NCT07009093

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
45mo left

Started Apr 2026

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Jan 2030

First Submitted

Initial submission to the registry

May 28, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

May 28, 2025

Last Update Submit

March 20, 2026

Conditions

Breast CancerCancer Distress

Keywords

Cancer-related DistressBreast CancerYoung Adult Cancer

Outcome Measures

Primary Outcomes (2)

  • Stage 1: Feasibility of Implementation of Mighty Pro App

    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).

    26 Weeks

  • Stage 2: Efficacy of the Mighty Pro App

    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).

    26 Weeks

Secondary Outcomes (2)

  • Efficacy of the Mighty Pro App in Improving Distress Scores

    52 Weeks

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

    52 Weeks

Study Arms (2)

Access to the Mighty Pro Application

EXPERIMENTAL

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

Other: Mighty Pro Application

No Access to the Mighty Pro Application

NO INTERVENTION

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

Interventions

Mighty Pro ApplicationOTHER

Access to Mighty Pro Application

Access to the Mighty Pro Application

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium Health Levine Cancer

Charlotte, North Carolina, 28204, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lejla Hadzikadic-Gusic, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maggie Dzhanumova

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 6, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2030

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)