Crohn'sUCRecruiting
Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
Observational · No treatment assigned · 1 site · M.D. Anderson Cancer Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ankylosing Spondylitis, Autoimmune Disease and Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Diagnosis of melanoma
- Diagnosis of pre-existing autoimmune disease
- Inflammatory bowel disease
Plus 22 more requirement(s). Only the trial team can confirm whether you qualify.
What's involved
- About 125 participants are expected to take part.
- Start date: 2022-04-20.
- Main results expected around 2027-02-02 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Decisional conflict scale (Up to 4 years)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| 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 |
| Lead sponsor | M.D. Anderson Cancer Center |
| Collaborators | National Cancer Institute (NCI) |
| Enrollment | 125 (estimated) |
| Start date | 2022-04-20 |
| Primary completion (est.) | 2027-02-02 |
| First posted | 2021-02-12 |
| Last updated | 2026-05-20 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT04751396 |
Interventions
- Best Practice (Other)
Receive standard educational information - Educational Intervention (Other)
Navigate educational tool - Interview (Other)
Participate in interview - Questionnaire Administration (Other)
Complete questionnaire - Survey Administration (Other)
Complete surveys
Full eligibility criteria (from the record)
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 AndersonLocations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center | Houston, Texas | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.