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NCT Number: NCT07009093

Utility of a Mobile Application for Young Women With Breast Cancer

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.

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer Distress Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Levine Cancer

Charlotte, North Carolina, 28204, United States

Location status: Recruiting

Location contact

Julie Fisher, MD

PRINCIPAL_INVESTIGATOR

Maggie Dzhanumova

CONTACT

[email protected]

704-754-3768

About this study

This is a prospective, randomized, two stage study. The target population is adult females ≥ 18 and ≤ 45 years of age with breast cancer with a National Comprehensive Cancer Network (NCCN) Distress Thermometer score of distress score ≥ 4. The study will be conducted at Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC). The hypothesis is that the social connectivity via the Mighty Pro Application, as well as the educational components available in the application, will decrease patients' cancer-related distress. This study aims to evaluate the feasibility of implementing the Mighty Pro Application and measure its efficacy at reducing distress among young women with breast cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mighty Pro Application

Other

Access to Mighty Pro Application

Primary outcomes

  1. Stage 1: Feasibility of Implementation of Mighty Pro App

    Time frame: 26 Weeks

    Binary variable indicating if at least one encounter with the application occurred for at least 80% of the weeks during the observation period. At the Participant level, the scale is either 0 (less than 80% utilization of the Mighty Pro App at least once per week during the 26-week observation period) or 1 (80% or greater utilization of the Mighty Pro App App at least once per week during the the 26-week observation period).

  2. Stage 2: Efficacy of the Mighty Pro App

    Time frame: 26 Weeks

    Binary variable indicating if at least a 2-point improvement was achieved from baseline to 26 weeks. At the Participant level, the scale is either 0 (the study participant did not achieve at least a 2-point improvement from baseline to 26 weeks on the distress scale) or 1 (the study participant did achieve at least a 2-point improvement from baseline to 26 weeks on the distress scale). The distress scale ranges from 0 (no distress) to 10 (extreme distress).

Secondary outcomes

  1. Efficacy of the Mighty Pro App in Improving Distress Scores

    Time frame: 52 Weeks

    Binary variable indicating if at least a 2-point improvement was achieved from baseline to 52 weeks. At the Participant level, the scale is either 0 (the study participant did not achieve at least a 2-point improvement from baseline to 52 weeks on the distress scale) or 1 (the study participant did achieve at least a 2-point improvement from baseline to 52 weeks on the distress scale). The distress scale ranges from 0 (no distress) to 10 (extreme distress).

  2. Efficacy of the Mighty Pro App in Improving Distress Scores - Quantitative

    Time frame: 52 Weeks

    Quantitative distress scores collected for each participant and for each time point. For each Participant and each time point a quantitative measure will be collected ranging from 0 (no distress) to 10 (extreme distress).

Study contacts

Contact information is provided by the study sponsor or research team.

Maggie Dzhanumova

CONTACT

[email protected]

704-754-3768

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Atrium Health Levine Cancer Institute

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Jun 6, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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