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Educational Tool for Melanoma Patients with Autoimmune Disease Considering Immune Checkpoint Inhibitors

This study is testing an educational tool designed for people with melanoma and an existing autoimmune disease (like Crohn's disease or ankylosing spondylitis) who are considering or receiving immune checkpoint inhibitors. These drugs help your immune system fight cancer. Researchers want to learn how easy the tool is to use, its design, and its content. Your feedback will help improve these educational materials, which aim to help patients make informed decisions about their treatment. To join, you must have a melanoma diagnosis and a pre-existing autoimmune disease. The study will be considered successful if the educational tool is acceptable and usable, and if enough patients can be recruited.

Study design
This is an observational study with a planned enrollment of 125 participants. It involves two parts, with some participants navigating the educational tool and others receiving standard information.
What's involved
You would navigate an educational tool for 20-45 minutes and participate in interviews or complete questionnaires. Some participants will also complete questionnaires at baseline, immediately after a clinician encounter, and at 3 months.
Compensation
Not stated in the trial record.
Follow-up
Some participants will complete questionnaires up to 3 months after their clinician encounter. The primary endpoint, decisional conflict, is measured up to 4 years.

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NCT04751396

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

Recruiting
Not specifiedAges 18+Observational
M.D. Anderson Cancer Center
~125 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Best PracticeEducational InterventionInterviewQuestionnaire AdministrationSurvey Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Decisional conflict scale
Measured over Up to 4 years

Conditions

Ankylosing Spondylitis
Autoimmune Disease
Crohn Disease
Enteropathic Arthritis
Enteropathic Spondylitis
Inflammatory Bowel Disease
Melanoma
Psoriasis
Psoriatic Arthritis
Reactive Arthritis
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Ulcerative Colitis

Explore related trials

Ankylosing SpondylitisCrohn DiseaseEnteropathic ArthritisEnteropathic SpondylitisMelanomaPsoriasisPsoriatic ArthritisReactive ArthritisRheumatoid ArthritisSystemic Lupus ErythematosusUlcerative Colitis

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Angeles Lopez-Olivo · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Angeles Lopez-Olivo
[email protected]
713-792-9175
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Decisional conflict scaleUp to 4 years

    The scale will be used to assess personal perceptions of 1) uncertainty in choosing among options; 2) modifiable factors contributing to uncertainty, such as feeling uninformed, and 3) feeling that the choice is values-based and likely to be implemented.