NCT05488145

Terminated

Not Applicable

A Feasibility Trial of a Web Based App Intervention in Hormone Positive Breast Cancer Patients to Improve Adherence to Endocrine Therapy

Emory University8 sites in 1 country21 target enrollmentMarch 21, 2023

ConditionsAnatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 HER2-Negative Breast Carcinoma Hormone Receptor-Positive Breast Carcinoma

InterventionsBest Practice Internet-Based Intervention Questionnaire Administration Survey Administration

Overview

Phase: Not Applicable
Intervention: Best Practice
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Sponsor: Emory University
Enrollment: 21
Locations: 8
Primary Endpoint: Feasibility (Acceptability)
Status: Terminated
Last Updated: 15 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical trial looks at the use of an internet-based application (app) intervention in improving adherence to endocrine therapy (ET) among patients with early stage hormone receptor-positive HER2-negative breast cancer. ET can significantly reduce the return of the cancer in patients who are compliant with their treatment regimen. Despite this, adherence to ET is poor due to side effects, lack of social support and timely access to clinicians, and poor patient understanding of the necessity and effectiveness of the therapy. An internet-based app may help patients improve their adherence to ET by providing reminders, side effect mitigation strategies available in the educational videos and from contacting providers/ nurse on the research team directly via the app.

Detailed Description

PRIMARY OBJECTIVE: I. To assess the feasibility of a web-based app as an intervention to carry out functions such as weekly reminders, improving patient provider communication, improving patient education SECONDARY OBJECTIVES: I. To evaluate if high level of adherence to endocrine therapy can be maintained by using our web-based app in early-stage hormone positive breast cancer II. To assess whether the web-based app will improve patient satisfaction, whether patients feel the app helped improve their likelihood of adhering to endocrine therapy by making them feel more confident in their side effect management. OUTLINE: This is a single arm, feasibility study. 30 patients will be enrolled. In addition to standard of care, patients will receive access to the web-based application for the study duration (3 months). The app will have the following features: weekly text reminders to continue ET and prompts to report medication side effects, access to educational content explaining common side effects and symptom management strategies, prompts to patients to review this information when they report side effects, and most importantly, the patient will have access to their breast oncology providers to discuss their side effects and ask questions via the app. A feature unique to our app is the educational content readily available to patients. When a patient reports a side effect, the app will direct them to the relevant video explaining that side effect and going over strategies to mitigate them.

Registry

clinicaltrials.gov

Start Date

March 21, 2023

End Date

December 10, 2025

Last Updated

15 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Emory University

Responsible Party

Principal Investigator

Jane Meisel

Principal Investigator

Emory University

Eligibility Criteria

Inclusion Criteria

•Early-stage hormone receptor positive, HER2-negative breast cancer who have completed all recommended (neo)adjuvant chemotherapy, surgery and/or radiation therapy
•Age \>= 18
•Started on an aromatase inhibitor or Tamoxifen within less than or equal to six months prior to time of enrollment
•Access to internet from a desktop or a smartphone
•Ability to speak English

Exclusion Criteria

•Patients who are her2 neu positive

Arms & Interventions

Single Arm (internet intervention, best practice)

Patients receive access to the app in addition to standard of care for 3 months. Through the app, patients receive weekly reminders about hormone therapy, report any side effects, access educational videos that provide tips to help mitigate some of these side effects, and allow patients to send messages to members of our breast cancer team about any questions patients may have about the side effects they may be experiencing.

Intervention: Best Practice

Single Arm (internet intervention, best practice)

Intervention: Internet-Based Intervention

Single Arm (internet intervention, best practice)

Intervention: Questionnaire Administration

Single Arm (internet intervention, best practice)

Intervention: Survey Administration

Outcomes

Primary Outcomes

Feasibility (Acceptability)

Time Frame: Up to 1 year

Feasibility of the web-based app study will encompass: Acceptability which will be measured by using the System Usability Scale and a score if \>68 will indicate that the app was acceptable to patients. Acceptability will be summarized using descriptive statistics and confidence intervals will be reported using the Clopper-Pearson method.

Feasibility (Compliance)

Time Frame: Up to 1 year

Feasibility of the web-based app study will encompass: Compliance, which is defined as at least 5 responses from patients (via app) over the 12-week period. Compliance will be summarized using descriptive statistics, and confidence intervals will be reported using the Clopper-Pearson method. The goal is to have at least 75% of patients adhere to the app to prove compliance.