Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265285
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-02
Brief Title:
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE Connected Access and Remote Expertise Beyond Walls CCBW Program
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Pilot Single-Arm Pragmatic Trial of In-Home Versus In-Clinic Subcutaneous Nivolumab Administration Through Cancer CARE Connected Access and Remote Expertise Beyond Walls CCBW Program
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients
Detailed Description:
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 healthquality 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 study
After completion of study treatment patients are followed up at days 30 and 100 then every 3 months for up to 1 year
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 healthquality 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-00637 | REGISTRY | None | None |
| 23-009663 | OTHER | None | None |
| MC230716 | OTHER | Mayo Clinic in Florida | None |