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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ankylosing Spondylitis
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Decisional conflict scale
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Decisional conflict scale
Time Frame: Up to 4 years
The scale will be used to assess personal perceptions of 1) uncertainty in choosing among options; 2) modifiable factors contributing to uncertainty, such as feeling uninformed, and 3) feeling that the choice is values-based and likely to be implemented.
Secondary Outcomes
- Patient's perception of usefulness of the tool(Immediately after the clinical encounter)
- Knowledge(Up to 3 months)
- Usability(Immediately after the clinical encounter)
- Anxiety(Up to 3 months)
- Stress(Up to 3 months)
- CollaboRATE measure(Immediately after the clinical encounter)
- Shared decision-making process survey(Immediately after the clinical encounter)
- Acceptability(Immediately after the clinical encounter)
- Depression(Up to 3 months)