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临床试验/NCT05724966
NCT05724966已完成不适用

Anti-neoplastic Treatment, Based on PRO Data Reported Through a MHealth App Solution in Multiple Myeloma - a Mixed Method Study

Thomas Lund1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
1
主要终点
patient registration of side effects using an app

研究概览

简要总结

Pirmary endpoint: to examine the feasibility of using an mHealth app for reporting of side effects instead of a telephone call from the hospital staff together with examining the perspectives of patients with multiple myeloma and healthcare professionals of this new method for reporting side effects, and to assess organizational aspects. Usual procedure to assess side effect prior to cancer treatment with Bortezomib is a telephone call the day before. With this innovative method investigator aimed to give the patient more independence in their daily life and in that way improve their quality of life.

详细描述

It is a prospective, clinical, parallel mixed-method design with a quantitative core and a qulitative supplementary component. There will be used a Mhealth app called "My Hospital".

Quantitative data will be acquired from time registrations performed by patients and nurses and will be descriptively analyzed applying a micro-costing approach, using cost data per individual. Qualitative data will be obtained from individual, semi-structured interviews with patients and one focus group interview with healthcare professionals and will be analyzed applying a hermeneutic approach.

Eligible for inclusion were patients with MM scheduled for Bortezomib. Moreover, patients should have access to a smartphone, be able to self-report side effects of Bortezomib using a smartphone app, and be willing to participate in a semi-structured interview.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with MM scheduled for Bortezomib
  • patients should have access to a smartphone
  • patients should be able to self-report side effects of Bortezomib using a smartphone app, and be willing to participate in a semi-structured interview.

排除标准

  • patients had to talk and read danish

结局指标

主要结局

patient registration of side effects using an app

时间窗: 18 months

PRO data

Time registrations of side effects using an app

时间窗: 18 months

PRO data (time registrations of side effects using an app)

次要结局

  • Qualitative perspectives interview(16 months)

研究者

发起方
Thomas Lund
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Thomas Lund

MD

Odense University Hospital

研究点 (1)

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