Ignite Creation Date:
2024-05-06 @ 2:49 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04431830
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2020-06-11
Brief Title:
Meaning-Centered Pain Coping Skills Training
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Meaning-Centered Pain Coping Skills Training A Randomized Pilot Trial for Patients With Advanced Cancer and Pain
Status:
COMPLETED
Status Verified Date:
2022-05
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 is a randomized clinical trial of a psychosocial pain management intervention called Meaning-Centered Pain Coping Skills Training MCPC Patients with advanced solid tumor cancer and at least moderate pain will be randomized to MCPC or a standard care control condition Patient-reported outcomes will be assessed at baseline and 5- and 10-week follow-ups The first aim of this study is to assess the feasibility of conducting a randomized clinical trial to test MCPC The second aim is to characterize MCPCs effects on patient-reported outcomes of pain severity pain interference meaning in life self-efficacy for pain management and psychological distress The third aim is to describe participants experiences of MCPC using semi-structured qualitative interviews The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention eg loss of confidentiality
Detailed Description:
Many patients with advanced cancer describe pain as their most feared and distressing symptom In this population higher pain levels often predict worse physical emotional and existentialspiritual well-being Psychosocial interventions show promise for improving cancer-related pain however no interventions address existential concerns eg a loss of meaning in life that are common among those facing pain from advanced illness To address this need an intervention called Meaning-Centered Pain Coping Skills Training MCPC was developed MCPC seeks to teach patients cognitive and behavioral skills for managing pain eg guided imagery in order to help them engage with what gives their life a sense of meaning purpose and significance
This pilot study is being conducted to prepare for a large-scale clinical trial that will test the efficacy of MCPC for improving patients pain and pain-related outcomes
This pilot study is being conducted to prepare for a large-scale clinical trial that will test the efficacy of MCPC for improving patients pain and pain-related outcomes
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