Clinical trial · Interventional
A Research Study for Latina Women With Breast Cancer
An e-Health Intervention to Improve Symptom Burden and Health-Related Quality of Life Among Hispanic Women Completing Active Treatment for Breast Cancer
- 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 purpose of this study is to examine the feasibility and preliminary efficacy of a psychosocial eHealth intervention designed to improve hormone therapy adherence among Hispanic/Latinx women with breast cancer. Our proposed secondary outcomes are health-related quality of life and self-efficacy in managing hormone therapy side effects. The intervention components include breast cancer knowledge, hormone/endocrine therapy knowledge, stress awareness and management, social support, and enhanced communication and intimacy skills. The intervention will be delivered via a Smartphone application over a 12-week period. All participants will receive the intervention application (described below). Aside from using the Smartphone application for the recommended 12 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), 6-week follow-up, and 12-week follow-up.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adherence, Medication | — | UNRESOLVED | — |
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer-related Problem/Condition | — | UNRESOLVED | — |
| Hormone Dependent Neoplasms | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "My Guide" (psychoeducation & self-management program) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- "My Guide" (psychoeducation & self management program)
- description
- Smartphone-based program plus standard clinical care.
- interventionNames
- Behavioral: "My Guide" (psychoeducation & self-management program)
Primary outcomes (10)
- measure
- Acceptability of My Guide: Usefulness
- timeFrame
- T3 (immediately following 12 week intervention)
- description
- To assess acceptability, all participants are asked to complete an exit interview on My Guide. This interview assesses usefulness, satisfaction, learnability and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above average scores on the questionnaire are considered acceptable. The questionnaire is administered over the phone immediately following the 12 week intervention.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Diagnosis of breast cancer, non-metastatic, stage 0-III (A, B, or C) * Receiving or received endocrine/hormone therapy within the last 3 years (36 months) * At least 18 years of age * Able to speak and read English or Spanish * Able to provide informed consent * Self-identify Hispanic/Latina ethnicity Exclusion Criteria: * Stage IV or metastatic * Visual, hearing, voice, or motor impairment that would prevent completion of study procedures * Diagnosis of an unmanaged psychotic disorder, bipolar disorder, dissociative disorder, or other diagnoses for which participation in this trial is either inappropriate or dangerous - this includes patients who have a life-threatening illness (e.g., end-stage kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment (e.g., fibromyalgia) * Illicit substance or alcohol dependence * Suicidal ideation, plan, intent * Alzheimer's, dementia, or history of stroke * Scheduled reconstruction surgery within 1 month of any study procedures or involvement.
References
Publications (0)
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