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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04751396
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Best Practice — OTHER
    Receive standard educational information
  • Educational Intervention — OTHER
    Navigate educational tool
  • Interview — OTHER
    Participate in interview
  • Questionnaire Administration — OTHER
    Complete questionnaire
  • Survey Administration — OTHER
    Complete surveys

Study Details

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.

Key Dates

Start date
Apr 20, 2022
Status verified
May 2026
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

Enrollment
125 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Decisional conflict scale [ Time Frame: Up to 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Maria A. Lopez-Olivo
713-792-9175
Maria A. Lopez-Olivo (PRINCIPAL_INVESTIGATOR)

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