Clinical trial · Interventional
A Research Study for Latina Women Undergoing Breast Cancer Treatment
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 effects of a developed psychosocial eHealth intervention on the proposed primary outcomes, health-related quality of life and symptom burden, among Hispanic breast cancer patients. The intervention components include breast cancer 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. Participants are randomized into either an intervention application (described below) or standard treatment. 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 (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Problem/Condition | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Stress, Emotional | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| My Guide | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- "My Guide" (psychoeducation & self-management program)
- description
- Smartphone-based program plus standard clinical care.
- interventionNames
- Behavioral: My Guide
- type
- NO_INTERVENTION
- label
- Standard Medical Care
- description
- Standard clinical care with no smartphone intervention.
Primary outcomes (2)
- measure
- Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy-Breast (FACT-B)
- timeFrame
- HRQoL will be first assessed at baseline (T1), initial HRQoL changes will be assessed at 6 weeks post-baseline (T2), and finally any additional HRQoL changes will be captured 12 weeks post-baseline (T3)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Diagnosis of breast cancer, non-metastatic, stage 0-IIIA; for women diagnosed with stage 0, either radiation or chemotherapy is required as an additional treatment to surgery * Currently undergoing cancer treatment \[e.g., surgery, chemotherapy, radiation, or combination of the two or three\] * at least 21 years of age * Able to speak and read English or Spanish * Able to provide informed consent * Elevated score on breast cancer symptom burden and HRQoL, measured by the Functional Assessment of Cancer Therapy-Breast questionnaire using an established cut-off score for clinically meaningful, compromised HRQoL * Self-identified Hispanic/Latina ethnicity. Exclusion Criteria: * 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 diagnosis for which participation in this trial is either inappropriate or dangerous - this includes patients who have 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)
Data not yet available