Educational tool for melanoma patients with autoimmune diseases
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
This study is testing a new educational tool to help melanoma patients with autoimmune diseases understand their treatment options better and see how easy it is for them to use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04751396 on ClinicalTrials.gov |
What this trial studies
This study evaluates an educational tool designed for patients with melanoma and pre-existing autoimmune diseases who are candidates for immune checkpoint inhibitors. Participants will navigate the tool and provide feedback on its usability, design, and content. The study aims to assess the acceptability of the tool and its feasibility in real-world settings, including patient recruitment and consent rates. Data collected will be used to enhance educational materials that assist patients in making informed treatment decisions.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with melanoma and a pre-existing autoimmune disease such as rheumatoid arthritis, Crohn's disease, or systemic lupus erythematosus.
Not a fit: Patients without a diagnosis of melanoma or those without any pre-existing autoimmune conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve patient understanding and decision-making regarding their treatment options.
How similar studies have performed: Other studies have shown success in using educational tools to enhance patient understanding and engagement, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Angeles Lopez-Olivo — M.D. Anderson Cancer Center
- Study coordinator: Angeles Lopez-Olivo
- Email: amlopezo@mdanderson.org
- Phone: 713-792-9175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.