Interleukin-2-Induced Cognitive/Affective/Sleep Symptoms

NCT02150369 | Completed

• 1 other identifier: Pro00053989
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Participant enrollment

  Phase I: Participant enrollment will be evaluated by determining the difficulty of recruitment and enrollment of one case, comprised of the IL-2 patient, their care partner and their primary nurse. To determine enrollment difficulty, the time taken to enroll one case will be recorded.

  6 months

Secondary Outcomes (1)

• Participant burnout

  1 months

Other Outcomes (12)

• Participant burden

  1 months

• Cognitive Symptoms I

  4 months

• Cognitive Symptoms II

  4 months

Study Arms (1)

Patient, care partner, primary nurse case

In Phase I of this pilot, a case is comprised of the metastatic RCC patient receiving IL-2, their care partner, and their primary nurse. In Phase II, the IL-2 patient can either have MM or metastatic RCC. The care partner for this study will be the family member or friend staying with the IL-2 patient throughout treatment.

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be recruited from Duke University Hospital (Duke North) in Durham, NC.

You may qualify if:

• Persons diagnosed with metastatic RCC/MM (stage III or stage IV) disease
• years of age
• English speaking and literate
• Receiving HD IL-2 (720,000 IU/kg of IL-2 IV q8hr for a total of 14 doses per cycle) therapy at Duke University Hospital
• Must have a care partner (family member or friend) active in their care during IL-2 treatments

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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Related Links

• RCC and high-dose IL-2

MeSH Terms

Conditions

Carcinoma, Renal Cell; Melanoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robin B. Knobel, PhD, RN

  Duke University

  PRINCIPAL INVESTIGATOR

• Donald E. Bailey, PhD, RN, FAAN

  Duke University

  STUDY CHAIR

• Tara K. Mann, RN

  Duke University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 29, 2014
• Study Start: February 16, 2015
• Primary Completion: March 2, 2017
• Study Completion: March 2, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-03

Locations

US (1)