Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Testning av ett utbildningsverktyg för patienter med melanom och redan existerande autoimmuna sjukdomar som är kandidater för immunkontrollpunktshämmare

9 november 2026 uppdaterad av: M.D. Anderson Cancer Center

Testning av ett utbildningsverktyg för patienter med melanom och samtidig autoimmun sjukdom som är kandidater för adjuvant terapi med immunkontrollpunktshämmare: acceptans och användbarhet hos patienter och leverantörer

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

125

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • Rekrytering
        • M D Anderson Cancer Center
        • Kontakt:
          • Maria A. Lopez-Olivo
          • Telefonnummer: 713-792-9175
        • Huvudutredare:
          • Maria A. Lopez-Olivo

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients with melanoma or pre-existing autoimmune disease and clinicians

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Övrig: Interview

Participate in interview

Övrig: Educational Intervention

Navigate educational tool

Andra namn:
  • Utbildning för intervention
  • Intervention by Education
  • Intervention genom utbildning
  • Intervention, utbildning
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.
Övrig: Questionnaire Administration

Complete questionnaire

Övrig: Survey Administration

Complete surveys

Övrig: Best Practice

Receive standard educational information

Andra namn:
  • vårdstandard
  • standardterapi
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.
Övrig: Questionnaire Administration

Complete questionnaire

Övrig: Survey Administration

Complete surveys

Övrig: Educational Intervention

Navigate educational tool

Andra namn:
  • Utbildning för intervention
  • Intervention by Education
  • Intervention genom utbildning
  • Intervention, utbildning

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Decisional conflict scale
Tidsram: Up to 4 years

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Knowledge
Tidsram: Up to 3 months

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
Tidsram: Immediately after the clinical encounter

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
Tidsram: Immediately after the clinical encounter

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
Tidsram: Up to 3 months

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
Tidsram: Up to 3 months

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
Tidsram: Up to 3 months

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
Tidsram: Immediately after the clinical encounter

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
Tidsram: Immediately after the clinical encounter

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
Tidsram: Immediately after the clinical encounter

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

M.D. Anderson Cancer Center

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Angeles Lopez-Olivo, M.D. Anderson Cancer Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 april 2022

Primärt slutförande (Beräknad)

2 februari 2027

Avslutad studie (Beräknad)

2 februari 2027

Studieregistreringsdatum

Först inskickad

8 februari 2021

Först inskickad som uppfyllde QC-kriterierna

8 februari 2021

Första postat (Faktisk)

12 februari 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2020-0843
  • 2020-0843 (Annan identifierare: M D Anderson Cancer Center)
  • NCI-2021-00565 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • K08CA237619 (U.S.S. NIH-anslag/kontrakt)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera