NCT04751396

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 125 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

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

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard educational information
OTHER	Educational Intervention	Navigate educational tool
OTHER	Interview	Participate in interview
OTHER	Questionnaire Administration	Complete questionnaire
OTHER	Survey Administration	Complete surveys

Timeline

• Start date: 2022-04-20
• Primary completion: 2027-02-02
• Completion: 2027-02-02
• First posted: 2021-02-12
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States