RecruitingNot ApplicableNCT05488145

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

Sponsor

Emory University

Enrollment

30 participants

Start Date

Mar 21, 2023

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a web-based app to help breast cancer patients take their hormone therapy pills as prescribed. Many patients stop taking these pills early, which can increase the risk of cancer coming back, so researchers want to see if an app can help with reminders and support. **You may be eligible if...** - You have early-stage, hormone receptor-positive, HER2-negative breast cancer - You have completed chemotherapy, surgery, and/or radiation therapy - You started an aromatase inhibitor or Tamoxifen within the past 6 months - You are 18 or older and able to speak English - You have access to the internet on a computer or smartphone **You may NOT be eligible if...** - Your breast cancer is HER2-positive Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBest Practice

Receive standard of care

OTHERInternet-Based Intervention

Receive application intervention

OTHERQuestionnaire Administration

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.

OTHERSurvey Administration

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.

Locations(4)

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Emory Johns Creek Hospital

Johns Creek, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT05488145

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