Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283257
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2006-01-25
Brief Title:
Simultaneous Care Linking Palliation to Clinical Trials
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
A Randomized Control Trial That Teaches Oncology Clinical Trial Patients and Their Caregivers Problem Solving Skills
Status:
COMPLETED
Status Verified Date:
2017-06
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:
This is a multi-site randomized control trial taking place at six cancer centers UC Davis is the lead site Additional performance sites include the City of Hope Medical Center Fred Hutchinson Cancer Center at the Univ of Washington USC Norris Cancer Center UCSD Cancer Center and Johns Hopkins Cancer Center Clinical trial patients and their caregivers who are randomized to the intervention arm of the study are scheduled for three educational sessions The sessions focus on teaching problem solving skills based on the COPE problem solving model
Detailed Description:
The project introduces and evaluates the effects of a Simultaneous Care Education Intervention using the COPE model Creativity Optimism Planning and Expert Information developed by DZurilla and Nezu as one of its key components for cancer patients in Phase I II and III clinical trials The SCEI team will use the COPE problem solving educational model to instruct patients on how to problem solve and manage challenges associated not only with the investigational therapy but also the psychosocial issues that arise from cancer diagnosis disease progression treatment and disease or treatment related symptoms The educational intervention also sets up a system for regularly contacting the patient and caregiver in order to reinforce what is taught Patients and caregivers randomized to the intervention arm will receive three education sessions Patients and designated caregiver will be asked to complete the set of measurement tools approximately every 30 days while enrolled in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 CA 95260 | None | None | None |