Clinical trial NCT04751396: Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-02-12
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with melanoma or pre-existing autoimmune disease and clinicians

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.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the acceptability (e.g., ease of use, design, accessibility, content) of the educational tool that will be developed for patients with melanoma and pre-existing autoimmune conditions considering or undergoing treatment with immune checkpoint inhibitors.

II. To test the usability in real world-settings of the educational tool (to be developed) and evaluate feasibility of patient recruitment (i.e., ability to identify enough patients and consent at least 50% of the identified patients) in a pilot study.

OUTLINE:

PART A: 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: 2 group of participants will be evaluated sequentially (Participants in group II will be enrolled after all the participants in group I have been assessed).

GROUP I: 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.

GROUP II: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Decisional conflict scale
timeFrame: Up to 4 years
Secondary outcomes:
measure: Knowledge
timeFrame: Up to 3 months
measure: Acceptability
timeFrame: Immediately after the clinical encounter
measure: Usability
timeFrame: Immediately after the clinical encounter
measure: Depression
timeFrame: Up to 3 months
measure: Anxiety
timeFrame: Up to 3 months
measure: Stress
timeFrame: Up to 3 months
measure: CollaboRATE measure
timeFrame: Immediately after the clinical encounter
measure: Shared decision-making process survey
timeFrame: Immediately after the clinical encounter
measure: Patient's perception of usefulness of the tool
timeFrame: Immediately after the clinical encounter
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Angeles Lopez-Olivo
role: PRINCIPAL_INVESTIGATOR
References: