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

NCT03459352 | Completed

• 1 other identifier: Pro00092471
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Keywords

Cancer; Patient Reported Outcomes; Symptom management

Outcome Measures

Primary Outcomes (1)

• Subject participation

  total number of subjects that participate in the use of a web-based system

  12 months

Study Arms (1)

ePRO

EXPERIMENTAL

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.

Other: ePRO

Interventions

ePRO OTHER

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.

Also known as: Noona web-based platform

ePRO

Eligibility Criteria

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

You may qualify if:

• Individuals (men and women) aged 18 years or older
• History cancer with no limitation on prior lines of therapy in the metastatic setting
• ECOG performance status of 0-2
• Estimated life expectancy of at least 12 months
• Access to smartphone, tablet or computer with capability to utilize symptom-tracking application
• 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
• Willing and able to comply with all study procedures

You may not qualify if:

• Concurrent disease or condition that interferes with participation or safety
• Non-English speaking, as the application is developed in the English language
• 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.

Sponsors & Collaborators

• Duke University: lead
• Noona Healthcare Inc: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• H. Kim Lyerly, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 8, 2018
• Study Start: June 18, 2018
• Primary Completion: April 4, 2020
• Study Completion: April 4, 2020
• Last Updated: August 26, 2020

Record last verified: 2019-09

Locations

US (1)