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Clinical Trials/NCT02460822
NCT02460822
Completed
Not Applicable

Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management

University of Michigan1 site in 1 country16 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colon Cancer
Sponsor
University of Michigan
Enrollment
16
Locations
1
Primary Endpoint
Patient Satisfaction and Usability of the MyChemoCare Application
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
November 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lawrence C. An

Associate Professor of Internal Medicine

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Patient Satisfaction and Usability of the MyChemoCare Application

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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