Digital Symptom Tracking, Patient Engagement and Quality of Life in GI Oncology Clinic Patients



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/31/2018
Start Date:June 18, 2018
End Date:September 2019
Contact:Katherine Kalinowski, MSN
Email:kate.kalinowski@duke.edu
Phone:(919)684-6408

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Feasibility Study of Digital Symptom Tracking, Patient Engagement and Quality of Life in Patients Seen in GI Oncology Clinic

A pilot study of an ePRO system in cancer patients receiving systemic therapies.

The primary purpose of this pilot study is to determine the feasibility of the Noona
Healthcare Mobile PRO Application to describe oncology patient engagement using a web-based
symptom self-monitoring instrument. Additionally, the studyy will dentify side effects as
well as long term or chronic adverse events during and following cancer therapy based on the
United States (US) National Cancer Institute (NCI) Patient Reported Outcomes Common
Terminology Criteria for Adverse Events (PRO-CTCAE), and identify patients to participate in
future long-term Quality of Life studies following cancer therapy.

The study is not intended to compare outcomes between groups receiving different therapies.

Inclusion Criteria:

1. Individuals (men and women) aged 18 years or older

2. History cancer with no limitation on prior lines of therapy in the metastatic setting

3. ECOG performance status of 0-2

4. Estimated life expectancy of at least 12 months

5. Access to smartphone, tablet or computer with capability to utilize symptom-tracking
application

6. Willing and able to provide written, signed informed consent after the nature of the
study has been explained, and prior to any research-related procedures

7. Willing and able to comply with all study procedures

Exclusion Criteria:

1. Concurrent disease or condition that interferes with participation or safety

2. Non-English speaking, as the application is developed in the English language

3. Children will not be included in the study. The pattern of disease and symptoms are
different in children than in an adult population. The web-based tool was designed
based on the symptom experience of adults with cancer.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-684-0132
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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