This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and/or effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients.
PRIMARY OBJECTIVE: I. Determine the change in patient-reported rating of Cancer Connected Access and Remote Expertise (CARE) after 8 weeks in clinic compared to the same rating after 8 weeks at home. SECONDARY OBJECTIVES: I. Evaluate patient preference for location of cancer treatment administration, in the clinic or in the home. II. Longitudinally assess patient-reported function and global health/quality of life. III. Longitudinally assess patient-reported symptoms. IV. Assess the safety of cancer directed therapy when administered at home by a home health provider with remote patient monitoring and command center support. V. Describe emergency room visits and hospitalizations over the course of the study. VI. Describe overall survival (data collected out to 1 year). TERTIARY OBJECTIVE: I. Assess the cost outcomes related to patient treatment in the clinic or in the home. OUTLINE: Patients receive nivolumab SC on day 1 of each cycle. Cycles repeat every 28 days in clinic for 2 cycles, then at home by a home health nursing provider (HHNP) for 4 cycles, followed by either in-clinic or at-home administration for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive in-home visits by a home health nurse, undergo remote patient monitoring including vital sign measurements and condition-specific symptom assessments throughout the study. After completion of study treatment, patients are followed up at days 30 and 100, then every 3 months for up to 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Receive in-home visits by a home health nurse
Given SC
Undergo remote patient monitoring
Ancillary studies
Mayo Clinic in Florida
Jacksonville, Florida, United States
RECRUITINGChange in patient-reported rating of Cancer CARE Cancer Connected Access and Remote Expertise (CARE) after 8 weeks
Measured using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey assessing "your overall cancer care experience," answered on a scale of 0-10 where 0 is the worst experience possible and 10 is the best experience possible. The change in patient-reported rating of Cancer CARE after 8 weeks of in clinic care to the same rating after 8 weeks of at home care will be compared.
Time frame: At baseline and up to 24 weeks of in clinic or at home care
Patient preferred treatment location
The proportion of patients who prefer care at home or express no preference will be computed and compared with the proportion of patients who prefer care in the clinic.
Time frame: Up to 24 weeks
Patient level of comfort with receiving injections at home
The proportion of patients who express comfort will be tabulated and a proportion greater than 70% will signify acceptance. Likert patient feedback questions and "Was It Worth It" questions will be described using frequencies and relative frequencies by arm. Numeric analog scale questions will be described using means and standard deviations and compared within patients (if applicable) using paired t-tests. Descriptive estimates at 24 weeks (after 8 weeks of in clinic and 16 weeks of at home care) will be generated throughout.
Time frame: Up to 24 weeks
Patient-reported symptoms - PRO-CTCAE
Patient-reported symptoms will be measured using the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). In this study, PRO-CTCAE items were chosen based on common symptoms experienced across cancer patients and side effects common with nivolumab. A free-text item will also be included for patients to report other symptoms as willing. Adverse events (AEs) will be tabulated during the 8 weeks in clinic, and during the 8 weeks at home, compared between arms and summarized over the 24 weeks.
Time frame: Up to 24 weeks
Patient-reported function - EORTC QLQ-F17
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Function 17 (EORTC QLQ-F17), a 17-item patient-reported questionnaire about patient ability to function, overall health and quality of life, and perceived financial impact of cancer and its treatment. The first 15 questions are answered on a scale of 1-4 where 1=not at all, 2=a little, 3=quite a bit, and 4=very much. The final two questions (overall health and overall quality of life during the past week) are answered on a 1-7 numeric analogue scale where 1=very poor and 7=excellent.
Time frame: Baseline; 8 weeks; 16 weeks; 24 weeks
Patient-reported side effect impact - GP5
Assessed using the Functional Assessment of Chronic Illness Therapy (FACIT) - Item GP5, "I am bothered by side effects of treatment," which is answered on a scale ranging from 0 (Not at all) to 4 (Very Much). Responses will be computed and compared across patients visits. Mean GP5 scores over time will also be explored.
Time frame: After 8 weeks of in-clinic and 8 weeks of at home care
Incidence of Adverse Events (AEs)
The maximum grade for each type of AE will be summarized using Common Terminology Criteria for Adverse Events version 5.0. The frequency and percentage of grade 3+ AEs will be reported and compared using McNemar's test.
Time frame: At 8 weeks of in-clinic and 8 weeks at home care
Emergency room visits and hospitalizations
The proportion of patients with an emergency room visit or hospitalization will be computed and compared using McNemar's test. Proportion of patients with emergency room visits or hospitalizations will also be summarized over the entire study.
Time frame: At 8 weeks of in-clinic and at 8 weeks of at home care
Overall survival (OS)
OS is defined as the time from study entry to death from any cause. OS will be estimated using the Kaplan-Meier method.
Time frame: Up to one year post study completion
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