Utility of a Mobile Application for Young Women With Breast Cancer

Wake Forest University (WFU)

Status: Not yet enrolling

Conditions: Breast Cancer; Cancer Distress

Treatments: Other: Mighty Pro Application

Study type: Interventional

Funder types: Other

Identifiers

NCT07009093

ONC-BRST-2401 (Other Identifier)

IRB00119070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Access to the Mighty Pro Application

Experimental group

Description:

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

Treatment:

Other: Mighty Pro Application

No Access to the Mighty Pro Application

No Intervention group

Description:

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