Mobile app support for young women with breast cancer
Utility of a Mobile Application for Young Women With Breast Cancer
NA · Wake Forest University Health Sciences · NCT07009093
This project will test whether the Mighty Pro mobile app can help lower cancer-related distress in women aged 18–45 with breast cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT07009093 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, two-stage intervention conducted through Wake Forest/Atrium Health cancer centers enrolling women 18–45 with breast cancer who report significant distress (NCCN Distress Thermometer ≥4). Participants will use the Mighty Pro mobile application, which offers social connectivity and educational content, and outcomes will be compared between randomized groups. The study measures feasibility of implementing the app and its effect on patient-reported cancer-related distress using validated distress screening. Enrollment is limited to English-speaking patients with access to a mobile device and an active email address.
Who should consider this trial
Good fit: Ideal candidates are English-speaking female patients aged 18–45 with histologically confirmed breast cancer, an NCCN Distress Thermometer score of 4 or higher, access to a mobile device and email, and who are established patients at the enrolling center.
Not a fit: Patients older than 45, those with low baseline distress, those without a smartphone or email, non-English speakers, or those who prefer in-person support may not receive benefit from this mobile-app intervention.
Why it matters
Potential benefit: If successful, the app could reduce cancer-related distress and improve social support and access to information for young women with breast cancer.
How similar studies have performed: Related mobile and online psychosocial interventions for cancer patients have shown mixed but generally promising results in reducing distress, though few prior trials focus specifically on young women with breast cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to understand and willingness to sign an IRB-approved informed consent * Age ≥ 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 ≥ 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 Exclusion Criteria: \- None
Where this trial is running
Charlotte, North Carolina
- Atrium Health Levine Cancer — Charlotte, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Lejla Hadzikadic-Gusic, MD — Wake Forest University Health Sciences
- Study coordinator: Maggie Dzhanumova
- Email: margarita.dzhanumova@advocatehealth.org
- Phone: 704-754-3768
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Cancer Distress, Cancer-related Distress, Young Adult Cancer