Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
Recruiting · NCT04751396 · Observational (researchers observe without assigning treatment) · Lead sponsor: M.D. Anderson Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
Best PracticeEducational InterventionInterviewQuestionnaire AdministrationSurvey Administration
What this trial is about
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 inhibitor drugs. Patients will be asked their opinions about the design, accessibility, and content of the tool. Researchers will use the information collected to improve the educational materials that will help patients make future decisions about their treatment.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
3 locations listed across 1 US state.
- M D Anderson Cancer Center - Houston, Texas, United States
- M D Anderson Cancer Center - Houston, Texas, United States
- M D Anderson Cancer Center - Houston, Texas, United States