Ignite Creation Date:
2024-05-06 @ 7:39 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02577237
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2015-10-14
Brief Title:
Building Caregiver Skills Using a Simulation-based Intervention for Care of Head and Neck Cancer
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 Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2019-02
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:
Patients with head and neck 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 tests whether different forms of education and support can help family caregivers feel better prepared To find out if education about caregiving and different kinds of support are effective this study wants to compare approachesOne group includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses The other group receives an educational booklet about caregiving in addition to usual care by their doctors and nurses The caregiver also completes surveys about his or her emotions distress confidence as a care giver and quality of life In addition the study asks the caregiver questions about his or her age race ethnicity marital status employment status education annual household income and current living arrangements This pilot study will only be offered at the Case Medical Center University Hospitals Seidman Cancer Center Case Comprehensive Cancer Center Main Campus
Detailed Description:
Aim 1 Conduct a pilot test of the effects of a novel caregiver intervention as compared to a control group on family caregiver self-efficacy for caregiving anxiety depression and health-related quality of life
Aim 2 Explore the acceptability of a caregiver intervention that utilizes simulation
Aim 3 Assess the feasibility of the intervention Aim 4 Describe the incidence of patient events that may be impacted by caregiver self-efficacy such as acute care visits admissions to the hospital visits to the emergency department need for fluids in the radiation oncology department and interrupted treatment course
Aim 2 Explore the acceptability of a caregiver intervention that utilizes simulation
Aim 3 Assess the feasibility of the intervention Aim 4 Describe the incidence of patient events that may be impacted by caregiver self-efficacy such as acute care visits admissions to the hospital visits to the emergency department need for fluids in the radiation oncology department and interrupted treatment course
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