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Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors

NCT ID: NCT04751396
Registry status: Recruiting
Study type: Observational
Sponsor: M.D. Anderson Cancer Center
Conditions: Ankylosing Spondylitis, Autoimmune Disease, Crohn Disease, Enteropathic Arthritis, Enteropathic Spondylitis, Inflammatory Bowel Disease, Melanoma, Psoriasis, Psoriatic Arthritis, Reactive Arthritis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Ulcerative Colitis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Testing of an Educational Tool for Patients With Melanoma and Concomitant Autoimmune Disease Who Are Candidates for Adjuvant Therapy With Immune Checkpoint Inhibitors: Acceptability and Usability With Patients and Providers

Enrollment: 125 participants (Estimated).

What is being studied

Other: Best Practice
Intervention: Child Health Services
Intervention: Community Health Services
Intervention: Data Collection
Intervention: Early Intervention, Educational
Other: Educational Intervention
Intervention: Educational Status
Intervention: Environment and Public Health
Intervention: Epidemiologic Methods
Intervention: Guidelines as Topic
Intervention: Health Care Evaluation Mechanisms
Intervention: Health Care Facilities Workforce and Services
Intervention: Health Care Quality, Access, and Evaluation
Intervention: Health Services
Intervention: Health Services Administration
Other: Interview
Intervention: Interviews as Topic
Intervention: Investigative Techniques
Intervention: Methods
Intervention: Population Characteristics
Intervention: Practice Guidelines as Topic
Intervention: Preventive Health Services
Intervention: Public Health
Intervention: Quality Assurance, Health Care
Intervention: Quality Indicators, Health Care
Intervention: Quality of Health Care
Other: Questionnaire Administration
Intervention: Socioeconomic Factors
Intervention: Standard of Care
Other: Survey Administration

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Diagnosis of melanoma * Diagnosis of pre-existing autoimmune disease * Inflammatory bowel disease * Diagnosis of Crohn's disease or ulcerative colitis by a gastroenterologist * For ulcerative colitis, proof of chronic changes over time (i.e., 6 months) and signs of inflammation histologically * Treatment with aminosalicylates, corticosteroids, thiopurines, or immune modifiers (e.g., calcineurin inhibitors, methotrexate, adhesion molecule antagonists) * Rheumatoid arthritis * Diagnosis of rheumatoid arthritis by a rheumatologist * Treatment with traditional disease-modifying antirheumatic drugs (e.g., methotrexate, sulfasalazine, hydroxychloroquine) or targeted therapy * Systemic lupus erythematosus * Diagnosis of systemic lupus erythematosus by a rheumatologist * Psoriasis * Diagnosis of psoriasis by a dermatologist * Treatment with corticosteroids, vitamin D analogs, anthralin, topical retinoids, calcineurin inhibitors, salicylic acid, coal tar, or moisturizers; light therapy, including sunlight, ultraviolet B (UVB) phototherapy, narrowband UVB therapy, Goeckerman therapy, photochemotherapy, excimer laser, or pulsed dye laser; or systemic medications, including retinoids, methotrexate, cyclosporine, hydroxyurea, or thioguanine or targeted therapies * Spondyloarthropathies * Diagnosis of ankylosing spondylitis, reactive arthritis, psoriatic arthritis, or enteropathic arthritis/spondylitis by a rheumatologist * Treatment with disease-modifying antirheumatic drugs (e.g., sulfasalazine) or targeted therapy * Age of 18 years or older * Patients whose physicians had recommended they begin using any of the currently available immune checkpoint inhibitors or people who are in the midst of or have already made the decision on whether or not start an immune checkpoint inhibitor * E-mail access and computer with Internet access or telephone * Ability to communicate in English or Spanish * CLINICIAN * Prescribed immune checkpoint inhibitors * Are providing care for patients with melanoma * In the clinics at MD Anderson

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

Texas, United States: 1

Sample of listed locations

M D Anderson Cancer Center — Houston, Texas, 77030, United States — Recruiting

Study details

Start date: April 20, 2022
Primary completion date: February 2, 2027
Completion date: February 2, 2027
First posted: February 12, 2021
Collaborators: National Cancer Institute (NCI)

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT04751396
Registry last updated: May 20, 2026
QualifiedStudies registry data refreshed: October 2, 2026
QualifiedStudies record fetched: October 2, 2026

View NCT04751396 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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