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
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- OtherBest Practice
Receive standard educational information
- OtherEducational Intervention
Navigate educational tool
- OtherInterview
Participate in interview
- OtherQuestionnaire Administration
Complete questionnaire
- OtherSurvey Administration
Complete surveys
Location
- M D Anderson Cancer CenterHouston, Texas