This randomized clinical trial studies how well a bilingual, culturally tailored, personalized, interactive mobile application works in promoting and improving endocrine hormonal therapy adherence in patients with hormone receptor positive breast cancer. The mobile application may help empower patients’ self-monitoring and management, as well as facilitate patient education, early identification and reporting of side effects, delivery of self-care advice, and timely feedback through direct interaction between the patient and the oncology team when necessary.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02850939.
PRIMARY OBJECTIVES:
I. Develop a bilingual, culturally tailored, personalized, interactive mobile application (app) to promote and improve endocrine hormonal therapy (EHT) adherence among breast cancer patients diagnosed with hormone receptor positive breast cancer.
II. Conduct a 2-group randomized controlled study to assess the feasibility and effectiveness of a bilingual, culturally tailored, personalized, interactive app + patient navigation (PN) to promote EHT adherence compared to usual care among patients diagnosed with hormone receptor-positive breast cancer and who are prescribed EHT.
OUTLINE:
FORMATIVE RESEARCH: Focus groups with breast cancer patients are conducted (2 in English and 2 Spanish) to assess the most common barriers and facilitators to treatment adherence in order to address them in the intervention. Focus groups are also conducted with breast cancer patients and key stakeholders to assess mockups, interactive features, content, usability, clarity, etc. of the mobile app. In-depth interviews are conducted with oncology physicians and nurses to provide advice regarding content of key app components. Beta testing of the mobile app is conducted with breast cancer patients to identify any potential issues prior to the start of the intervention. Medical record review is conducted to serve as baseline data to assess breast cancer patients’ adherence rates prior to the beginning of the study.
INTERVENTION: Patients are randomized to 1 of 2 groups.
GROUP I: Patients use the bilingual, culturally tailored, personalized, interactive mobile phone app in their preferred language for 6 months. Patients also receive support and assistance from a patient navigator (PN) monthly for 6 months.
GROUP II: Patients receive general print information on EHT usually provided to eligible patients at the Cancer Therapy and Research Center's (CTRC's) breast clinic.
After completion of study, patients are followed up periodically.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationCancer Therapy and Research Center at The UT Health Science Center at San Antonio
Principal InvestigatorAmelie Ramirez
