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

Inclusion Criteria5

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 Criteria1

Patients who are her2 neu positive

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.