Clinical trial · Interventional
Cook for Your Life!: Implementing Dietary Change Among Hispanic Breast Cancer Survivors
Cocinar Para su Salud! (Cook for Your Life!): Implementing Dietary Change Among Hispanic Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cocinar Para Su Salud Program | Behavioral | — | UNRESOLVED |
| Written dietary recommendations | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Participants receiving written dietary recommendations for breast cancer survivors (control arm)
- interventionNames
- Behavioral: Written dietary recommendations
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Participants attending Cocinar Para Su Salud Program held over a 12-week period
- interventionNames
- Behavioral: Cocinar Para Su Salud Program
Primary outcomes (1)
- measure
- Change in Daily Servings of Fruits and Vegetables
- timeFrame
- Baseline and 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDHooper 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. PMID 32476140
- DERIVEDShi 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. PMID 29904989