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NCT02150369 · ClinicalTrials.gov registry record
Interleukin-2-Induced Cognitive/Affective/Sleep Symptoms
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 32
- Enrollment target
NCT02150369 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 32 participants.
The verdict
NCT02150369 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
Study Summary
-Purpose: Phase I: To test the methods, data collection and analysis in a study to evaluate cognitive/affective/sleep symptoms in one patient undergoing treatment with high-dose Interleukin-2 (IL-2) for metastatic renal cell carcinoma (RCC), their informal caregiver and their primary nurse. Phase II: A pilot study examining up to 10 IL-2 cases to describe cognitive/affective/sleep symptoms of patients receiving high-dose IL-2 therapy for metastatic melanoma (MM) or metastatic RCC in order to develop interventional studies to minimize these symptoms. -Aims: In this pilot, a case is comprised of the metastatic RCC patient receiving IL-2, their care partner, and their primary nurse. The care partner for this study will be the family member or friend staying with the IL-2 patient throughout treatment. Phase I (Evaluation of Methods and Procedures): One case will be examined to evaluate the methods, data collection and analysis to be used in this study. The aims of Phase I of this study are to: Aim 1) Evaluate recruitment and enrollment procedures to enroll one IL-2 case, comprised of the IL-2 patient, their care partner and their primary nurse; Aim 2) Evaluate administration procedures, data collected, and analysis of four questionnaire scales to detect the trajectory of cognition \[Attentional Function Index and Montreal Cognitive Assessment\] and affect \[Hamilton Anxiety scale and Inventory of Depressive Symptomatology-Clinician\] in the IL-2 patient from the start to the end of a cycle of treatment; Aim 3) Evaluate procedures, data collected and analysis of journal entries from the care partner who are to record their thoughts, observations, and feelings concerning any changes in the patient's behavior or cognition during IL-2 treatment every 8 hours; Aim 4) Evaluate procedures, data collected and analysis of semi-structured questionnaires completed by the primary nurse taking care of the patient receiving IL-2 which will describe any changes in behavior or cogn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-02-16 |
| Est. Completion | 2017-03-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02150369
The ClinicalTrials.gov registry entry for NCT02150369 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT02150369 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02150369 about?
NCT02150369 is a clinical study titled "Interleukin-2-Induced Cognitive/Affective/Sleep Symptoms". -Purpose: Phase I: To test the methods, data collection and analysis in a study to evaluate cognitive/affective/sleep symptoms in one patient undergoing treatment with high-dose Interleukin-2 (IL-2) for metastatic renal cell carcinoma (RCC), their informal caregiver and their primary nurse. Phase I...
What is the current status of trial NCT02150369?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2015-02-16. Estimated completion is 2017-03-02.
Who is sponsoring clinical trial NCT02150369?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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