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

NCT01414062 | Completed Results DMC

• 2 other identifiers: AAAE97011R21CA152903-01
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Healthy meals; Cocinar; Dietary; Dietary Intervention; fruits and vegetables; Cancer survivor; Nutrition

Outcome Measures

Primary Outcomes (1)

• Change in Daily Servings of Fruits and Vegetables

  The change in participants intake and fruits and vegetables at 6 months (compared to baseline) as determined by diet recalls collected by an interviewer administered questionnaire.

  Baseline and 6 months

Secondary Outcomes (4)

• Change in Daily Servings of Fruits and Vegetables

  Baseline and 12 months

• Change in Molecular Biomarkers Associated With Breast Cancer Risk

  Baseline and 12 months

• Change in Weight

  Baseline and 12 months

• Change in Body Mass Index (BMI)

  Baseline and 12 months

Study Arms (2)

Arm A

ACTIVE COMPARATOR

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

Behavioral: Written dietary recommendations

Arm B

EXPERIMENTAL

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

Behavioral: Cocinar Para Su Salud Program

Interventions

Cocinar Para Su Salud Program 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.

Also known as: ¡Cocinar para su salud!

Arm B

Written dietary recommendations 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 A

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  PMID: 32476140 DERIVED

• 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.

  PMID: 29904989 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dawn Hershman, MD, MS
• Organization: Columbia University Irving Medical Center

dlh23@cumc.columbia.edu

212-342-4580

Study Officials

• Dawn Hershman, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 11, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: November 1, 2016
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Locations

US (1)