mHealth to Improve Medication Adherence Among Latina Breast Cancer Patients Experiencing Non-Medical Drivers of Health

NCT07706127 | Recruiting

• 2 other identifiers: 20230626HUCHERC-MSI-22-182-01
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Adherence

Keywords

phone app; breast cancer hormone therapy; treatment adherence; Latinas; non-medical drivers of health; patient navigation

Outcome Measures

Primary Outcomes (3)

• Adherence to hormone therapy

  Adherence to HT, defined as the percentage of doses taken as prescribed, with optimal adherence considered at ≥80%.

  From enrollment to end of the intervention at 18 months

• Self-efficacy for Appropriate Medication Use Scale (SEAMS)

  Self-efficacy for medication adherence will be measured using the Self-Efficacy for Appropriate Medication Use Scale (SEAMS), a validated 13-item instrument with three-point Likert scale response options ranging from 1=not confident to 3=very confident.Total scores range from 13-39 with a higher score indicating better confidence in self-efficacy.

  From enrollment to the end of the intervention at 18 months

• Social support

  Social support will be measured by the Multidimensional Scale of Perceived Social Support. This is a validated instrument with 12 questions rating three sources of support (family, friends, and significant others). Response options include a 7-point Likert scale ranging from 1=very strongly disagree to 7=very strongly agree. Total scores range from 12-84 with a higher score indicating stronger perceived social support.

  From enrollment to the end of the intervention at 18 months

Secondary Outcomes (4)

• Hormone therapy medication side effects

  From enrollment to the end of the intervention at 18 months

• Quality of life questionnaire

  From enrollment to the end of the intervention at 18 months

• Depression

  From enrollment to the end of the intervention at 18 months

• Anxiety

  From enrollment to the end of the intervention at 18 months

Study Arms (3)

Group 1: HT Helper App + Patient Navigation

EXPERIMENTAL

Behavioral: HT Helper app use plus patient navigation support; Other: Usual Care

Group 2: Patient Navigation Alone

EXPERIMENTAL

Behavioral: Patient Navigation support alone; Other: Usual Care

Group 3: Usual Care

OTHER

Control group

Other: Usual Care

Interventions

HT Helper app use plus patient navigation support BEHAVIORAL

HT Helper app plus patient navigation support to promote hormone therapy adherence among breast cancer patients experiencing NMDoH barriers

Group 1: HT Helper App + Patient Navigation

Patient Navigation support alone BEHAVIORAL

Patient navigation support to address NMDoH barriers impacting hormone therapy adherence

Group 2: Patient Navigation Alone

Usual Care OTHER

Usual care provided to patients who are prescribed hormone therapy and attend the Breast Clinic at the Mays Cancer Center

Group 1: HT Helper App + Patient Navigation; Group 2: Patient Navigation Alone; Group 3: Usual Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females (biological sex)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Patricia Chalela, DrPH, MPH

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

210-567-6523; HTHelper@uthscsa.edu

Research Assistant

CONTACT

210-567-6523; HTHelper@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 15, 2026
• Study Start: September 26, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

US (1)