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OpenTrials
Completed

NCT Number: NCT03459352

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Noona web-based platform

Primary outcomes

  1. Subject participation

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Noona Healthcare Inc

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2018
Registry last updated
Aug 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.