Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management

NCT ID: NCT02460822

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-11-30

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.

Conditions

Colon Cancer; Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MyChemoCare

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.

Group Type: EXPERIMENTAL

MyChemoCare iPad application

Intervention Type: DEVICE

Interventions

MyChemoCare iPad application

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McKesson Foundation

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Lawrence C. An

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larry C An, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

12-PAF07680

Identifier Type: -

Identifier Source: org_study_id