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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: ePRO

• Registration Number: NCT03459352
• Lead Sponsor: Duke University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Study Start: 2018-06-18
• Status Verified: 2019-09
• Primary Completion: 2020-04-04
• Study Completion: 2020-04-04
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ePRO	ePRO	There is no therapeutic intervention. Patients will use ePRO system to report systems. We will describe use in patients to determine compliance in reporting symptoms.

Primary Outcome Measures

Name	Time	Method
Subject participation	12 months	total number of subjects that participate in the use of a web-based system

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States