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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

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

NCT number NCT04751396
Study type Observational
Source M.D. Anderson Cancer Center
Contact Angeles Lopez-Olivo
Phone 713-792-9175
Email amlopezo@mdanderson.org
Status Recruiting
Phase
Start date April 20, 2022
Completion date April 15, 2025

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