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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459352
• Other study ID #: Pro00092471
• Status: Completed
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: April 4, 2020

Study information

• Verified date: September 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 4, 2020
• Est. primary completion date: April 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• ePRO
Patients will be instructed to log symptoms with an ePRO app using their own personal devices, and prompted once per month for 12 months to log symptoms. These participants will be sent an Adverse Event Questionnaire (AEQ) via the Noona tool that summarizes their symptoms and distress once per month and one week prior to any medically indicated oncology clinic visit. Symptoms designated as clinically severe either during regular symptom logging or via the AEQ will trigger a prompt to contact the clinical team for immediate follow-up. Participants will complete a follow-up questionnaire at 6 months and 12 months following enrollment that includes a self-report of symptom burden, HRQOL, and satisfaction.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Noona Healthcare Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject participation	total number of subjects that participate in the use of a web-based system	12 months