Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06083597
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-10-16
First Post:
2023-08-31
Brief Title:
Development of a Patient-reported Outcome Measure for Women With Chronic Pelvic Pain
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Development of a Patient-reported Outcome PRO Measure for Women With Chronic Pelvic Pain CPP
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
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:
PROM for CPP
Brief Summary:
The purpose of this study is to develop a patient questionnaire that can be utilized to assess the benefit of treatments of chronic pelvic pain in research studies
The information collected from a series of patient interviews will lead to the development of a questionnaire that accounts for the full impact of chronic pelvic pain from an affected womans perspective
The information collected from a series of patient interviews will lead to the development of a questionnaire that accounts for the full impact of chronic pelvic pain from an affected womans perspective
Detailed Description:
The purpose of this study is to develop a patient-reported outcome PRO instrument that can be utilized as an efficacy endpoint to assess medical and surgical treatments of chronic pelvic pain CPP in comparative outcomes research
This instrument will be developed consistent with Food and Drug Administration FDA guidance to be appropriate as an efficacy measurement in a clinical trial The development of such a PRO measure is iterative and this research protocol includes the qualitative research to develop a draft measure and document content validity Content validity is first assessed through concept elicitation interviews followed by cognitive interviews
Patients who are eligible and consent to participate will
1 complete a series of standardized health questionnaires
2 participate in an interview with a scientist who is an expert at developing this kind of PRO instrument who will ask patients about the impacts of their COO on their overall health and well being
The information collected from a series of these interviews will lead to the development of a draft questionnaire which will then be reviewed with additional women with similar causes of CPP as well as with women with other causes of CPP to determine its usability and accuracy at assessing the impacts of CPP on their health and well being
A final version of the PROM instrument will then be shared with women with CPP before and after any treatment to determine its ability to identify changes in their health and wellbeing
This instrument will be developed consistent with Food and Drug Administration FDA guidance to be appropriate as an efficacy measurement in a clinical trial The development of such a PRO measure is iterative and this research protocol includes the qualitative research to develop a draft measure and document content validity Content validity is first assessed through concept elicitation interviews followed by cognitive interviews
Patients who are eligible and consent to participate will
1 complete a series of standardized health questionnaires
2 participate in an interview with a scientist who is an expert at developing this kind of PRO instrument who will ask patients about the impacts of their COO on their overall health and well being
The information collected from a series of these interviews will lead to the development of a draft questionnaire which will then be reviewed with additional women with similar causes of CPP as well as with women with other causes of CPP to determine its usability and accuracy at assessing the impacts of CPP on their health and well being
A final version of the PROM instrument will then be shared with women with CPP before and after any treatment to determine its ability to identify changes in their health and wellbeing
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