Improving Adherence to EHT Among Breast Cancer Patients

NCT ID: NCT02850939

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2022-09-30

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mobile phone app + patient navigation

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amelie G. Ramirez, DrPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

Mays Cancer Center - MCC

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30377674 (View on PubMed)

Other Identifiers

HSC20160245H

Identifier Type: -

Identifier Source: org_study_id