Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management

Rectal Cancer Clinical Trial

Official title:

Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460822
• Other study ID #: 12-PAF07680
• Status: Completed
• Phase: N/A
• First received: October 22, 2014
• Last updated: December 22, 2015
• Start date: October 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colon Cancer
• Rectal Cancer

Intervention

Device:
• MyChemoCare iPad application

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	McKesson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient retention and engagement with the MyChemoCare application	The investigators will record enrollment, drop-off and daily engagement with the MyChemoCare app.	8 weeks post-enrollment	No
Primary	Patient satisfaction and usability of the MyChemoCare application	The investigators will use a 10-item survey developed by Dr. An to assess patients' experiences using the MyChemoCare app.	8 weeks post enrollment	No
Secondary	Physician compliance to study protocol	The investigators will assess how often physicians in the study use feedback from the MyChemoCare application.	8 weeks post-enrollment	No
Secondary	Mastery of cancer and chemotherapy symptoms	The investigators will use the Cancer Care Mastery Scale to assess patients' feelings of control over their cancer care.	8 weeks post enrollment	No
Secondary	Symptom burden	The investigators will use the MD Anderson Symptom Inventory (MDASI) to describe patient experiences in 13 core symptom areas.	8 weeks post enrollment	No
Secondary	Quality of Life	The investigators will use the FACT-G survey to assess four dimensions of patients health (physical, functional, social and emotional).	Baseline and 8 weeks post enrollment	No