Treatment AdherenceNCT07706127
mHealth to Improve Medication Adherence Among Latina Breast Cancer Patients Experiencing Non-Medical Drivers of Health
A study testing HT Helper app use plus patient navigation support and Patient Navigation support alone in people with Treatment Adherence, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Treatment Adherence
- What is being tested?
- HT Helper app use plus patient navigation support and Patient Navigation support alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2025to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English- or Spanish-speaking Latina patients aged 18 and older who:
- 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.
Who cannot join
- Not meeting the criteria above, or patients who:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Patricia Chalela, DrPH, 210-562-6513, chalela@uthscsa.edu
About this study
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.
Read more
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
- Being tested
- HT Helper app use plus patient navigation support, Patient Navigation support alone, Usual Care
- Keywords
- phone app, breast cancer hormone therapy, treatment adherence, Latinas, non-medical drivers of health, patient navigation
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HT Helper app use plus patient navigation supportBehavioural
HT Helper app plus patient navigation support to promote hormone therapy adherence among breast cancer patients experiencing NMDoH barriers
Patient Navigation support aloneBehavioural
Patient navigation support to address NMDoH barriers impacting hormone therapy adherence
Usual CareOther
Usual care provided to patients who are prescribed hormone therapy and attend the Breast Clinic at the Mays Cancer Center
| Study group | Role | What they receive |
|---|---|---|
| Group 1: HT Helper App + Patient Navigation | Experimental | Not described Receives: Behavioral: HT Helper app use plus patient navigation support; Other: Usual Care |
| Group 2: Patient Navigation Alone | Experimental | Not described Receives: Behavioral: Patient Navigation support alone; Other: Usual Care |
| Group 3: Usual Care | Other | Control group Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to hormone therapy
Adherence to HT, defined as the percentage of doses taken as prescribed, with optimal adherence considered at ≥80%.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the intervention at 18 months
Secondary outcomes (4)
Hormone therapy medication side effects
HT side effects will be assessed with the validated BCPT Symptoms Scale, which includes 25 of the most common cancer treatment symptoms, with response options using a 5-item Likert scale ranging from 0=not at all to 4=extremely. Total scores range from 0-72 with a higher score indicating more side effects experienced
Measured: From enrollment to the end of the intervention at 18 months
Quality of life questionnaire
Quality of life (QoL) will be measured by the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. This questionnaire is well validated and has been used in multiple studies around the world.The FACT-G Version 4 is a 27-item, 5-point Likert scale questionnaire (0=Not at all to 4=Very much) measuring cancer patient quality of life, scoring between 0 and 108, where higher scores indicate better QoL. It is scored by reversing negatively phrased items, summing 4 subscales (Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being), and requires >80% completion.
Measured: From enrollment to the end of the intervention at 18 months
Depression
Depression will be assessed by the Patient Health Questionnaire (PHQ-8), an 8-item self-administered screening tool that has been validated in large clinical and population studies. Items are scored from 0=Not at all to 3=Nearly every day. Total scores range from 0-24 with a higher score indicating a higher degree of depression
Measured: From enrollment to the end of the intervention at 18 months
Anxiety
Anxiety will be assessed by the G 7-item scale (GAD-7), a validated tool used in clinical practice and research studies to assess the severity of anxiety. Each item is scored from 0=Not at all sure to 3=Nearly every day. Total scores range from 0-21 with a higher score indicating more anxiety.
Measured: From enrollment to the end of the intervention at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start26 Sep 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment AdherenceStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Chalela, DrPH, MPH, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706127
- Sponsor's protocol ID
- 20230626HU
- Other IDs
- CHERC-MSI-22-182-01
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth to Improve Medication Adherence Among Latina Breast Cancer Patients Experiencing Non-Medical Drivers of Health
- ClinicalTrials.gov ID
- NCT07706127
- Acronym / sponsor ID
- 20230626HU
- Conditions
- Treatment Adherence
- Keywords
- phone app, breast cancer hormone therapy, treatment adherence, Latinas, non-medical drivers of health, patient navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Usual CareControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HT Helper app use plus patient navigation supportHT Helper app plus patient navigation support to promote hormone therapy adherence among breast cancer patients experiencing NMDoH barriers | Behavioural | Group 1: HT Helper App + Patient Navigation |
| Patient Navigation support alonePatient navigation support to address NMDoH barriers impacting hormone therapy adherence | Behavioural | Group 2: Patient Navigation Alone |
| Usual CareUsual care provided to patients who are prescribed hormone therapy and attend the Breast Clinic at the Mays Cancer Center | Other | Group 1: HT Helper App + Patient Navigation, Group 2: Patient Navigation Alone, Group 3: Usual Care |
Primary outcome
Adherence to hormone therapy
Time frame: From enrollment to end of the intervention at 18 months
Adherence to HT, defined as the percentage of doses taken as prescribed, with optimal adherence considered at ≥80%.
Self-efficacy for Appropriate Medication Use Scale (SEAMS)
Time frame: From enrollment to the end of the intervention at 18 months
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.
Social support
Time frame: From enrollment to the end of the intervention at 18 months
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.
4 secondary outcomes
Hormone therapy medication side effects
Time frame: From enrollment to the end of the intervention at 18 months
Quality of life questionnaire
Time frame: From enrollment to the end of the intervention at 18 months
Depression
Time frame: From enrollment to the end of the intervention at 18 months
Anxiety
Time frame: From enrollment to the end of the intervention at 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patricia Chalela, DrPH, MPH principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HT Helper app use plus patient navigation support and Patient Navigation support alone in people with Treatment Adherence, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (210-567-6523, HTHelper@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to hormone therapy (time frame: From enrollment to end of the intervention at 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.