Cocinar Para su Salud! (Cook for Your Life!)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 5/21/2016 |
| Start Date: | January 2011 |
| End Date: | September 2016 |
Cocinar Para su Salud! (Cook for Your Life!): Implementing Dietary Change Among Hispanic Breast Cancer Survivors
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.
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.
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.
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.
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.
We found this trial at
1
site
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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