Cocinar Para su Salud! (Cook for Your Life!)
|Breast Cancer||Behavioral: Cocinar Para Su Salud Program Behavioral: Written dietary recommendations|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 daily intake/servings of fruits and vegetables at 6 months [ Time Frame: 6 months ]Interviewer-administered questionnaire to assess psychosocial parameters, quality of life, and health behaviors
- Change in biomarkers of fruit and vegetable intake at 12 months [ Time Frame: Baseline, 6 months, and 12 months ]Fasting blood will be collected
- Change in molecular biomarkers associated with breast cancer risk of fruit and vegetable intake at 12 months [ Time Frame: Baseline, 6 months, and 12 months ]Fasting blood will be collected
- Prevalence of improved anthropometric measures at 12 months [ Time Frame: Baseline, 6 months, and 12 months ]Physical examination including height, weight, BMI, waist:hip ratio
|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)|
Active Comparator: Arm A
Participants receiving written dietary recommendations for breast cancer survivors (control arm)
Behavioral: 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
Experimental: Arm B
Participants attending Cocinar Para Su Salud Program held over a 12-week period
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.
Other Name: ¡Cocinar para su salud!
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|