- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02565017
Examining Patient Preferences About the IBM Watson Oncology Clinical Decision Support System
23. juni 2020 oppdatert av: Memorial Sloan Kettering Cancer Center
The purpose of this study is to learn what cancer patients think about IBM Watson Oncology.
IBM Watson Oncology is a computer program designed to help inform oncologists about the best chemotherapy choices for their patients.
The investigators will conduct focus groups with cancer patients who have received chemotherapy treatment at MSK in order to understand cancer patients' thoughts about IBM Watson Oncology.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
70
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10065
- Memorial Sloan Kettering Cancer Center
-
-
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
MSKCC clinics
Beskrivelse
Inclusion Criteria:
- MSKCC patient 18 years or older
Breast, lung, or colorectal cancer MSK patient as per EMR or clinician judgment having either:
- Chemotherapeutic adjuvant or neoadjuvant treatment with the first chemo visit occurring within the past 8 months and primary treatment (i.e., surgery), occurring within the past 6 months)at MSK
- OR chemotherapeutic treatment for metastatic disease with the first chemo visit occurring within the past 8 months at MSK
- OR chemotherapeutic treatment through an on-going MSK clinical trial as per clinician
- Residing in New York metro-area
Exclusion Criteria:
- Non-English speakers because we do not have the resources to conduct and translate the focus groups into other languages
- Patients who are not or will not receive their cancer care at MSKCC.
- Patient unwilling or unable to provide informed consent
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Breast Cancer
and treatment type (chemotherapeutic adjuvant (i.e., chemotherapy delivered after primary therapy/surgery) or neoadjuvant (i.e., chemotherapy delivered prior to primary therapy/surgery) treatment, chemotherapeutic treatment for metastatic disease, or chemotherapeutic treatment through a clinical trial).
|
After the presentation of the of IBM Watson Oncology at the opening of the focus group, participants will be asked to fill out a de-identified brief 15-item questionnaire to assess participants' first impressions of IBM Watson Oncology.
The questionnaire will be self administered, and will take approximately 5 minutes to complete.
Completed questionnaires will be collected by a member of the study staff, and the focus group will proceed with introductions.
The focus group will be audio recorded from the completion of the introductions and notes will be taken.
The focus group guide will address the study aims.
At the end of the focus group, participants will complete a 7-item questionnaire to capture simple demographic information including education, income, and health literacy.
This questionnaire will take 3-5 minutes to complete.
|
|
Lung Cancer
and treatment type (chemotherapeutic adjuvant (i.e., chemotherapy delivered after primary therapy/surgery) or neoadjuvant (i.e., chemotherapy delivered prior to primary therapy/surgery) treatment, chemotherapeutic treatment for metastatic disease, or chemotherapeutic treatment through a clinical trial).
|
After the presentation of the of IBM Watson Oncology at the opening of the focus group, participants will be asked to fill out a de-identified brief 15-item questionnaire to assess participants' first impressions of IBM Watson Oncology.
The questionnaire will be self administered, and will take approximately 5 minutes to complete.
Completed questionnaires will be collected by a member of the study staff, and the focus group will proceed with introductions.
The focus group will be audio recorded from the completion of the introductions and notes will be taken.
The focus group guide will address the study aims.
At the end of the focus group, participants will complete a 7-item questionnaire to capture simple demographic information including education, income, and health literacy.
This questionnaire will take 3-5 minutes to complete.
|
|
Colorectal Cancer
and treatment type (chemotherapeutic adjuvant (i.e., chemotherapy delivered after primary therapy/surgery) or neoadjuvant (i.e., chemotherapy delivered prior to primary therapy/surgery) treatment, chemotherapeutic treatment for metastatic disease, or chemotherapeutic treatment through a clinical trial).
|
After the presentation of the of IBM Watson Oncology at the opening of the focus group, participants will be asked to fill out a de-identified brief 15-item questionnaire to assess participants' first impressions of IBM Watson Oncology.
The questionnaire will be self administered, and will take approximately 5 minutes to complete.
Completed questionnaires will be collected by a member of the study staff, and the focus group will proceed with introductions.
The focus group will be audio recorded from the completion of the introductions and notes will be taken.
The focus group guide will address the study aims.
At the end of the focus group, participants will complete a 7-item questionnaire to capture simple demographic information including education, income, and health literacy.
This questionnaire will take 3-5 minutes to complete.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Acceptability of IBM Watson Oncology
Tidsramme: 1 year
|
Data collected through the brief questionnaires (e.g.,initial impressions of IBM Watson Oncology, sociodemographics) will be entered into an SPSS data file on the secure MSK server.
|
1 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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)
15. september 2015
Primær fullføring (Faktiske)
22. juni 2020
Studiet fullført (Faktiske)
22. juni 2020
Datoer for studieregistrering
Først innsendt
30. september 2015
Først innsendt som oppfylte QC-kriteriene
30. september 2015
Først lagt ut (Anslag)
1. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. juni 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juni 2020
Sist bekreftet
1. august 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 15-226
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .