Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "OUTLINE: PART A: Participants navigate the educational tool over 30-45 minutes then participate in an interview about their thoughts and opinions about the content, ease of use, and format of the tool over 45 minutes."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how easy an educational tool is to use for people with melanoma, a type of skin cancer, and an autoimmune disease, where the immune system attacks the body. It is for people considering or receiving immune checkpoint inhibitors, drugs that help the immune system fight cancer. Patients will share feedback to help improve the tool for future treatment choices.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Patients must be age 18 or older and have melanoma.
- Patients must have an existing autoimmune disease listed below. For Crohn’s disease or ulcerative colitis, a gut specialist must confirm the diagnosis, and treatment with certain medicines is required. Ulcerative colitis also needs proof of lasting changes over 6 months and inflammation in tissue samples.
- For rheumatoid arthritis or certain types of spine or joint arthritis, a joint disease specialist must confirm the diagnosis. Treatment with medicines that slow the disease or target the immune system is required.
- For lupus, a disease where the immune system attacks the body, a joint disease specialist must confirm the diagnosis.
- For psoriasis, a disease that causes patches of inflamed skin, a skin specialist must confirm the diagnosis. Treatment with skin products, light therapy, or certain medicines is required.
- A doctor must have recommended an immune checkpoint inhibitor, or the patient must be deciding or have decided whether to start one.
- Patients must have email access and either a computer with internet or a telephone. They must be able to communicate in English or Spanish.
- Clinicians may take part if they have prescribed immune checkpoint inhibitors and care for patients with melanoma in MD Anderson clinics.
Who can't join
Simplified for readability. The official criteria below are what the study team uses.
Official 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 sites (1)
TX
- M D Anderson Cancer Center · Houston, TX 77030Maria A. Lopez-Olivo · Study contact · 713-792-9175Maria A. Lopez-Olivo · Principal investigatorMore trials in Houston