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

  • STATUS
    Recruiting
  • End date
    Apr 15, 2025
  • participants needed
    125
  • sponsor
    M.D. Anderson Cancer Center
Updated on 2 May 2022
corticosteroids
cyclosporine
methotrexate
retinoids
psoriasis
ulcerative colitis
hydroxychloroquine
inflammatory bowel disease
targeted therapy
autoimmune disease
vitamin
phototherapy
arthritis
crohn's disease
enteropathy
DMARD
sulfasalazine
anti-rheumatic drugs
spondyloarthropathies
colitis
lupus
rheumatoid arthritis
topical agents
spondylitis
psoriatic arthritis
ulceration
thiopurines
aminosalicylate
calcineurin inhibitors
puva
ankylosing spondylitis
antirheumatics
aminosalicylates

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.

Description

PRIMARY OBJECTIVES:

I. To evaluate the acceptability (e.g., ease of use, design, accessibility, content) of the educational tool that will be developed for patients with melanoma and pre-existing autoimmune conditions considering or undergoing treatment with immune checkpoint inhibitors.

II. To test the usability in real world-settings of the educational tool (to be developed) and evaluate feasibility of patient recruitment (i.e., ability to identify enough patients and consent at least 50% of the identified patients) in a pilot study.

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.

PART B: 2 group of participants will be evaluated sequentially (Participants in group II will be enrolled after all the participants in group I have been assessed).

GROUP I: Patients receive standard educational information during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months.

GROUP II: Patients navigate educational tool over 20 minutes during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months.

Details
Condition 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
Treatment questionnaire administration, educational intervention, Interview, survey administration, Best Practice
Clinical Study IdentifierNCT04751396
SponsorM.D. Anderson Cancer Center
Last Modified on2 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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