Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549985
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Interdisciplinary Group Care for the Treatment of Endometriosis-associated Pain the Peer Empowered Endometriosis Pain Support PEEPS Pilot Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEEPS RCT
Brief Summary:
The goal of this clinical trial is to determine if Peer Empowered Endometriosis Pain Support PEEPS an 8-week interdisciplinary integrative group care program decreases pain interference in participants with endometriosis-associated chronic pelvic pain between the ages 18 and 48 The main question we aim to answer is
Is PEEPS more effective than Education in decreasing pain interference
Researchers will compare people receiving PEEPS plus usual care to those receiving Education plus usual care to see if people participating in PEEPS demonstrate improvements in pain physical function and quality of life
Participants will
Complete baseline quality of life surveys
Participate in an 8-session group care program
Provide feedback on each session and the program globally
Complete follow up quality of life surveys at PEEPS completion 6- and 12-months post-completion
A sub-set will complete semi-structured interviews or focus groups about the experience of participating in PEEPS
Is PEEPS more effective than Education in decreasing pain interference
Researchers will compare people receiving PEEPS plus usual care to those receiving Education plus usual care to see if people participating in PEEPS demonstrate improvements in pain physical function and quality of life
Participants will
Complete baseline quality of life surveys
Participate in an 8-session group care program
Provide feedback on each session and the program globally
Complete follow up quality of life surveys at PEEPS completion 6- and 12-months post-completion
A sub-set will complete semi-structured interviews or focus groups about the experience of participating in PEEPS
Detailed Description:
None
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