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

NCT ID: NCT01414062

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-11-30

Brief Summary

The primary objectives of this study are to determine the effect of the dietary intervention (Cocinar para su salud! Program) vs. control (standard written nutrition education materials for cancer survivors) in Hispanic breast cancer survivors with early stage breast cancer on 1) daily servings of fruit and vegetable intake from baseline to 6 months; and 2) percent energy from fat and fat-related dietary habits from baseline to 6 months.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm A

Participants receiving written dietary recommendations for breast cancer survivors (control arm)

Group Type: ACTIVE_COMPARATOR

Written dietary recommendations

Intervention Type: BEHAVIORAL

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 New York City (NYC)-based not-for-profit, God's Love We Deliver

Arm B

Participants attending Cocinar Para Su Salud Program held over a 12-week period

Group Type: EXPERIMENTAL

Cocinar Para Su Salud Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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 New York City (NYC)-based not-for-profit, God's Love We Deliver

Intervention Type: BEHAVIORAL

Other Intervention Names

¡Cocinar para su salud!

Eligibility 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 follicle stimulating hormone (FSH)> 20 milli-international units per milliliter (mIU/ml), or history of bilateral oophorectomy.
• Hispanic descent and fluent in Spanish.
• History of histologically-confirmed stage 0, I, II, or III 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 Hemoglobin (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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Dawn L. Hershman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn Hershman, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

Hooper L, Abdelhamid AS, Jimoh OF, Bunn D, Skeaff CM. Effects of total fat intake on body fatness in adults. Cochrane Database Syst Rev. 2020 Jun 1;6(6):CD013636. doi: 10.1002/14651858.CD013636.

Reference Type: DERIVED

PMID: 32476140 (View on PubMed)

Shi Z, Richardson JM, Aycinena AC, Gray HL, Paul R, Koch P, Contento I, Gaffney AO, Greenlee H. Psychosocial mediators of dietary change among Hispanic/Latina breast cancer survivors in a culturally tailored dietary intervention. Psychooncology. 2018 Sep;27(9):2220-2228. doi: 10.1002/pon.4799. Epub 2018 Jul 25.

Reference Type: DERIVED

PMID: 29904989 (View on PubMed)

Other Identifiers

1R21CA152903-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAE9701

Identifier Type: -

Identifier Source: org_study_id