Status:
RECRUITING
Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ankylosing Spondylitis
Autoimmune Disease
Eligibility:
All Genders
18+ years
Brief Summary
This study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhi...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the acceptability (e.g., ease of use, design, accessibility, content) of the educational tool that will be developed for patients with melanoma and pre-existing aut...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 2 2027
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04751396
Start Date
April 20 2022
End Date
February 2 2027
Last Update
November 7 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030