Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07009093

Conditions

Breast Cancer

Cancer Distress

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Mighty Pro Application

Study Details

Brief summary:

This study aims to evaluate the use of mobile technology as a communication tool among patients with breast cancer and measured its effect on patient-reported cancer-related distress, specifically focusing on young women as they often face unique challenges.

Conditions

Breast Cancer

Cancer Distress

Study ID

NCT07009093

Start date

Aug, 2026

Status verified date

Jul, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Access to the Mighty Pro Application

Participants will be given access to the Mighty Pro Application for 12 months.

no intervention: No Access to the Mighty Pro Application

Participants will not be given access to the Mighty Pro Application.

Interventions

Mighty Pro Application

Access to Mighty Pro Application

Primary outcome measure

  • Stage 1: Feasibility of Implementation of Mighty Pro App [ Time Frame: 26 Weeks ]
  • Stage 2: Efficacy of the Mighty Pro App [ Time Frame: 26 Weeks ]

Central Contacts and Locations

Central contacts

Maggie Dzhanumova

704-754-3768margarita.dzhanumova@advocatehealth.org

Locations

Atrium Health Levine Cancer

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Maggie Dzhanumova

704-754-3768margarita.dzhanumova@advocatehealth.org

Principal Investigator:

Julie Fisher, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Cancer-related Distress
  • Breast Cancer
  • Young Adult Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-22.