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

NCT04751396 | Recruiting

• 3 other identifiers: 2020-0843NCI-2021-00565K08CA237619
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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; Inflammatory Bowel Disease; Melanoma; Psoriasis; Psoriatic Arthritis; Reactive Arthritis; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Decisional conflict scale

  The scale will be used to assess personal perceptions of 1) uncertainty in choosing among options; 2) modifiable factors contributing to uncertainty, such as feeling uninformed, and 3) feeling that the choice is values-based and likely to be implemented.

  Up to 4 years

Secondary Outcomes (9)

• Knowledge

  Up to 3 months

• Acceptability

  Immediately after the clinical encounter

• Usability

  Immediately after the clinical encounter

• Depression

  Up to 3 months

• Anxiety

  Up to 3 months

Study Arms (3)

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.

Other: Educational Intervention; Other: 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.

Other: Best Practice; Other: Questionnaire Administration; Other: Survey Administration

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.

Other: Educational Intervention; Other: Questionnaire Administration; Other: Survey Administration

Interventions

Best Practice OTHER

Receive standard educational information

Also known as: standard of care, standard therapy

Part B Group I (standard information)

Educational Intervention OTHER

Navigate educational tool

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Part A (Interview); Part B Group II (educational tool)

Interview OTHER

Participate in interview

Part A (Interview)

Questionnaire Administration OTHER

Complete questionnaire

Part B Group I (standard information); Part B Group II (educational tool)

Survey Administration OTHER

Complete surveys

Part B Group I (standard information); Part B Group II (educational tool)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with melanoma or pre-existing autoimmune disease and clinicians

You may qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Spondylitis, Ankylosing; Autoimmune Diseases; Crohn Disease; Inflammatory Bowel Diseases; Melanoma; Psoriasis; Arthritis, Psoriatic; Arthritis, Reactive; Arthritis, Rheumatoid; Lupus Erythematosus, Systemic; Colitis, Ulcerative

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods; Interviews as Topic

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Papulosquamous; Arthritis, Infectious; Infections; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rheumatic Diseases; Connective Tissue Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Angeles Lopez-Olivo

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angeles Lopez-Olivo

CONTACT

713-792-9175; amlopezo@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 12, 2021
• Study Start: April 20, 2022
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)