RECRUITING

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

Talk to us

Conditions

Ankylosing SpondylitisAutoimmune DiseaseCrohn DiseaseEnteropathic ArthritisEnteropathic SpondylitisInflammatory Bowel DiseaseMelanomaPsoriasisPsoriatic ArthritisReactive ArthritisRheumatoid ArthritisSystemic Lupus ErythematosusUlcerative Colitis

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-04-20
Study Completion:2025-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04751396

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of melanoma
  2. * Diagnosis of pre-existing autoimmune disease
  3. * Inflammatory bowel disease
  4. * Diagnosis of Crohn's disease or ulcerative colitis by a gastroenterologist
  5. * For ulcerative colitis, proof of chronic changes over time (i.e., 6 months) and signs of inflammation histologically
  6. * Treatment with aminosalicylates, corticosteroids, thiopurines, or immune modifiers (e.g., calcineurin inhibitors, methotrexate, adhesion molecule antagonists)
  7. * Rheumatoid arthritis
  8. * Diagnosis of rheumatoid arthritis by a rheumatologist
  9. * Treatment with traditional disease-modifying antirheumatic drugs (e.g., methotrexate, sulfasalazine, hydroxychloroquine) or targeted therapy
  10. * Systemic lupus erythematosus
  11. * Diagnosis of systemic lupus erythematosus by a rheumatologist
  12. * Psoriasis
  13. * Diagnosis of psoriasis by a dermatologist
  14. * 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
  15. * Spondyloarthropathies
  16. * Diagnosis of ankylosing spondylitis, reactive arthritis, psoriatic arthritis, or enteropathic arthritis/spondylitis by a rheumatologist
  17. * Treatment with disease-modifying antirheumatic drugs (e.g., sulfasalazine) or targeted therapy
  18. * Age of 18 years or older
  19. * 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
  20. * E-mail access and computer with Internet access or telephone
  21. * Ability to communicate in English or Spanish
  22. * CLINICIAN
  23. * Prescribed immune checkpoint inhibitors
  24. * Are providing care for patients with melanoma
  25. * In the clinics at MD Anderson
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Angeles Lopez-Olivo
CONTACT
713-792-9175
amlopezo@mdanderson.org

Principal Investigator

Angeles Lopez-Olivo
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Angeles Lopez-Olivo, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-20
Study Completion Date2025-04-15

Study Record Updates

Study Start Date2022-04-20
Study Completion Date2025-04-15

Terms related to this study

Additional Relevant MeSH Terms

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