Utility of a Mobile Application for Young Women With Breast Cancer

NCT ID: NCT07009093

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2030-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Cancer Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Access to the Mighty Pro Application

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

Group Type EXPERIMENTAL

Mighty Pro Application

Intervention Type OTHER

Access to Mighty Pro Application

No Access to the Mighty Pro Application

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mighty Pro Application

Access to Mighty Pro Application

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Atrium Health Levine Cancer Institute

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lejla Hadzikadic-Gusic, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Atrium Health Levine Cancer

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Maggie Dzhanumova

Role: CONTACT

704-754-3768

Facility Contacts

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Maggie Dzhanumova

Role: primary

704-754-3768

Other Identifiers

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ONC-BRST-2401

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00119070

Identifier Type: -

Identifier Source: org_study_id

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