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临床试验/NCT04324502
NCT04324502招募中不适用

Mobile Application to Collect PRO Data in NET Patients

King's College Hospital NHS Trust1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
Reporting compliance

研究概览

简要总结

Observational trial to assess the feasibility of monitoring patient reporting symptoms via mobile devices

详细描述

Neuroendocrine tumours (NET) are uncommon cancers with varied presentation. Patients are treated in specialist centres, and may sometimes have up to 4 lines of treatment; with the attendant complications. To date there has been no study capturing precisely patient reported outcomes (PROMs) and changes in QoL post treatment.

We have worked with the national patient charity and support group (Neuroendocrine Tumour Patient Foundation) and UKINETS, to develop a mobile application that will allow patients to capture details of their symptoms, as well as changes to quality of life during and post treatment. The application has been designed as an aide to patients, capturing details of their illness, treatment and interaction with the healthcare team (appointments).

This study aims to assess whether use of mobile app technology is helpful for patients undergoing medical and surgical therapy for neuroendocrine tumours. The trial is non-invasive and allows participants to record daily symptoms and raise alerts whilst they are undergoing different therapies. Health related quality of life during therapy will be assessed at specified times using EORTC validated questionnaires. The study also aims to investigate any difference in clinicians' response to PROMs; and the time taken to institute change, in any.

Participants are able to download the application from their mobile device app store from whichever location they wish, provided that they have regular internet access to download the app. Participants will be asked to provide daily responses pertaining to their health outcomes (PROs) in addition to completing validated quality of life questionnaires (EORTC CLQ - C30 and EORTC GINET21) at regular intervals over a 4 year period, prior to their treatment starting and throughout their treatment (months 0,3,6,12; and 6 monthly thereafter). This data will be stored in a research-specific database of de-identified patient-reported outcomes on quality of life and health.There are added features for participants to enter their medication information and appointments in the outpatient clinic; functionality to set reminders to take their medication; as well as reminders for upcoming hospital visits; and links to email addresses to contact their primary care teams. Clinicians are able to access the data to identify problems and track response to interventions.

The data will be stored in an encrypted format on the secure servers of Ampersand Health Ltd, who will export the data to the Chief Investigator at King's College Hospital at the end of the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Histologically confirmed diagnosis of a NET
  • Planned treatment for NET
  • Able to give informed consent
  • Able to understand the language of the questionnaires
  • A minimum expected survival of 6 months
  • All performance status is acceptable
  • 18 years of age or over

排除标准

  • Concurrent malignancies for which they are undergoing treatment
  • No smartphone / device
  • Any physical, psychological or comprehension problems that prevents completion of questionnaires.

结局指标

主要结局

Reporting compliance

时间窗: 4 years

The primary endpoint is patient reporting compliance, defined as the number of days with any patient report submitted during the course of treatment. This will be unique to each course of therapy since they have different durations of treatment.

次要结局

未报告次要终点

研究者

发起方
King's College Hospital NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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