Development of a Patient-reported Outcome Measure for Women With Chronic

Status Enrolling by invitation

Clinical Trial 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 woman's perspective.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06083597
Study type	Observational
Source	Weill Medical College of Cornell University
Contact
Status	Enrolling by invitation
Phase
Start date	July 1, 2023
Completion date	December 31, 2024

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Development of a Patient-reported Outcome Measure for Women With Chronic Pelvic Pain — PROM for CPP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms