Cocinar Para su Salud! (Cook for Your Life!)

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01414062
• Other study ID #: AAAE9701
• Secondary ID: 1R21CA152903-01
• Status: Active, not recruiting
• Phase: N/A
• First received: August 3, 2011
• Last updated: May 19, 2016
• Start date: January 2011
• Est. completion date: September 2016

Study information

• Verified date: May 2016
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Cocinar Para Su Salud Program
A series of 9 Cocinar Para Su Salud intervention sessions held over a 12-week period. The 12-week intervention period will be divided into 3 groups: motivation, action, and environment. Each topic will use a nutrition roundtable, food shopping field trip, and a cooking class to teach pertinent points, in order to enable participants to progress from the precontemplation, contemplation, and preparation stages of change to the action and maintenance stages.
• Written dietary recommendations
Standard of care: one on one meetings with study staff to receive compiled written information on dietary recommendations for breast cancer survivors produced by the NYC-based not-for-profit, God's Love We Deliver

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in daily intake/servings of fruits and vegetables at 6 months	Interviewer-administered questionnaire to assess psychosocial parameters, quality of life, and health behaviors	6 months	No
Secondary	Change in biomarkers of fruit and vegetable intake at 12 months	Fasting blood will be collected	Baseline, 6 months, and 12 months	No
Secondary	Change in molecular biomarkers associated with breast cancer risk of fruit and vegetable intake at 12 months	Fasting blood will be collected	Baseline, 6 months, and 12 months	No
Secondary	Prevalence of improved anthropometric measures at 12 months	Physical examination including height, weight, BMI, waist:hip ratio	Baseline, 6 months, and 12 months	No