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

Launched by M.D. ANDERSON CANCER CENTER · Feb 8, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring how well an educational tool can help patients with melanoma who also have existing autoimmune diseases understand their treatment options involving immune checkpoint inhibitors. Immune checkpoint inhibitors are a type of medication that can help the body’s immune system fight cancer, but they may have different effects on patients with autoimmune diseases. The researchers want to hear from patients about how easy the tool is to use and whether the information it provides is helpful. This feedback will be used to improve the educational materials to support better decision-making for future treatments.

To participate in this study, patients must be 18 years or older and have a diagnosis of both melanoma and a specific autoimmune disease, such as rheumatoid arthritis or inflammatory bowel disease. Participants should also have access to email and the internet or a telephone, and be able to communicate in English or Spanish. Those who join can expect to share their thoughts on the educational tool, which will ultimately help improve resources for others in similar situations. The trial is currently recruiting participants and aims to make sure that patients feel informed and supported in their treatment choices.

Gender

ALL

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