Recruiting

Immune Checkpoint Inhibitors

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04751396

Conditions

Ankylosing Spondylitis

Autoimmune Disease

Crohn Disease

Enteropathic Arthritis

Enteropathic Spondylitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Educational Intervention

Interview

Questionnaire Administration

Survey Administration

Study Details

Brief summary:

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.

Conditions

Ankylosing Spondylitis

Autoimmune Disease

Crohn Disease

Enteropathic Arthritis

Enteropathic Spondylitis

Study ID

NCT04751396

Start date

Apr 20, 2022

Status verified date

May, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

Best Practice

Receive standard educational information

Educational Intervention

Navigate educational tool

Interview

Participate in interview

Questionnaire Administration

Complete questionnaire

Survey Administration

Complete surveys

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Angeles Lopez-Olivo

713-792-9175amlopezo@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Maria A. Lopez-Olivo

713-792-9175

Principal Investigator:

Maria A. Lopez-Olivo

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-12. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.