Health TrialsbyHealthPanel

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

ConditionsAnkylosing SpondylitisAutoimmune DiseaseCrohn DiseaseEnteropathic ArthritisEnteropathic SpondylitisInflammatory Bowel DiseaseMelanomaPsoriasisPsoriatic ArthritisReactive ArthritisRheumatoid ArthritisSystemic Lupus ErythematosusUlcerative Colitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of melanoma

Diagnosis of pre-existing autoimmune disease

Inflammatory bowel disease

Diagnosis of Crohn's disease or ulcerative colitis by a gastroenterologist

Disqualifiers

None

Trial population

Patients with melanoma or pre-existing autoimmune disease and clinicians

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Best Practice

    Other intervention

    Receive standard educational information

  • Educational Intervention

    Other intervention

    Navigate educational tool

  • Interview

    Other intervention

    Participate in interview

  • Questionnaire Administration

    Other intervention

    Complete questionnaire

  • Survey Administration

    Other intervention

    Complete surveys

Treatment groups

125 Participants
are divided into 3 treatment groups
Group A: Part A (Interview)2 interventions
Group B: Part B Group I (standard information)3 interventions
Group C: Part B Group II (educational tool)3 interventions

Trial outcomes

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.

Time frame
Up to 4 years

Secondary outcomes

1

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.

Time frame
Up to 3 months
2

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.

Time frame
Immediately after the clinical encounter
3

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.

Time frame
Immediately after the clinical encounter
4

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

Time frame
Up to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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