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Cocinar Para su Salud! (Cook for Your Life!)

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cocinar Para Su Salud Program

Written dietary recommendations

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Healthy meals, Cocinar, Dietary, Dietary Intervention, fruits and vegetables, Cancer survivor, Nutrition

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in daily intake/servings of fruits and vegetables at 6 months

Interviewer-administered questionnaire to assess psychosocial parameters, quality of life, and health behaviors

Secondary Outcome Measures

Change in biomarkers of fruit and vegetable intake at 12 months

Fasting blood will be collected

Change in molecular biomarkers associated with breast cancer risk of fruit and vegetable intake at 12 months

Fasting blood will be collected

Prevalence of improved anthropometric measures at 12 months

Physical examination including height, weight, BMI, waist:hip ratio

Full Information

NCT ID

NCT01414062

First Posted

August 3, 2011

Last Updated

May 19, 2016

Sponsor

Columbia University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01414062

Brief Title

Cocinar Para su Salud! (Cook for Your Life!)

Official Title

Cocinar Para su Salud! (Cook for Your Life!): Implementing Dietary Change Among Hispanic Breast Cancer Survivors

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm B

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Cocinar Para Su Salud Program

Other Intervention Name(s)

¡Cocinar para su salud!

Intervention Description

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

Intervention Name(s)

Written dietary recommendations

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in daily intake/servings of fruits and vegetables at 6 months

Description

Interviewer-administered questionnaire to assess psychosocial parameters, quality of life, and health behaviors

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change in biomarkers of fruit and vegetable intake at 12 months

Description

Fasting blood will be collected

Time Frame

Baseline, 6 months, and 12 months

Title

Change in molecular biomarkers associated with breast cancer risk of fruit and vegetable intake at 12 months

Description

Fasting blood will be collected

Time Frame

Baseline, 6 months, and 12 months

Title

Prevalence of improved anthropometric measures at 12 months

Description

Physical examination including height, weight, BMI, waist:hip ratio

Time Frame

Baseline, 6 months, and 12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heather Greenlee, ND, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32476140

Citation

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.

Results Reference

derived

PubMed Identifier

29904989

Citation

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.

Results Reference

derived

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Cocinar Para su Salud! (Cook for Your Life!)

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