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

Official title

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

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.

Interventions

• 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

Primary outcome measures

• Decisional conflict scale [Time frame: Up to 4 years]

Secondary outcome measures (9)

• Knowledge [Time frame: Up to 3 months]
• Acceptability [Time frame: Immediately after the clinical encounter]
• Usability [Time frame: Immediately after the clinical encounter]
• Depression [Time frame: Up to 3 months]
• Anxiety [Time frame: Up to 3 months]
• Stress [Time frame: Up to 3 months]
• CollaboRATE measure [Time frame: Immediately after the clinical encounter]
• Shared decision-making process survey [Time frame: Immediately after the clinical encounter]
• Patient's perception of usefulness of the tool [Time frame: Immediately after the clinical encounter]

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

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT04751396 · 2020-0843 · NCI-2021-00565 · 2020-0843 · K08CA237619

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗