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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Other: Best Practice
* Other: Educational Intervention
* Other: Interview
* Other: Questionnaire Administration
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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 Diagnosis of systemic lupus erythematosus by a rheumatologist Psoriasis Diagnosis of psoriasis by a dermatologist Treatment with corticosteroids, vitamin D analogs, anthralin, topical retinoids, calcineurin inhibitors, salicylic acid, coal tar, or moisturizers; light therapy, including sunlight, ultraviolet B (UVB) phototherapy, narrowband UVB therapy, Goeckerman therapy, photochemotherapy, excimer laser, or pulsed dye laser; or systemic medications, including retinoids, methotrexate, cyclosporine, hydroxyurea, or thioguanine or targeted therapies Spondyloarthropathies Diagnosis of ankylosing spondylitis, reactive arthritis, psoriatic arthritis, or enteropathic arthritis/spondylitis by a rheumatologist Treatment with disease-modifying antirheumatic drugs (e.g., sulfasalazine) or targeted therapy Age of 18 years or older Patients whose physicians had recommended they begin using any of the currently available immune checkpoint inhibitors or people who are in the midst of or have already made the decision on whether or not start an immune checkpoint inhibitor E-mail access and computer with Internet access or telephone Ability to communicate in English or Spanish CLINICIAN Prescribed immune checkpoint inhibitors Are providing care for patients with melanoma In the clinics at MD Anderson

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Part A (Interview)<br>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. | Other: Educational Intervention<br>* Navigate educational tool<br>* Other names: Intervention, Educational;Other: Interview<br>* Participate in interview<br>|
| Part B Group I (standard information)<br>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. | Other: Best Practice<br>* Receive standard educational information<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Complete questionnaire<br>Other: Survey Administration<br>* Complete surveys<br>|
| Part B Group II (educational tool)<br>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. | Other: Educational Intervention<br>* Navigate educational tool<br>* Other names: Intervention, Educational;Other: Questionnaire Administration<br>* Complete questionnaire<br>Other: Survey Administration<br>* Complete surveys<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict scale | 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. | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge | Will be assessed using a questionnaire developed by the research team covering various content areas, including general information about immune checkpoint inhibitors and the associated adverse effects and benefits of the treatments. | Up to 3 months | 
| Acceptability | A standard assessment questionnaire will be used to obtain users' ratings of various features of the educational tool, including ease of use, presentation, usefulness and satisfaction. The items in the questionnaire come from the Ottawa Acceptability Measures. | Immediately after the clinical encounter | 
| Usability | A standard assessment questionnaire will be used to obtain users' ratings of various features of the educational tool, including ease of use, presentation, usefulness and satisfaction. The items in the questionnaire come from the Ottawa Acceptability Measures. | Immediately after the clinical encounter | 
| Depression | Will be assessed using the Depression and Anxiety Stress Scale (DASS). The DASS is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia | Up to 3 months | 
| Anxiety | Will be assessed using the DASS. The DASS is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. The Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. | Up to 3 months | 
| Stress | Will be assessed using the DASS. The DASS is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. The Stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. | Up to 3 months | 
| CollaboRATE measure | The CollaboRATE questions ask about the effort made to help patients understand their health issues, listen to what matters most to them, and include what matters most to them in choosing what to do next. | Immediately after the clinical encounter | 
| Shared decision-making process survey | This instrument measures the extent to which health care providers engage patients in shared decision making. Items are focused on four specific behaviors that are critical for shared decision making -discussion of options, pros, cons and preferences. | Immediately after the clinical encounter | 
| Patient's perception of usefulness of the tool | Will use the Preparation for Decision Making Scale (Prep-DM) to assess the patients' perception of how useful the educational tool is in preparing them to communicate with their practitioner at a consultation. It is a 10-item scale developed to evaluate decision processes relating to the preparation of patients for decision making and dialoguing with their practitioners. | Immediately after the clinical encounter |