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Mobile App for Distress Reduction in Young Women with Breast Cancer

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What is being tested

Mighty Pro Application

Other
Who is being recruted

Breast Cancer

+ Cancer Distress
From 18 to 45 Years
+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: December 2025

See protocol details

Summary

Principal SponsorWake Forest University Health Sciences
Study ContactMaggie Dzhanumova
Last updated: August 24, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2025Actual date on which the first participant was enrolled.

This clinical trial focuses on young women aged 18 to 45 who have been diagnosed with breast cancer and are experiencing significant distress, as indicated by a distress score of 4 or higher on a specific scale. The study aims to explore whether a mobile app called Mighty Pro can help reduce cancer-related stress through social connections and educational resources. This could be important because managing stress is a crucial aspect of the overall treatment and well-being of young women with breast cancer. In this study, participants use the Mighty Pro app, which is designed to provide social support and educational content. The trial is conducted at the Atrium Health Wake Forest Baptist Comprehensive Cancer Center. Researchers will monitor how effectively the app reduces distress levels in participants. The study is organized into two stages and will evaluate both the feasibility of using this app and its effectiveness in offering emotional support. The goal is to see if this digital tool can be a beneficial addition to the supportive care for young women facing breast cancer.

Official TitleUtility of a Mobile Application for Young Women With Breast Cancer 
Principal SponsorWake Forest University Health Sciences
Study ContactMaggie Dzhanumova
Last updated: August 24, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
120 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 18 to 45 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
Cancer Distress
Criteria
9 inclusion criteria required to participate
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)

Show More Criteria

1 exclusion criteria prevent from participating
None

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants will be given access to the Mighty Pro Application for 12 months.
Group II
No Intervention
Participants will not be given access to the Mighty Pro Application.
Study Objectives
Primary Objectives

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).

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 Objectives

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).

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Atrium Health Levine CancerCharlotte, United StatesSee the location
Recruiting soonOne Study Center