Improving Adherence to EHT Among Breast Cancer Patients

NCT02850939 | Completed

• 1 other identifier: HSC20160245H
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Endocrine hormonal therapy; mHealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Quality of Life

  Outcome will be assessed at 3 points: baseline, 3 and 6 months

• Change in Anxiety

  Outcome will be assessed at 3 points: baseline, 3 and 6 months

• Usability and satisfaction with the mobile app

  Outcome will be measured at 6 months

Study Arms (2)

Mobile phone app + patient navigation

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Patients assigned to the control (usual care) group (60) will receive the usual EHT care and materials offered at the MCC's breast clinic.

Interventions

Mobile phone app + patient navigation 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

Mobile phone app + patient navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Mays Cancer Center - MCC

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 30377674 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Amelie G. Ramirez, DrPH

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: August 1, 2016
• Study Start: May 3, 2021
• Primary Completion: March 31, 2022
• Study Completion: September 30, 2022
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)