Cook for Your Life

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Heather Greenlee, Columbia University
ClinicalTrials.gov Identifier:
NCT01414062
First received: August 3, 2011
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Other: Arm A
Behavioral: Arm B

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Intake of daily servings of fruits and vegetables [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Interviewer-administered 24-hour dietary recall assessment

  • Percent 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

    Interviewer-administered 24-hour dietary recall assessment



Secondary Outcome Measures:
  • Biomarkers of fruit and vegetable intake [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Fasting blood draw

  • 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

  • Anthropometric measures [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Physical examination including blood pressure, height, weight, and waist/hip circumference.


Estimated Enrollment: 70
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Written dietary recommendations 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 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414062

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Heather Greenlee, ND, PhD Columbia University
  More Information

No publications provided

Responsible Party: Heather Greenlee, Assistant Professor, Columbia University
ClinicalTrials.gov Identifier: NCT01414062     History of Changes
Other Study ID Numbers: AAAE9701, 1R21CA152903-01
Study First Received: August 3, 2011
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Breast Cancer
Healthy meals
Cocinar
Dietary
Dietary Intervention
fruits and vegetables
Cancer survivor
Nutrition

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014