Ignite Creation Date:
2024-05-06 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03557515
Status:
COMPLETED
Last Update Posted:
2021-05-26
First Post:
2018-05-22
Brief Title:
Reducing Distress in Phase 1 Trial Caregivers The P1-CaLL Study
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Reducing Distress in Phase 1 Trial Caregivers The P1-CaLL Study
Status:
COMPLETED
Status Verified Date:
2021-05
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 study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial
Detailed Description:
This study seeks to decrease distress in the lives of the caregivers who are helping cancer patients who have entered a phase 1 clinical trial The P1-CaLL study uses a psychosocial intervention aimed at decreasing distress through the utilization of adaptive coping strategies eg meditation emotion-focused coping and cognitive behavioral techniques Caregivers will receive 4 weeks of stress-management sessions over the phone Then they will be randomized to receive 4 more weekly sessions of either Cognitive Behavioral Therapy or Metta-Meditation over the phone Participants will receive tasks to complete each week
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