Clinical trial · Interventional
Diet and Physical Activity Changes Among Latina Breast Cancer Survivors
Mi Vida Saludable: Maintaining Diet and Physical Activity Changes Among Latina 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 investigators will conduct a 2x2 factorial randomized controlled trial to test the separate and synergistic effects of an in-person hands-on dietary and physical activity change curriculum (i.e., Mi Vida Saludable program) and e-communication strategies (text messaging, emailed newsletters and an interactive website) on changing dietary and physical activity behaviors among a diverse population of Latina breast cancer survivors who have completed breast cancer treatment. Participants will be evenly randomized to 4 arms: in-person education alone, e-communication alone, in-person education plus e-communication, or control.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Behavioral | — | UNRESOLVED |
| E-communication | Behavioral | — | UNRESOLVED |
| In-person education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Subjects will receive in-person education plus e-communication AND subjects will receive control intervention
- interventionNames
- Behavioral: In-person education
- Behavioral: E-communication
- Behavioral: Control
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Subjects will receive e-communication alone AND subjects will receive control intervention
- interventionNames
- Behavioral: E-communication
- Behavioral: Control
- type
- EXPERIMENTAL
- label
- Arm C
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female. 2. 21 years of age or older. 3. Self-identify as Hispanic/Latina. 4. Speak Spanish or English. Disease Related Criteria 5. Medical history of histologically confirmed stage 0, I, II, III breast cancer, with no evidence of metastatic disease. Prior/ Current Therapy Criteria 6. At least 90 days post chemotherapy, biologic therapy, or radiation therapy treatment and/or breast surgery. Current use of hormonal therapy is permitted (e.g., tamoxifen and aromatase inhibitors). Accessibility Criteria 7. Have access to computer or smartphone. Clinical/ Laboratory Criteria 8. No history of smoking within the past 30 days. 9. No uncontrolled diabetes mellitus defined as Hgb A1C \>7% 10. Consume \<5 servings of fruits and vegetables per day and/or engages in \<150 weekly minutes of moderate to vigorous physical activity. Exclusion Criteria: Any criterion not met under inclusion.
References
Publications (2)
- DERIVEDMarin-Chollom AM, Hale C, Koch P, Gaffney AO, Contento I, Shen H, Hershman DL, Brickman AM, Greenlee H. Cognitive Functioning and Health in Hispanic/Latina Breast Cancer Survivors. J Immigr Minor Health. 2022 Jun;24(3):597-604. doi: 10.1007/s10903-021-01300-w. Epub 2021 Oct 28. PMID 34709529
- DERIVEDSantiago-Torres M, Contento I, Koch P, Tsai WY, Brickman AM, Gaffney AO, Thomson CA, Crane TE, Dominguez N, Sepulveda J, Marin-Chollom AM, Paul R, Shi Z, Ulanday KT, Hale C, Hershman D, Greenlee H. inverted exclamation markMi Vida Saludable! A randomized, controlled, 2 x 2 factorial trial of a diet and physical activity intervention among Latina breast cancer survivors: Study design and methods. Contemp Clin Trials. 2021 Nov;110:106524. doi: 10.1016/j.cct.2021.106524. Epub 2021 Aug 6. PMID 34365016