N/A
N=70
Cook for Your Life!: Implementing Dietary Change Among Hispanic Breast Cancer Survivors
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01414062 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Change in Daily Servings of Fruits and Vegetables — -0.1; 2.0 daily servings of fruits and vegetables
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cocinar Para Su Salud Program (Behavioral); Written dietary recommendations (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Daily Servings of Fruits and Vegetables |
-0.2; 1.6 | — |
| SECONDARY Change in Daily Servings of Fruits and Vegetables |
-0.2; 1.6 | — |
| SECONDARY Change in Molecular Biomarkers Associated With Breast Cancer Risk |
-0.7; 1.2 | — |
| SECONDARY Change in Weight |
2.3; -2.2 | — |
| SECONDARY Change in Body Mass Index (BMI) |
-0.6; -1.0 | — |
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.
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 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 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.
Data sourced from ClinicalTrials.gov (NCT01414062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.