Trial Title:
A Feasibility Trial of a Web Based App Intervention in Hormone Positive Breast Cancer Patients to Improve Adherence to Endocrine Therapy
NCT ID:
NCT05488145
Condition:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
HER2-Negative Breast Carcinoma
Hormone Receptor-Positive Breast Carcinoma
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive standard of care
Arm group label:
Single Arm (internet intervention, best practice)
Intervention type:
Other
Intervention name:
Internet-Based Intervention
Description:
Receive application intervention
Arm group label:
Single Arm (internet intervention, best practice)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
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.
Arm group label:
Single Arm (internet intervention, best practice)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
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.
Arm group label:
Single Arm (internet intervention, best practice)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory University Hospital Midtown
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Lynn Trumbull
Phone:
404-778-3969
Email:
ashley.lynn.trumbull@emory.edu
Investigator:
Last name:
Jane L. Meisel, MD
Email:
Principal Investigator
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Lynn Trumbull
Phone:
404-778-3969
Email:
ashley.lynn.trumbull@emory.edu
Investigator:
Last name:
Jane L. Meisel, MD
Email:
Principal Investigator
Facility:
Name:
Emory Saint Joseph's Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Lynn Trumbull
Phone:
404-778-3969
Email:
ashley.lynn.trumbull@emory.edu
Investigator:
Last name:
Jane L. Meisel, MD
Email:
Principal Investigator
Facility:
Name:
Emory Johns Creek Hospital
Address:
City:
Johns Creek
Zip:
30097
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Ashley Lynn Trumbull
Phone:
404-778-3969
Email:
ashley.lynn.trumbull@emory.edu
Investigator:
Last name:
Jane L. Meisel, MD
Email:
Principal Investigator
Start date:
March 21, 2023
Completion date:
May 30, 2025
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05488145
