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临床试验/NCT04262518
NCT04262518Unknown不适用

Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients

Outcomes4Me1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2020年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
125
试验地点
1
主要终点
Measure # of times a patient logs into the Outcomes4Me app over a 12 week period

研究概览

简要总结

This study aims to investigate the role of a mobile health app, Outcomes4Me, in the navigation of care for people with breast cancer.

详细描述

This protocol is a single arm pilot study of a novel breast cancer navigation app that is intended to assist patients with breast cancer understand their diagnosis and treatment options (both as part of standard of care practice and clinical trials) and manage their care, through treatment and symptom tracking. Patients will also be able to share information and get news via the app relevant to their cancer subtype. Results from this intervention will inform future clinical integration efforts, improve patient-centeredness of such an app-based health content and data platform, and inform the design of a larger, randomized study to demonstrate an improvement in patients' outcomes as well as enhanced Real-World Evidence (RWE) data collection.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 years or older, with histologically or cytologically confirmed invasive breast cancer stage I-IV
  • •Must be on, or planning to be on within 4 weeks of registration, active therapy, with the intent to receive some element of active therapy > 28 days after registration
  • •Must be able to understand, read, and write in English and be able to sign informed consent
  • •Must have an Apple or Android smart phone that they are able to use and download the Outcomes4Me app on
  • •Must have the ability to access the internet at least once per week via their smart phone (having a computer is not required)

排除标准

  • •Participations seen for consultation opinion only and are not planning to receive some element of active treatment from an MGH medical or radiation oncology provider at MGH (Boston or Waltham sites) during the 12-week study period

研究组 & 干预措施

Outcomes4Me App Users

Other

This cohort will download and use the Outcomes4Me mobile app for breast cancer.

干预措施: Outcomes4Me Mobile App (Device)

结局指标

主要结局

Measure # of times a patient logs into the Outcomes4Me app over a 12 week period

时间窗: 12 Weeks

We will track engagement with the app by tracking the number of times a user logs in to the Outcomes4Me app over a 12 week period. The app will be considered feasible if at least 40% of enrolled patients engage with the Outcomes4Me app at least 3 times during the 12-week study period.

次要结局

  • Measure System-Usability Score (SUS) of app usage(12 weeks)
  • Measure Net-Promoter Score (NPS) of app usage(12 weeks)

研究者

发起方
Outcomes4Me
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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