Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05385965
Status:
RECRUITING
Last Update Posted:
2024-01-26
First Post:
2022-04-27
Brief Title:
Meaning-Centered Pain Coping Skills Training for Cancer Pain
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Meaning-Centered Pain Coping Skills Training A Randomized Controlled Trial of a Psychosocial Intervention for Advanced Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-01
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:
MCPC
Brief Summary:
This study is a randomized controlled trial of a psychosocial pain management intervention called Meaning-Centered Pain Coping Skills Training MCPC Patients with advanced solid tumor cancer and pain interference N210 will be randomized to MCPC or a standard care control condition Patient-reported outcomes will be assessed at baseline and 8- and 12-week follow-ups 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 a debilitating symptom that greatly interferes with activities they care about Psychosocial interventions show promise for improving cancer-related pain however there is a lack of interventions that address existential and spiritual concerns eg a loss of meaning purpose and peace that are common among those facing high levels of pain interference from advanced cancer
To address this need an intervention called Meaning-Centered Pain Coping Skills Training MCPC was developed In this trial the investigators will randomize 210 patients to MCPC or enhanced usual care control Patient-reported outcomes will be assessed at baseline and 8- and 12-weeks after baseline As in the investigators extensive pilot work MCPCs four 45-to-60 minute individual weekly sessions will be delivered by trained study therapists via an accessible videoconference format Intervention sessions focus on training participants in evidence-based cognitive-behavioral skills such as guided imagery and activity pacing Emphasis is placed on using skills to reduce the degree to which pain interferes with participants sense of meaning purpose and peace
The first aim of this trial is to determine the efficacy of MCPC for reducing the primary outcome of pain interference at 8-weeks The second aim is to determine the efficacy of MCPC for improving secondary outcomes at 8-weeks The third aim is to test the maintenance of MCPCs effects on primary and secondary outcomes at 12-weeks The fourth aim is to estimate the cost-effectiveness of implementing MCPC
To address this need an intervention called Meaning-Centered Pain Coping Skills Training MCPC was developed In this trial the investigators will randomize 210 patients to MCPC or enhanced usual care control Patient-reported outcomes will be assessed at baseline and 8- and 12-weeks after baseline As in the investigators extensive pilot work MCPCs four 45-to-60 minute individual weekly sessions will be delivered by trained study therapists via an accessible videoconference format Intervention sessions focus on training participants in evidence-based cognitive-behavioral skills such as guided imagery and activity pacing Emphasis is placed on using skills to reduce the degree to which pain interferes with participants sense of meaning purpose and peace
The first aim of this trial is to determine the efficacy of MCPC for reducing the primary outcome of pain interference at 8-weeks The second aim is to determine the efficacy of MCPC for improving secondary outcomes at 8-weeks The third aim is to test the maintenance of MCPCs effects on primary and secondary outcomes at 12-weeks The fourth aim is to estimate the cost-effectiveness of implementing MCPC
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