Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)

Study Overview
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Brief Summary
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The objectives of this qualitative study are to elicit concepts about symptoms that are important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts of symptoms on patients' day-to-day functioning.

Detailed Description
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In Step I, concept elicitation one-on-one interviews (via telephone or in person) will be conducted. The aims of the concept elicitation interviews are to: Identify the most common symptoms, as well as the most important symptoms, for patients with PSC, and Assess whether these symptoms impact day-to-day functioning An instrument will be developed based on the symptoms reported and in Step II of the study, the performance of the instrument will be assessed with further interviews.

Official Title
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Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)

Conditions
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Primary Sclerosing Cholangitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of PSC based on liver biopsy or diagnostic imaging, with diagnosis made at least three months prior to screening Patient report of PSC symptoms associated with PSC diagnosis Able to speak, read, and understand English Willing and able to provide written informed consent to participate in the research study Exclusion Criteria: Patients with other causes of liver or biliary disease, including viral hepatitis, alcoholic liver disease, primary biliary cirrhosis, and secondary sclerosing cholangitis Patient with history of liver cirrhosis Patients with history of cholangiocarcinoma Patients who have received a liver transplant Patients currently enrolled in PSC clinical trials; and STEP II ONLY: Enrolled in or participated in Step I of this study (concept elicitation)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Concept elicitation interviews (Step I)<br>Approximately 20 participants will be included. | |
| Cognitive interviews (Step II)<br>Approximately 30 participants will be included. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire | Interview participants to generate a list of the most common symptoms, as well as the most important symptoms, experienced by patients with PSC, and whether each symptom impacts day-to-day functioning. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary sclerosing cholangitis, PSC