Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04055948
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2019-08-07
Brief Title:
Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Cancer Patients
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Patients With Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn whether an education and support program can help caregivers feel more confident in technical and communication skills needed to care for a person with cancer Patients with cancer and their caregivers face many challenges These include learning about cancer and its treatment coping with symptoms from illness and treatment side effects making adjustments to usual activities and managing the emotional effects of having a serious illness This study is testing whether different forms of education and support can help caregivers feel better prepared To find out if education about caregiving and different kinds of support are effective study personnel will compare approaches to help find ways to improve the services that are provided to caregivers during cancer treatment About 180 patients and their caregivers at the Seidman Cancer Center will take part in this study Participating in research is voluntary and this study is funded by the National Institute of Health
Detailed Description:
This is a 2-group prospective randomized controlled design to test the effect of an intervention as compared to a usual care control group on family caregivers CG outcomes patient outcomes and healthcare utilization outcomes during treatment
The objectives of this study are to
Evaluate the effect of a CG intervention as compared to a control group on CG primary anxiety and secondary depression health-related quality of life HRQOL and fatigue outcomes
Measure the effect of the intervention as compared to a control group on patient outcomes HRQOL and interrupted treatment course and healthcare utilization outcomes unplanned hospital admissions unplanned emergency room visits and unplanned use of intravenous IV fluids
Determine if CG self-efficacy mediates the effect of the intervention on CG anxiety
Determine if patient illness factors care demands hours per week spent caregiving and patient and CG demographic factors moderate the relationship between the intervention and CG outcomes
Compare the costs of healthcare utilization unplanned hospital admission unplanned emergency room visits and unplanned use of IV fluids between the intervention and control groups
The objectives of this study are to
Evaluate the effect of a CG intervention as compared to a control group on CG primary anxiety and secondary depression health-related quality of life HRQOL and fatigue outcomes
Measure the effect of the intervention as compared to a control group on patient outcomes HRQOL and interrupted treatment course and healthcare utilization outcomes unplanned hospital admissions unplanned emergency room visits and unplanned use of intravenous IV fluids
Determine if CG self-efficacy mediates the effect of the intervention on CG anxiety
Determine if patient illness factors care demands hours per week spent caregiving and patient and CG demographic factors moderate the relationship between the intervention and CG outcomes
Compare the costs of healthcare utilization unplanned hospital admission unplanned emergency room visits and unplanned use of IV fluids between the intervention and control groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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