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Improving Adherence to EHT Among Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02850939
Recruitment Status : Active, not recruiting
First Posted : August 1, 2016
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE July 20, 2016
First Posted Date  ICMJE August 1, 2016
Last Update Posted Date April 28, 2022
Actual Study Start Date  ICMJE May 3, 2021
Actual Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 27, 2016)
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 collected via the mobile app and a patient self-report short questionnaire (the MMAS-8). This scale has shown to have concurrent and predictive validity of medication adherence.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2016)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Adherence to EHT Among Breast Cancer Patients
Official Title  ICMJE Improving Adherence to Endocrine Hormonal Therapy Among Breast Cancer Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Mobile phone app + patient navigation
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 26, 2022)
108
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2016)
120
Estimated Study Completion Date  ICMJE June 2025
Actual Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02850939
Other Study ID Numbers  ICMJE HSC20160245H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data won't be shared as per protocol. Results will be presented in aggregated form without any identifiers.
Current Responsible Party The University of Texas Health Science Center at San Antonio
Original Responsible Party Amelie Ramirez, The University of Texas Health Science Center at San Antonio, Professor
Current Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amelie G. Ramirez, DrPH The University of Texas Health Science Center at San Antonio
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP