Utility of a Mobile Application for Young Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Stage 1: Feasibility of Implementation of Mighty Pro App
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and willingness to sign an IRB-approved informed consent
- •Age ≥ 18 and ≤ 45 years at the time of consent
- •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
排除标准
- 未提供
研究组 & 干预措施
Access to the Mighty Pro Application
Participants will be given access to the Mighty Pro Application for 12 months.
干预措施: Mighty Pro Application (Other)
No Access to the Mighty Pro Application
Participants will not be given access to the Mighty Pro Application.
结局指标
主要结局
Stage 1: Feasibility of Implementation of Mighty Pro App
时间窗: 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
时间窗: 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).
次要结局
- 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)