Clinical trial NCT05488145: A Feasibility Trial of a Web Based App Intervention in Hormone Positive Breast Cancer Patients to Improve Adherence to Endocrine Therapy
Official title: A Feasibility Trial of a Web Based App Intervention in Hormone Positive Breast Cancer Patients to Improve Adherence to Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
HER2-Negative Breast Carcinoma
Hormone Receptor-Positive Breast Carcinoma
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Feasibility (Acceptability)
timeFrame: Up to 1 year
measure: Feasibility (Compliance)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Adherence
timeFrame: Up to 1 year
measure: Patient satisfaction
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: Johns Creek
country: United States
facility: Emory Johns Creek Hospital
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Jane L. Meisel, MD
role: PRINCIPAL_INVESTIGATOR
References: