NCT07706127 mHealth to Improve Medication Adherence Among Latina Breast Cancer Patients Experiencing Non-Medical Drivers of Health
| NCT ID | NCT07706127 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Treatment Adherence |
| Study Type | INTERVENTIONAL |
| Enrollment | 159 participants |
| Start Date | 2025-09-26 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 159 participants in total. It began in 2025-09-26 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Hormonal therapy (HT) is highly effective for nearly all breast cancer patients with hormone receptor-positive tumors, which are about 80% of all breast cancer diagnoses. Long-term use of HT reduces cancer recurrence rates and cuts the risk of mortality nearly in half during the second decade after diagnosis. Despite proven benefits, 33% of women who are prescribed HT do not take it as prescribed (\<80% take their daily dosage). Latina patients are disproportionately affected by non-medical drivers of health (NMDoH) that keep them from adhering to HT and are at higher risk of breast cancer recurrence and mortality. Objective: The goal of this 4-year randomized controlled study is to assess the effectiveness of the bilingual, culturally tailored, interactive HT Helper App, in combination with patient navigation (PN), on improving adherence to HT among Latina breast cancer patients experiencing any NMDoH barriers, such as income, health insurance, education, health literacy, and language, that impact their medication adherence. This theory-based intervention will increase patient education, enhance self-efficacy, facilitate communication with the medical team and coordination of resources to address NMDoH barriers, and help patients develop self-care skills for optimal adherence to HT, ensuring patients the most equitable treatment outcomes possible, including improvement in quality of life, survival, and life expectancy. Specific Aims/Hypothesis: 1) Conduct a 3-group randomized study to assess the effectiveness of the HT Helper App + PN vs. PN alone vs. usual care, on HT adherence; and 2) Assess the effect of each study condition on patient self-efficacy to identify side effects, use self-care to manage side effects, and communicate with the medical team. We hypothesize that the HT Helper App + PN and the PN alone groups will have greater rates of HT adherence and higher patient self-efficacy than the usual care group; with the HT Helper App + PN achieving better results than both PN alone and the usual care groups. Study Design. The proposed study involves a parallel 3-group randomized controlled trial with 5-time assessments (baseline, 3, 6, 12, and 18 months) and will enroll 159 breast cancer patients who are prescribed HT and are attending the breast clinic at the Mays Cancer Center at UT Health San Antonio. Intervention components are based on Social Cognitive Theory and elements of Motivational Interviewing. Cancer Relevance. This innovative multi-level intervention will improve adherence to HT by addressing NMDoH and promote equitable breast cancer outcomes, including reduced recurrence and improved quality of life, overall survival, and life expectancy among underserved Latina patients. The anticipated outcome is a scalable, evidence-based, and easily disseminated intervention with potentially broad use to patients using oral anticancer medications.
Eligibility Criteria
Inclusion Criteria: English- or Spanish-speaking Latina patients aged 18 and older who: a) are diagnosed with hormone receptor-positive breast cancer and prescribed HT; b) within 1 to 24 months of starting HT; c) are experiencing any NMDoH by the Avanzando Center NMDoH Screener; d) are able to read; e) own a smartphone and are able to send and receive text messages and access the Internet; and f) are able to provide informed consent to participate in the study. Exclusion Criteria: Not meeting the criteria above, or patients who: a) are not Latina and are younger than 18 years; b) are not receiving HT treatment; c) with more than 24 months of starting treatment; d) do not experience any NMDoH by the Avanzando Center NMDoH Screener; e) are unable to read; f) do not own a smartphone and are unable to send and receive text messages and access the Internet; g) are unable to respond to text messages and questions or unable to download the study app; h) are unable to provide informed consent due to a mental, emotional, or physical handicap that keeps them from understanding the consent information; i) are unable to see the app and study materials and videos (i.e., are blind, deaf); and j) currently participating in a psychosocial intervention trial or individual/group psychotherapy.
Contact & Investigator
Patricia Chalela, DrPH, MPH
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT07706127 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Treatment Adherence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07706127 currently recruiting?
Yes, NCT07706127 is actively recruiting participants. Contact the research team at HTHelper@uthscsa.edu for enrollment information.
Where is the NCT07706127 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT07706127 clinical trial?
NCT07706127 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Patricia Chalela, DrPH, MPH at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 159 participants.