Breast CancerNCT07009093
Utility of a Mobile Application for Young Women With Breast Cancer
A study testing Mighty Pro Application in people with Breast Cancer and Cancer Distress, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Cancer, Cancer Distress
- What is being tested?
- Mighty Pro Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atrium Health Levine Cancer
Charlotte, North Carolina, 28204
Maggie Dzhanumova, 704-754-3768, margarita.dzhanumova@advocatehealth.org
Julie Fisher, MD
About this study
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.
Read the detailed description
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
- Breast Cancer, Cancer Distress
- Being tested
- Mighty Pro Application
- Keywords
- Cancer-related Distress, Breast Cancer, Young Adult Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mighty Pro ApplicationOther
Access to Mighty Pro Application
| Study group | Role | What they receive |
|---|---|---|
| Access to the Mighty Pro Application | Experimental | Participants will be given access to the Mighty Pro Application for 12 months. Receives: Other: Mighty Pro Application |
| No Access to the Mighty Pro Application | No intervention | Participants will not be given access to the Mighty Pro Application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 26 Weeks
Secondary outcomes (2)
Efficacy of the Mighty Pro App in Improving Distress Scores
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).
Measured: 52 Weeks
Efficacy of the Mighty Pro App in Improving Distress Scores - Quantitative
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).
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study startSep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Julie Fisher, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009093
- Sponsor's protocol ID
- IRB00119070
- Other IDs
- ONC-BRST-2401
- Status last verified
- Jul 2026
- First submitted
- 28 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of a Mobile Application for Young Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT07009093
- Acronym / sponsor ID
- IRB00119070
- Conditions
- Breast Cancer, Cancer Distress
- Keywords
- Cancer-related Distress, Breast Cancer, Young Adult Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Access to the Mighty Pro Application | Experimental | Other: Mighty Pro ApplicationParticipants will be given access to the Mighty Pro Application for 12 months. |
| No Access to the Mighty Pro Application | No intervention | –Participants will not be given access to the Mighty Pro Application. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mighty Pro ApplicationAccess to Mighty Pro Application | Other | Access to the Mighty Pro Application |
Primary outcome
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).
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).
2 secondary outcomes
Efficacy of the Mighty Pro App in Improving Distress Scores
Time frame: 52 Weeks
Efficacy of the Mighty Pro App in Improving Distress Scores - Quantitative
Time frame: 52 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Fisher, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mighty Pro Application in people with Breast Cancer and Cancer Distress, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maggie Dzhanumova (704-754-3768, margarita.dzhanumova@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage 1: Feasibility of Implementation of Mighty Pro App (time frame: 26 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.