Quality of Life in Patients With Primary Sclerosing Cholangitis (QOL in PSC)

Duke University

Status: Completed

Conditions: Primary Sclerosing Cholangitis

Treatments: Other: quality of life survey

Study type: Interventional

Funder types: Other

Identifiers

NCT02712736

Pro00069683

Details and patient eligibility

About

The purpose of this study is to assess the healthcare-related quality of life (HRQOL), the impact of risk of liver transplant and risk of malignancy on HRQOL, and the complementary and alternative medicine use in patients with PSC.

Full description

A cohort of adult (age ≥ 18) patients with a diagnosis of PSC will be identified. The patients will be approached about participating in the study while at their appointment, either by the investigators or someone else known to the patient. If the patient agrees, the investigators or other key personnel will then provide information about the study and obtain their informed consent to participate.

The patients who consent to participate will be sent home from the clinic with a survey to complete and return via mail in a provided addressed, stamped envelope. The survey consists of the Short Form-36 (SF-36), the Chronic Liver Disease Questionnaire (CLDQ), questions from the PROMIS SexFs v2.0, questions regarding perceived risk for liver transplant, cholangiocarcinoma, and colorectal carcinoma, as well as perceived overall life expectancy, and questions regarding complementary and alternative medicine use.

Demographic information and clinical data will also be obtained from the patient's electronic medical record. The study will be cross-sectional in nature, and there will be no follow-up with the subjects after the survey is completed.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (age ≥ 18) patients with PSC, confirmed by laboratory tests, imaging, and/or liver biopsy

Exclusion criteria

• Patients <18
• Patients who have undergone liver transplant, patients with frank hepatic encephalopathy
• Patients with active inflammatory bowel disease (IBD) flares
• Patients with malignancies
• Patients unable to understand English
• Patients refusing to participate or provide informed consent

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

102 participants in 1 patient group

Survey respondents

Other group

Description:

The patients who consent to participate will be sent home from the clinic with a survey to complete and return via mail in a provided addressed, stamped envelope. The survey consists of the Short Form-36 (SF-36), the Chronic Liver Disease Questionnaire (CLDQ), questions from the PROMIS SexFs v2.0, questions regarding perceived risk for liver transplant, cholangiocarcinoma, and colorectal carcinoma, as well as perceived overall life expectancy, and questions regarding complementary and alternative medicine use.

Treatment:

Other: quality of life survey