Utility of a Mobile Application for Young Women With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mighty Pro Application.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Cancer Distress. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Mighty Pro Application
Access to Mighty Pro Application
Primary outcome measures
- Stage 1: Feasibility of Implementation of Mighty Pro App [Time frame: 26 Weeks]
- Stage 2: Efficacy of the Mighty Pro App [Time frame: 26 Weeks]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Atrium Health Levine Cancer — Charlotte
Identifiers
NCT: NCT07009093 · IRB00119070 · ONC-BRST-2401