Duke University Medical Center
Durham, North Carolina, 27710, United States
NCT Number: NCT03459352
A pilot study of an ePRO system in cancer patients receiving systemic therapies.
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Notify MeThe 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 12 months
total number of subjects that participate in the use of a web-based system
Duke University
Other
Feasibility Study of Digital Symptom Tracking, Patient Engagement and Quality of Life in Patients Seen in GI Oncology Clinic
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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.
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