Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
NCT ID: NCT04751396
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
125 participants
OBSERVATIONAL
2022-04-20
2027-02-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Part A (Interview)
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.
Educational Intervention
Navigate educational tool
Interview
Participate in interview
Part B Group I (standard information)
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.
Best Practice
Receive standard educational information
Questionnaire Administration
Complete questionnaire
Survey Administration
Complete surveys
Part B Group II (educational tool)
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.
Educational Intervention
Navigate educational tool
Questionnaire Administration
Complete questionnaire
Survey Administration
Complete surveys
Interventions
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Best Practice
Receive standard educational information
Educational Intervention
Navigate educational tool
Interview
Participate in interview
Questionnaire Administration
Complete questionnaire
Survey Administration
Complete surveys
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Angeles Lopez-Olivo
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Maria A. Lopez-Olivo
Role: primary
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2021-00565
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-0843
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0843
Identifier Type: -
Identifier Source: org_study_id