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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA152903-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Participants receiving written dietary recommendations for breast cancer survivors (control arm) |
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| Arm B | Experimental | Participants attending Cocinar Para Su Salud Program held over a 12-week period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Servings of Fruits and Vegetables | The change in participants intake and fruits and vegetables at 12 months (compared to baseline) as determined by diet recalls collected by an interviewer administered questionnaire. | Baseline and 12 months |
| Change in Molecular Biomarkers Associated With Breast Cancer Risk |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Hershman, MD, MS | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32476140 | Derived | 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. | |
| 29904989 | 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. |
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82 participants were enrolled and 12 withdrew, resulting in 70 participants being randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Control) | Participants receiving written dietary recommendations for breast cancer survivors (control arm) 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-based not-for-profit, God's Love We Deliver |
| FG001 | Arm B (Cocinar Para Su Salud Program) | Participants attending Cocinar Para Su Salud Program held over a 12-week period 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Participants receive written dietary recommendations for breast cancer survivors (control arm) 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | daily servings of fruits and vegetables | Baseline and 6 months |
|
Data was collected at the following time periods: 3 months, 6 months, and 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (Control) | Participants receiving written dietary recommendations for breast cancer survivors (control arm) 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Hershman, MD, MS | Columbia University Irving Medical Center | 212-342-4580 | dlh23@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
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| 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 |
|
Fasting blood will be collected at baseline and 12 months to determine whether the change in diet changes participants' biomarkers. Specifically, the change in DNA methylation (a chemical reaction in the body in which a small molecule called a methyl group gets added to DNA) will be measured against the increase in dietary factors. |
| Baseline and 12 months |
| Change in Weight | The change in weight from baseline to 12 months. | Baseline and 12 months |
| Change in Body Mass Index (BMI) | The change in BMI from baseline to 12 months. | Baseline and 12 months |
| Family Disapproval |
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| Withdrawal by Subject |
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| BG001 |
| Arm B |
Participants attend the Cocinar Para Su Salud Program held over a 12-week period 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Participants attending Cocinar Para Su Salud Program held over a 12-week period 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. |
|
|
| Secondary | Change in Daily Servings of Fruits and Vegetables | The change in participants intake and fruits and vegetables at 12 months (compared to baseline) as determined by diet recalls collected by an interviewer administered questionnaire. | Data on daily servings of fruits and vegetables were collected from 29 participants from each arm. | Posted | Mean | Standard Deviation | daily servings of fruits and vegetables | Baseline and 12 months |
|
|
|
| Secondary | Change in Molecular Biomarkers Associated With Breast Cancer Risk | Fasting blood will be collected at baseline and 12 months to determine whether the change in diet changes participants' biomarkers. Specifically, the change in DNA methylation (a chemical reaction in the body in which a small molecule called a methyl group gets added to DNA) will be measured against the increase in dietary factors. | Blood samples for DNA methylation were collected for 24 and 23 participants in Arm A and B respectively resulting in 24 (Arm A) and 23 (Arm B) analyzed. | Posted | Mean | Standard Deviation | percentage change in DNA methylation | Baseline and 12 months |
|
|
|
| Secondary | Change in Weight | The change in weight from baseline to 12 months. | Data on weight were collected from 29 participants from each arm. | Posted | Mean | Standard Error | kg | Baseline and 12 months |
|
|
|
| Secondary | Change in Body Mass Index (BMI) | The change in BMI from baseline to 12 months. | Data on BMI were collected from 29 participants from each arm. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline and 12 months |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Arm B (Cocinar Para Su Salud Program) | Participants attending Cocinar Para Su Salud Program held over a 12-week period 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. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D017437 |
| Skin and Connective Tissue Diseases |