Actively Recruiting
Utility of a Mobile Application for Young Women With Breast Cancer
Led by Wake Forest University Health Sciences · Updated on 2026-03-25
120
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
A
Atrium Health Levine Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of mobile technology as a communication tool specifically for young women with breast cancer. This study focuses on measuring its effect on patient-reported cancer-related distress, addressing the unique challenges faced by this group. The research aims to assess the feasibility and effectiveness of a mobile application in reducing distress among women aged 18 to 45 years with breast cancer who have a certain level of distress. The study is a prospective, randomized trial with two stages. Participants will either receive access to the Mighty Pro Application, which offers social connectivity and educational resources, for 12 months or will not have access to this application. The study is conducted at a comprehensive cancer center and includes adult female patients who meet specific criteria regarding age, breast cancer diagnosis, and distress levels. Participants will be involved in the study for a total of 52 weeks, with evaluations at 26 weeks for feasibility and efficacy, and follow-up at 52 weeks to measure improvements in distress scores quantitatively. Assessments include patient-reported distress via the National Comprehensive Cancer Network Distress Thermometer and monitoring of app usage. The study monitors how well participants adhere to using the app and their distress outcomes over time, with no blinding or masking involved.
CONDITIONS
Brief Title
Utility of a Mobile Application for Young Women With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willingness to sign an IRB-approved informed consent
- Age 6 18 and 45 years at the time of consent
- Female
- Established patient at Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC)
- Histological confirmation of any type and stage (0-IV) of breast cancer
- Screening (baseline) NCCN Distress Thermometer score 6 4
- Access to a mobile device for trial purposes and an active email address
- Ability to read and understand the English language. NOTE: The Mighty Pro Application is available in English only.
- As determined by the enrolling Investigator, ability of the participant to understand and comply with study procedures for the entire length of the study
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants are given access to the Mighty Pro Application to support social connectivity and education aimed at reducing cancer-related distress.
Visits may occur periodically during the 12 months to assess progress
Duration - Up to 52 weeks after treatment
Participants are monitored for continued efficacy of the Mighty Pro Application in improving distress scores up to one year.
Periodic visits for assessment after treatment ends
Trial Site Locations
Total: 1 location
1
Atrium Health Levine Cancer
Charlotte, North Carolina, United States, 28204
Actively Recruiting
Research Team
M
Maggie Dzhanumova
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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