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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Psoriasis; Crohn Disease; Ulcerative Colitis; Psoriatic Arthritis; Inflammatory Bowel Disease; Autoimmune Disease; Ankylosing Spondylitis; Reactive Arthritis; Enteropathic Arthritis; Enteropathic Spondylitis
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Other: Questionnaire Administration; Other: Educational Intervention; Other: Best Practice

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.

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Angeles Lopez-Olivo; Phone Number: 713-792-9175; Email: amlopezo@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Maria A. Lopez-Olivo; Phone Number: 713-792-9175
      • Principal Investigator: Maria A. Lopez-Olivo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with melanoma or pre-existing autoimmune disease and clinicians

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: Interview; Participate in interview; Other: Educational Intervention; Navigate educational tool; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
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: Survey Administration; Complete surveys; Other: Questionnaire Administration; Complete questionnaire; Other: Best Practice; Receive standard educational information; Other Names: standard of care; standard therapy
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: Survey Administration; Complete surveys; Other: Questionnaire Administration; Complete questionnaire; Other: Educational Intervention; Navigate educational tool; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge	Will be assessed using a questionnaire developed by the research team covering various content areas, including general information about immune checkpoint inhibitors and the associated adverse effects and benefits of the treatments.	Up to 3 months
Acceptability	A standard assessment questionnaire will be used to obtain users' ratings of various features of the educational tool, including ease of use, presentation, usefulness and satisfaction. The items in the questionnaire come from the Ottawa Acceptability Measures.	Immediately after the clinical encounter
Usability	A standard assessment questionnaire will be used to obtain users' ratings of various features of the educational tool, including ease of use, presentation, usefulness and satisfaction. The items in the questionnaire come from the Ottawa Acceptability Measures.	Immediately after the clinical encounter
Depression	Will be assessed using the Depression and Anxiety Stress Scale (DASS). The DASS is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia	Up to 3 months
Anxiety	Will be assessed using the DASS. The DASS is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. The Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect.	Up to 3 months
Stress	Will be assessed using the DASS. The DASS is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. The Stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient.	Up to 3 months
CollaboRATE measure	The CollaboRATE questions ask about the effort made to help patients understand their health issues, listen to what matters most to them, and include what matters most to them in choosing what to do next.	Immediately after the clinical encounter
Shared decision-making process survey	This instrument measures the extent to which health care providers engage patients in shared decision making. Items are focused on four specific behaviors that are critical for shared decision making -discussion of options, pros, cons and preferences.	Immediately after the clinical encounter
Patient's perception of usefulness of the tool	Will use the Preparation for Decision Making Scale (Prep-DM) to assess the patients' perception of how useful the educational tool is in preparing them to communicate with their practitioner at a consultation. It is a 10-item scale developed to evaluate decision processes relating to the preparation of patients for decision making and dialoguing with their practitioners.	Immediately after the clinical encounter

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Angeles Lopez-Olivo, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Estimated): April 15, 2025
• Study Completion (Estimated): April 15, 2025

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Skin Diseases; Infections; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Gastrointestinal Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Gastroenteritis; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Intestinal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Neuroendocrine Tumors; Nevi and Melanomas; Psoriasis; Bone Diseases, Infectious; Ankylosis; Arthritis, Infectious; Chronic Disease; Post-Infectious Disorders; Axial Spondyloarthritis; Arthritis; Lupus Erythematosus, Systemic; Inflammatory Bowel Diseases; Crohn Disease; Arthritis, Psoriatic; Melanoma; Autoimmune Diseases; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Arthritis, Reactive
• Other Study ID Numbers: 2020-0843 (Other Identifier: M D Anderson Cancer Center); NCI-2021-00565 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); K08CA237619 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No