Interleukin-2-Induced Cognitive/Affective/Sleep Symptoms

Completed

Conditions studied: Metastatic Renal Cell Carcinoma, Metastatic Melanoma, High-dose Interleukin-2

In brief

-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 cognition in the patient during their IL-2 treatment; and Aim 5) Evaluate procedures, data collected and analysis of data of interviews with the IL-2 patient to further discern what symptoms endorsed on the measurement scales represent and how they are characterized, and interviewing the primary nurse to gain any additional data on cognitive/affective symptoms observed in the IL-2 patient. Phase II (Investigating Cognitive, Affective and Sleep Alterations in Patients Receiving high dose IL-2 therapy): Up to 10 additional cases will be enrolled to understand cognitive, affective and sleep symptoms induced from IL-2 therapy in oncology patients with MM or metastatic RCC, and help design future studies to ameliorate these treatment-limiting symptoms. The specific aims of this study are to: Aim 1) Describe cognitive (language, concentration, mental fatigue, confusion, attention, short-term memory, and orientation), affective (depression, anxiety, mood alterations), and sleep disturbance symptoms in patients receiving 1 to 4 cycles (up to 8-weeks) of high-dose IL-2 therapy. Aim 2) Examine observed patient experiences of cognitive/affective/sleep symptoms from each patient's primary care partner, and primary nurse during 1 to 4 cycles of IL-2 therapy. Aim 3) Describe the trajectories of cognitive/affective/sleep symptoms in patients with MM or metastatic RCC undergoing 1 to 4 cycles of IL-2 therapy. Not all patients will receive 4 cycles of IL-2, because treatment will depend on a) disease progression and b) side effect toxicity; therefore, the symptom trajectory will be described for the cycles completed in situations where all cycles are not completed.

Key facts

Study ID

NCT02150369

Run by

Duke University

People needed

32

Starts

2015-02-16

Expected to finish

2017-03-02

Last updated by the study team

2017-05-31

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Previously documented cognitive disorder
• Congenital brain defects
• Traumatic brain injuries
• Primary care partner: defined as the primary family member or friend who will be staying with the patient at the hospital during the patient's IL-2 therapy OR is active in the patient's care. The IL-2 patient may have up to two primary care partners, for example a care partner for nights/days or alternating days. Care partners who are under 18 years may enroll if their parent is the IL-2 patient. For this study, the care partner must be at least 16 years old in order to participate because of the nature of the study. Their parent must be present and must consent for enrollment.
• Primary Nurse: will be identified by the unit or self-identified as the nurse who best "knows" the patient and his/her care. The primary nurse must be a Registered Nurse.

Where it is running

• Duke University Hospital — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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