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OpenTrials
Completed

NCT Number: NCT02850939

Improving Adherence to EHT 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mays Cancer Center - MCC

San Antonio, Texas, 78229, United States

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Change in Adherence to EHT

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

    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.

Secondary outcomes

  1. Change in Quality of Life

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

    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.

  2. Change in Anxiety

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

    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.

  3. Usability and satisfaction with the mobile app

    Time frame: Outcome will be measured at 6 months

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

Improving Adherence to Endocrine Hormonal Therapy Among Breast Cancer Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2016
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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