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Testing av et pedagogisk verktøy for pasienter med melanom og allerede eksisterende autoimmun sykdom som er kandidater for immunsjekkpunkthemmere

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

Testing av et pedagogisk verktøy for pasienter med melanom og samtidig autoimmun sykdom som er kandidater for adjuvant terapi med immunsjekkpunkthemmere: Akseptabilitet og brukervennlighet hos pasienter og leverandører

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

125

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • M D Anderson Cancer Center
        • Ta kontakt med:
          • Maria A. Lopez-Olivo
          • Telefonnummer: 713-792-9175
        • Hovedetterforsker:
          • Maria A. Lopez-Olivo

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with melanoma or pre-existing autoimmune disease and clinicians

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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.
Annen: Interview

Participate in interview

Annen: Educational Intervention

Navigate educational tool

Andre navn:
  • Utdanning for intervensjon
  • Intervensjon fra utdanning
  • Intervensjon gjennom utdanning
  • Intervensjon, pedagogisk
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.
Annen: Questionnaire Administration

Complete questionnaire

Annen: Survey Administration

Complete surveys

Annen: Best Practice

Receive standard educational information

Andre navn:
  • velferdstandard
  • standard terapi
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.
Annen: Questionnaire Administration

Complete questionnaire

Annen: Survey Administration

Complete surveys

Annen: Educational Intervention

Navigate educational tool

Andre navn:
  • Utdanning for intervensjon
  • Intervensjon fra utdanning
  • Intervensjon gjennom utdanning
  • Intervensjon, pedagogisk

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Decisional conflict scale
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Knowledge
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

M.D. Anderson Cancer Center

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. april 2022

Primær fullføring (Antatt)

2. februar 2027

Studiet fullført (Antatt)

2. februar 2027

Datoer for studieregistrering

Først innsendt

8. februar 2021

Først innsendt som oppfylte QC-kriteriene

8. februar 2021

Først lagt ut (Faktiske)

12. februar 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2020-0843
  • 2020-0843 (Annen identifikator: M D Anderson Cancer Center)
  • NCI-2021-00565 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • K08CA237619 (U.S. NIH-stipend/kontrakt)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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