A Feasibility Trial of a Web Based App Intervention in Hormone Positive Breast Cancer Patients to Improve Adherence to Endocrine Therapy
NCT ID: NCT05488145
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2023-03-21
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single Arm (internet intervention, best practice)
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.
Best Practice
Receive standard of care
Internet-Based Intervention
Receive application intervention
Questionnaire 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.
Survey 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Best Practice
Receive standard of care
Internet-Based Intervention
Receive application intervention
Questionnaire 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.
Survey 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jane Meisel
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jane L. Meisel, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ashley Lynn Trumbull
Role: primary
Ashley Lynn Trumbull
Role: primary
Ashley Lynn Trumbull
Role: primary
Ashley Lynn Trumbull
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2022-03205
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00004350
Identifier Type: OTHER
Identifier Source: secondary_id
WINSHIP5532-22
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00004350
Identifier Type: -
Identifier Source: org_study_id