跳至主要内容
临床试验/NCT02460822
NCT02460822已完成不适用

Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management

University of Michigan1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Patient Satisfaction and Usability of the MyChemoCare Application

研究概览

简要总结

This research project addresses critical gaps in cancer symptom management through the creation of a mobile chemotherapy symptom management application. This application will assess for the presence and severity of common chemotherapy side-effects and provide personally tailored symptom-related video and narratives to enhance self-management of cancer and treatment-related symptoms. This study will examine patient acceptance and use of this mHealth application (called MyChemoCare) in a prospective trial of cancer patients (n=60) who are receiving chemotherapy for colorectal cancer at the University of Michigan Comprehensive Cancer Center.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed with colon or rectal cancer
  • •Expected to live at least 6 months
  • •Initiating chemotherapy for the first time in their treatment history
  • •Physically and mentally able to participate
  • •Able to read English
  • •Willing and able to sign informed consent

排除标准

  • •A treatment plan that does not include cytotoxic chemotherapy for colon or rectal cancer
  • •A medical history that includes cancer with the exception of in situ cancers of the cervix and basal cell cancers of the skin
  • •A current diagnosis that includes multiple cancers (this does not exclude metastatic disease)
  • •Received prior cytotoxic chemotherapy for any reason
  • •A diagnosed psychiatric disorder

研究组 & 干预措施

MyChemoCare

Experimental

Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.

干预措施: MyChemoCare iPad application (Device)

结局指标

主要结局

Patient Satisfaction and Usability of the MyChemoCare Application

时间窗: 8 weeks post enrollment

The investigators will use a 9-item survey developed by Dr. An to assess patients' experiences using the MyChemoCare app. This result is the mean of the the survey items (with opposite items reversed). The scale was scored from 0 = Strongly disagree to 6 = Strongly agree.

Patient Retention and Engagement With the MyChemoCare Application

时间窗: 8 weeks post-enrollment

Patient retention is defined as the number of patients who completed the 8-week study through the final evaluation. Engagement with the MyChemoCare application was measured as number of patients who checked in at least once per week of the study.

次要结局

  • Symptom Burden Reduction(8 weeks post enrollment)
  • Increased Mastery of Cancer and Chemotherapy Symptoms(8 weeks post enrollment)
  • Physician Use of the Study Feedback Mechanism(8 weeks post-enrollment)
  • Improved Quality of Life(Baseline and 8 weeks post enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lawrence C. An

Associate Professor of Internal Medicine

University of Michigan

研究点 (1)

Loading locations...

相似试验