Patient and Physician Perspectives on Non-Alcoholic Fatty Liver Disease

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04132440
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 24
• Location: 1
• Anticipated Duration (Months): 16.3
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

This trial studies patient and physician perspectives on non-alcoholic fatty liver disease. Using questionnaires and interviews, this trial may help researchers understand physicians' knowledge about the diagnosis, prognosis, treatment and management of non-alcoholic fatty liver disease, as well as gain an in-depth understanding of Hispanic patients' perceptions about the disease and investigate how cultural factors may play a role in its diagnosis, treatment and management.

Condition or Disease	Intervention/Treatment	Phase
Nonalcoholic Fatty Liver Disease; Physician	Other: Interview; Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:

1. Explore the perceptions of non-alcoholic fatty liver disease (NAFLD), including knowledge, current practices for diagnosis and management, and additional disease-related perceptions amongst both primary care physicians.

2. Explore the perceptions of NAFLD, including knowledge, diagnosis and management, and additional disease-related perceptions amongst Hispanic patients.

OUTLINE:

Patients and physicians complete a questionnaire over 5 minutes and an interview over 30-45 minutes about thoughts on NAFLD, including what they know about NAFLD and its diagnosis, management, and monitoring, and other thoughts on NAFLD.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 24 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Patient and Physician Perspectives on Non-Alcoholic Fatty Liver Disease (NAFLD)
• Actual Study Start Date: Aug 22, 2019
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Observational (questionnaire, interview) Patients and physicians complete a questionnaire over 5 minutes and an interview over 30-45 minutes about thoughts on NAFLD, including what they know about NAFLD and its diagnosis, management, and monitoring, and other thoughts on NAFLD.	Other: Interview; Complete interview; Other: Questionnaire Administration; Complete questionnaire

Outcome Measures

Primary Outcome Measures

1. Explore the perceptions of NAFLD, including knowledge, current practices for diagnosis and management, and additional disease-related perceptions amongst both primary care physicians (Questionnaire) [Up to 1 year]

2. Explore the perceptions of NAFLD, including knowledge, diagnosis and management, and additional disease-related perceptions amongst Hispanic patients. (Questionnaire) [Up to 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Be a self-reported practicing physician, who is a primary care physician (internal medicine, family medicine, etc.)

• Self-reported Hispanic ethnicity from the Greater Houston Metropolitan Area (patient)

• Have been diagnosed with NAFLD by a doctor (patient)

• Be an adult >/= 18 (patient)

• Able to speak English (patient)

Exclusion Criteria

-None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Lorna McNeill, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Texas MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT04132440
• Other Study ID Numbers: 2019-0262; NCI-2019-05886; 2019-0262
• First Posted: Oct 18, 2019
• Last Update Posted: Nov 13, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Nov 13, 2020