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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Cocinar Para su Salud! (Cook for Your Life!): Implementing Dietary Change Among Hispanic Breast Cancer Survivors|
- Change in intake of daily servings of fruits and vegetables [ Time Frame: 6 months ] [ Designated as safety issue: No ]Interviewer-administered questionnaire to assess psychosocial parameters, quality of life, and health behaviors
- Change in biomarkers of fruit and vegetable intake [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Fasting blood draw
- Change in molecular biomarkers associated with breast cancer risk of fruit and vegetable intake [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Fasting blood draw
- Change in anthropometric measures [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Physical examination including blood pressure, height, weight, and waist/hip circumference.
- Percent of energy from fat and fat-related dietary habits [ Time Frame: 6 months ] [ Designated as safety issue: No ]Interviewer-administered questionnaire to assess psychosocial parameters, quality of life, and health behaviors
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Written dietary recommendations
Control arm: Standard written nutrition education materials for cancer survivors (Arm A).
Other: Arm A
Participants randomized to Arm A will meet one on one 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
Experimental: Cocinar Para Su Salud Program
¡Cocinar para su salud! (Arm B only). Participants randomized to Arm B will be scheduled to attend a series of 9 ¡Cocinar para su salud! intervention sessions held over a 12-week period.
Behavioral: Arm B
Participants randomized to Arm B will be scheduled to attend 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414062
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Heather Greenlee, ND, PhD||Columbia University|