Breast Cancer
Conditions
Keywords
Breast Cancer, Healthy meals, Cocinar, Dietary, Dietary Intervention, fruits and vegetables, Cancer survivor, Nutrition
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.
Interventions
BEHAVIORALCocinar 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.
BEHAVIORALWritten 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
Sponsors
National Cancer Institute (NCI)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Servings of Fruits and Vegetables | Baseline and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Servings of Fruits and Vegetables | Baseline and 12 months | 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. |
| Change in Molecular Biomarkers Associated With Breast Cancer Risk | Baseline and 12 months | 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. |
| Change in Weight | Baseline and 12 months | The change in weight from baseline to 12 months. |
| Change in Body Mass Index (BMI) | Baseline and 12 months | The change in BMI from baseline to 12 months. |
Countries
United States
Participant flow
Pre-assignment details
82 participants were enrolled and 12 withdrew, resulting in 70 participants being randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 36 |
| 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. | 34 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Family Disapproval | 1 | 0 |
| Overall Study | Left Country | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Arm B | Total | Arm A |
|---|---|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 9.1 | 56.6 years STANDARD_DEVIATION 9.7 | 58 years STANDARD_DEVIATION 10.1 |
| Race/Ethnicity, Customized Black | 7 Participants | 18 Participants | 11 Participants |
| Race/Ethnicity, Customized Colombian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Cuban | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Dominican | 24 Participants | 54 Participants | 30 Participants |
| Race/Ethnicity, Customized Ecuadorian | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized El Salvadorian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Honduran | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Mexican | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Missing Race | 6 Participants | 11 Participants | 5 Participants |
| Race/Ethnicity, Customized Mixed | 5 Participants | 11 Participants | 6 Participants |
| Race/Ethnicity, Customized Native American | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Other Ethnicity (not specified) | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Puerto Rican | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 14 Participants | 28 Participants | 14 Participants |
| Region of Enrollment United States | 34 Participants | 70 Participants | 36 Participants |
| Sex: Female, Male Female | 34 Participants | 70 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Control Arm) | Change in Daily Servings of Fruits and Vegetables | -0.1 daily servings of fruits and vegetables | Standard Error 0.5 |
| Arm B (Cocinar Para Su Salud Program) | Change in Daily Servings of Fruits and Vegetables | 2.0 daily servings of fruits and vegetables | Standard Error 0.5 |
Secondary
Change in Body Mass Index (BMI)
The change in BMI from baseline to 12 months.
Time frame: Baseline and 12 months
Population: Data on BMI were collected from 29 participants from each arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Control Arm) | Change in Body Mass Index (BMI) | -0.6 kg/m^2 | Standard Deviation 2.4 |
| Arm B (Cocinar Para Su Salud Program) | Change in Body Mass Index (BMI) | -1.0 kg/m^2 | Standard Deviation 3.2 |
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.
Time frame: Baseline and 12 months
Population: Data on daily servings of fruits and vegetables were collected from 29 participants from each arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Control Arm) | Change in Daily Servings of Fruits and Vegetables | -0.2 daily servings of fruits and vegetables | Standard Deviation 2.5 |
| Arm B (Cocinar Para Su Salud Program) | Change in Daily Servings of Fruits and Vegetables | 1.6 daily servings of fruits and vegetables | Standard Deviation 2.2 |
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.
Time frame: Baseline and 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Control Arm) | Change in Molecular Biomarkers Associated With Breast Cancer Risk | -0.7 percentage change in DNA methylation | Standard Deviation 3.8 |
| Arm B (Cocinar Para Su Salud Program) | Change in Molecular Biomarkers Associated With Breast Cancer Risk | 1.2 percentage change in DNA methylation | Standard Deviation 3.5 |
Secondary
Change in Weight
The change in weight from baseline to 12 months.
Time frame: Baseline and 12 months
Population: Data on weight were collected from 29 participants from each arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Control Arm) | Change in Weight | 2.3 kg | Standard Error 2.6 |
| Arm B (Cocinar Para Su Salud Program) | Change in Weight | -2.2 kg | Standard Error 2.6 |