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

NCT05488145 | Terminated

• 4 other identifiers: STUDY00004350NCI-2022-03205WINSHIP5532-22P30CA138292
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Feasibility (Acceptability)

  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.

  Up to 1 year

• Feasibility (Compliance)

  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.

  Up to 1 year

Secondary Outcomes (2)

• Adherence

  Up to 1 year

• Patient satisfaction

  Up to 1 year

Study Arms (1)

Single Arm (internet intervention, best practice)

EXPERIMENTAL

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.

Other: Best Practice; Other: Internet-Based Intervention; Other: Questionnaire Administration; Other: Survey Administration

Interventions

Best Practice OTHER

Receive standard of care

Single Arm (internet intervention, best practice)

Internet-Based Intervention OTHER

Receive application intervention

Single Arm (internet intervention, best practice)

Questionnaire Administration OTHER

PROMIS medication adherence questionnaire is a well-defined self-report measure of medication-taking habits used to objectively assess adherence to medication and therapy. At the end of the study period, we will perform data analysis.

Single Arm (internet intervention, best practice)

Survey Administration OTHER

Improvement in patient satisfaction will be measured by utilizing Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey scores. Surveys will be conducted among all participants at baseline and at 12 weeks, regardless of their use of the app, to better understand any barriers to using the app and which aspects of the app were most useful to patients.

Single Arm (internet intervention, best practice)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Patients who are her2 neu positive

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

MeSH Terms

Interventions

Practice Guidelines as Topic

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jane L. Meisel, MD

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: August 4, 2022
• Study Start: March 21, 2023
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (4)