Interleukin-2-Induced Cognitive/Affective/Sleep Symptoms

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 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.

Conditions

• Metastatic Renal Cell Carcinoma
• Metastatic Melanoma
• High-dose Interleukin-2

Sponsors & Collaborators

• Duke University

  lead OTHER

Principal Investigators

• Robin B. Knobel, PhD, RN · Duke University

• Donald E. Bailey, PhD, RN, FAAN · Duke University

• Tara K. Mann, RN · Duke University

Eligibility

Min Age

16 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-16

Primary Completion

2017-03-02

Completion

2017-03-02

Countries

• United States

Study Locations