Development of a Patient-reported Outcome (PRO) Measure for Women With Chronic Pelvic Pain (CPP)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pelvic Pain Syndrome
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Phase 1 qualitative concept elicitation interview
- Status
- Enrolling By Invitation
- Last Updated
- 4 months ago
Overview
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 woman's 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Pain symptoms should primarily be of pelvic and/or pelvic floor origin (inclusion criteria #3 above). Pain should not be exclusively low back, hips, symphysis, allodynia or hyperalgesia of the skin, or from varicose veins of the vulvar and/or lower extremities.
- •Pain thought primarily to be due to endometriosis, pelvic floor myalgia, a musculoskeletal etiology, irritable bowel disease, or painful bladder syndrome/interstitial cystitis.
- •Obvious endometriosis based on physical exam or laparoscopy findings.
- •Patients previously treated with a technically successful surgery or vascular procedure for a venous disorder of the pelvis or renal vein.
- •Participant has any clinically relevant medical condition (e.g., severe co morbid condition, severe mental illness, severe visual or auditory impairment, or cognitive impairment) that, in the opinion of the investigator, would interfere with participating in an interview and/or completing the study procedures
- •II. Second phase of study evaluation women with non-venous origin chronic pelvic pain
- •Inclusion Criteria :
- •Non-menopausal women ≥18 years old.
- •a. Women who are not menstruating because of ovarian suppression therapy for CPP are eligible.
- •CPP meeting the American College of Obstetricians and Gynecologists criteria.
Outcomes
Primary Outcomes
Phase 1 qualitative concept elicitation interview
Time Frame: 1 month
Phase 1 qualitative interview about VO-CPP (Chronic pelvic pain originating from venous contribution) signs, symptoms, and impacts, from which a novel VO-CPP questionnaire (PeVD HRQoL) will be drafted, and ultimately assessed for content validity in the Phase 2 interviews. This Phase 1 interview will be conducted with subjects with VO-CPP.
Secondary Outcomes
- Phase 2 Qualitative cognitive interview(1 month)
- Phase 2 qualitative cognitive interview(1 month)
- Phase 2 qualitative open-ended concept elicitation questions(1 month)