Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
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- STATUS
- Recruiting
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- End date
- Apr 15, 2025
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- participants needed
- 125
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- sponsor
- M.D. Anderson Cancer Center
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 Identifier | NCT04751396 |
| Sponsor | M.D. Anderson Cancer Center |
| Last Modified on | 2 May 2022 |
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