RecruitingNot Applicable

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

United States125 participantsStarted 2022-04-20

Plain-language 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 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 participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 rheumato…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is testing an educational tool rather than a new drug or procedure, what exactly would I be doing as a participant — and how might it help me make a better decision about whether immune checkpoint inhibitors are right for me given my autoimmune condition?
2Because I have both melanoma and a pre-existing autoimmune disease like mine, how does my doctor weigh the risk that immune checkpoint inhibitors could trigger a serious flare of my autoimmune condition against the potential benefit for my melanoma?
3This study is measuring 'decisional conflict' — meaning how torn or uncertain patients feel about their treatment choices — so would participating actually change the treatment I receive, or is it purely about helping me feel more informed and confident in the decision I'm already facing?
4Given that this is a Phase NA educational study and not a drug trial, would my doctor still recommend I go through standard counseling about immune checkpoint inhibitor risks regardless of whether I join, so I'm not relying solely on this study's tool for that information?
5Are there specific autoimmune conditions on this trial's list — like lupus or inflammatory bowel disease — where my doctor thinks the risks of immune checkpoint inhibitors are especially high, and how would that affect whether this educational tool would even be relevant to my situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Decisional conflict scale

Timeframe: Up to 4 years

Trial details

NCT IDNCT04751396

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-02-02

Contact for this trial

Angeles Lopez-Olivo

713-792-9175 amlopezo@mdanderson.org

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