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| Name | Class |
|---|---|
| Noona Healthcare Inc | UNKNOWN |
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A pilot study of an ePRO system in cancer patients receiving systemic therapies.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject participation | total number of subjects that participate in the use of a web-based system | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. Kim Lyerly, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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