Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
125
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how well patients with melanoma and pre-existing autoimmune diseases can use a new educational tool designed to help them understand treatment with immune checkpoint inhibitors. This study aims to gather patient opinions on the tool's design, ease of use, accessibility, and content to improve educational materials that support future treatment decisions. The study also tests how feasible it is to recruit patients for the study and use the tool in real-world settings. The study has two parts. In Part A, participants will spend 30 to 45 minutes using the educational tool and then take part in a 45-minute interview to share their thoughts about the tool's content and format. Part B involves two groups: Group I receives standard educational information during their clinical visit and completes questionnaires at baseline, immediately after the visit, and three months later. Group II uses the educational tool for about 20 minutes during their clinical visit and completes the same questionnaires over the same timeframes. Participants will complete interviews or questionnaires to assess their knowledge, decision-making confidence, and feelings such as anxiety, depression, and stress. Researchers will also evaluate the tool's acceptability, usability, and how patients perceive its usefulness. These assessments occur immediately after the clinical encounter and up to three months afterward. The study plans to follow key outcomes like decisional conflict for up to four years. Overall, participants will be involved in scheduled visits and surveys over several months to help improve patient education in melanoma treatment.
CONDITIONS
Brief Title
Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of melanoma
- Diagnosis of pre-existing autoimmune disease such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, systemic lupus erythematosus, psoriasis, ankylosing spondylitis, reactive arthritis, psoriatic arthritis, or enteropathic arthritis
- Age 18 years or older
- Physician recommendation to begin or decision made regarding immune checkpoint inhibitor treatment
- Access to email and a computer with internet or telephone
- Ability to communicate in English or Spanish
- Receiving care for melanoma at MD Anderson clinics
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - Approximately 2 hours in total
Participants navigate the educational tool over 30-45 minutes and then participate in an interview about their thoughts and opinions on the content, ease of use, and format of the tool over 45 minutes.
1 visit (in-person or remote)
Duration - 3 months
Participants receive standard educational information during their clinician encounter and complete questionnaires at baseline, immediately after the encounter, and at 3 months to assess knowledge, acceptability, usability, and emotional outcomes.
3 visits: 1 baseline visit within a week prior to clinician encounter, 1 clinician encounter visit, and 1 follow-up visit at 3 months
Duration - 3 months
Participants navigate the educational tool over about 20 minutes during their clinician encounter and complete questionnaires at baseline, immediately after the encounter, and at 3 months to assess knowledge, acceptability, usability, and emotional outcomes.
3 visits: 1 baseline visit within a week prior to clinician encounter, 1 clinician encounter visit, and 1 follow-up visit at 3 months
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Angeles Lopez-Olivo
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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