Improving Adherence to EHT Among Breast Cancer Patients

Improving Adherence to Endocrine Hormonal Therapy Among Breast Cancer Patients

Adjuvant endocrine hormonal therapy (EHT) is highly effective and appropriate for nearly all breast cancer patients with hormone receptor-positive tumors, which represent 75% of all breast cancer diagnoses. Long-term use of EHT reduces cancer recurrence rates and cuts the risk of death nearly in half during the second decade after diagnosis, research shows. Despite the proven benefits, about 33% of women who are prescribed EHT do not take their medication as prescribed (less than 80% take their daily dosage) and are thus at higher risk of recurrence and death.

This educational randomized controlled study will develop and pilot-test a bilingual, culturally tailored, personalized, interactive mobile application (app) in combination with patient navigation to promote and improve adherence to endocrine hormonal therapy (EHT) among breast cancer patients.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Mobile phone app + patient navigation

Detailed Description

The proposed two-year study involves a 2-group randomized control trial with 3-time assessments (baseline, 3 and 6 months) and will enroll 120 breast cancer patients who are prescribed EHT and are attending the breast clinic at the Mays Cancer Center (MCC), a National Cancer Institute-designated cancer center at the University of Texas Health Science Center at San Antonio. The intervention group will receive two components: 1) a bilingual, culturally tailored, personalized, interactive mobile app; and 2) support from a patient navigator. The control group will receive the usual care and information provided by the MCC's breast clinic and pharmacy to patients undergoing oral EHT. The intervention components are based in Social Cognitive Theory and elements of Motivational Interviewing.

The proposed study aims to:

1. Develop a bilingual, culturally tailored, personalized, interactive mobile application (app) to promote and improve EHT adherence among breast cancer patients diagnosed with hormone receptor-positive breast cancer. The app will 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.
2. 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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Mays Cancer Center - MCC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English and Spanish speaking adult patients, 18 years of age and older who: a) are diagnosed with hormone receptor-positive breast cancer and prescribed endocrine hormonal treatment (EHT); b) own a cell phone, are able to send and receive text message and access the internet; and c) are able to provide informed consent to participate in the study.

Exclusion Criteria:

• Patients who: (a) are unable to provide consent due to a mental, emotional, or physical handicap, that keep them from understanding the consent information; (b) do not own a smart phone; (c) are unable to respond to text messages and questions or unable download the study app; d) are unable to see the app and study materials and videos (i.e., are blind, deaf)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile phone app + patient navigation; Patients assigned to the intervention group (60) will: 1) use the personalized mobile phone app in their preferred language for a duration of 6 months; and 2) receive assistance from a patient navigator. They will also continue to receive the usual EHT care provided at the MCC's breast clinic.	Behavioral: Mobile phone app + patient navigation; The intervention group will receive two components: 1) a culturally sensitive, personalized and easy to use smartphone app; and 2) support from a patient navigator. The intervention is based in Social Cognitive Theory and principles of motivational interviewing - and will feature basic components of individual empowerment, motivation and engagement, including knowledge, attitudes, skills, peer modeling, social support/reinforcement and self-efficacy beliefs and expectations
No Intervention: Usual care; Patients assigned to the control (usual care) group (60) will receive the usual EHT care and materials offered at the MCC's breast clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Adherence to EHT	We will review prescribing and refill records for EHT (tamoxifen or aromatase inhibitors -AIs) and the number of days cover by each prescription, the number of dispensed tablets and the daily dose, to calculate an adherence index across the 6-month intervention.18 In addition we will use monthly self-reporting data via the mobile app using 3 questions developed by the research team.	Outcome will be assessed at 3 points: baseline, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life	Quality of life 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.	Outcome will be assessed at 3 points: baseline, 3 and 6 months
Change in Anxiety	To assess anxiety we will use the Generalized Anxiety Disorder 7-item scale (GAD-7), a validated tool used in clinical practice and research studies to assess the severity of anxiety.	Outcome will be assessed at 3 points: baseline, 3 and 6 months
Usability and satisfaction with the mobile app	we will assess usability and satisfaction of the mobile app by including a small set of questions developed by the research team with response options ranging from completely agree to completely disagree.	Outcome will be measured at 6 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Amelie G. Ramirez, DrPH, The University of Texas Health Science Center at San Antonio

Publications and helpful links

General Publications

• Chalela P, Munoz E, Inupakutika D, Kaghyan S, Akopian D, Kaklamani V, Lathrop K, Ramirez A. Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2018 Oct 17;12:109-115. doi: 10.1016/j.conctc.2018.10.001. eCollection 2018 Dec. Erratum In: Contemp Clin Trials Commun. 2019 Mar 17;14:100349.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimated): August 1, 2016

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Breast cancer; mHealth; Endocrine hormonal therapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HSC20160245H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data won't be shared as per protocol. Results will be presented in aggregated form without any identifiers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No