active gastrointestinal<br> bleeding; active liver disease; active malignancy, except for squamous cell<br> carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ, Stages<br> Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or<br> radiation therapy, Stage Ia Grade 1 adenocarcinoma of the endometrium treated with<br> surgery; patients receiving active chemotherapy or radiotherapy; or psychiatric<br> illness/social situations that would limit compliance with study requirements.<br><br> - Previously participated in Cook For Your Life! classes.<br><br> - Currently active in a dietary change program.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Daily Servings of Fruits and Vegetables

Secondary Outcome Measures

Name	Time	Method
Change in Daily Servings of Fruits and Vegetables;Change in Molecular Biomarkers Associated With Breast Cancer Risk;Change in Weight;Change in Body Mass Index (BMI)