Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management

NCT02460822 | Completed Results

• 1 other identifier: 12-PAF07680
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Patient Retention and Engagement With the MyChemoCare Application

  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.

  8 weeks post-enrollment

• Patient Satisfaction and Usability of the MyChemoCare Application

  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.

  8 weeks post enrollment

Secondary Outcomes (4)

• Physician Use of the Study Feedback Mechanism

  8 weeks post-enrollment

• Increased Mastery of Cancer and Chemotherapy Symptoms

  8 weeks post enrollment

• Symptom Burden Reduction

  8 weeks post enrollment

• Improved Quality of Life

  Baseline and 8 weeks post enrollment

Study Arms (1)

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.

Device: MyChemoCare iPad application

Interventions

MyChemoCare iPad application DEVICE

MyChemoCare

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• McKesson Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

This was a feasibility pilot study.

Results Point of Contact

• Title: Dr. Lawrence C. An
• Organization: University of Michigan

lcan@med.umich.edu

734-763-6099

Study Officials

• Larry C An, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: June 2, 2015
• Study Start: October 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 11, 2017
• Results First Posted: May 11, 2017

Record last verified: 2017-03

Locations

US (1)