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

Last updated: December 6, 2024
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

Questionnaire Administration

Internet-Based Intervention

Best Practice

Clinical Study ID

NCT05488145
STUDY00004350
P30CA138292
WINSHIP5532-22
NCI-2022-03205
STUDY00004350
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Early-stage hormone receptor positive, HER2-negative breast cancer who havecompleted all recommended (neo)adjuvant chemotherapy, surgery and/or radiationtherapy

  • Age >= 18

  • Started on an aromatase inhibitor or Tamoxifen within less than or equal to sixmonths prior to time of enrollment

  • Access to internet from a desktop or a smartphone

  • Ability to speak English

Exclusion

Exclusion Criteria:

  • Patients who are her2 neu positive

Study Design

Total Participants: 30
Treatment Group(s): 4
Primary Treatment: Questionnaire Administration
Phase:
Study Start date:
March 21, 2023
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Emory Johns Creek Hospital

    Johns Creek, Georgia 30097
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.