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A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO) (VOLUME-PRO)

2. mai 2022 oppdatert av: Bristol-Myers Squibb

Nivolumab in the Real World in Patients With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)

The purpose of the study is to capture the utilization of nivolumab among participants with squamous cell carcinoma of the head and neck (SCCHN) since its approval, and to describe the health related quality of life (HRQoL) among participants treated with nivolumab in a real-world setting.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a phase 4 prospective chart review study with patient reported outcome (PRO) administration. The study population consists of participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) and are being treated with nivolumab. Eligible participants will be enrolled and observed from enrollment up to eight weeks. Demographic and clinical characteristics will be collected at enrollment. PROs will be administered at enrollment and again at a follow-up standard of care visit approximately eight weeks after enrollment.

Studietype

Observasjonsmessig

Registrering (Faktiske)

509

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • New Jersey
      • Mount Laurel, New Jersey, Forente stater, 08054
        • Local Institution

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

The population for this study will be approximately 50 adult participants, with a diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) currently being treated with nivolumab in the United Kingdom, Switzerland, Spain, or Canada. The study population will include participants with available data from medical records at enrollment who are willing to complete patient reported outcome (PRO) assessments.

Beskrivelse

Inclusion Criteria:

  • Diagnosis of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN)
  • Age ≥18 years at time of nivolumab treatment initiation
  • Investigator has decided that nivolumab is appropriate therapy and the participant had received at least one administration of nivolumab for the treatment of recurrent/metastatic SCCHN prior to enrolment in the study
  • Charts/records include treatment start date of nivolumab
  • Provide consent and is willing to self-complete on-site patient reported outcomes (PROs) on at least one occasion

Exclusion Criteria:

  • Currently enrolled in an interventional clinical trial for their SCCHN
  • Received systemic treatment for any other primary cancer within 6 months of study enrolment

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
Cohort 1
Participants with squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab
Biologisk: Nivolumab
Participants in this study are being treated with nivolumab for SCCHN
Andre navn:
  • Opdivo®, BMS-936558

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth
Tidsramme: At enrollment
Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head & Neck (SCCHN)
At enrollment
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Sex
Tidsramme: At enrollment
At enrollment
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Race/ethnicity
Tidsramme: At enrollment
At enrollment
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Smoking status
Tidsramme: At enrollment
At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Primary tumor location
Tidsramme: At enrollment
At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Metastasis locations
Tidsramme: At enrollment
At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Histology
Tidsramme: At enrollment
At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Date of diagnosis of R/M SCCHN
Tidsramme: At enrollment
At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Stage at locally advanced/metastatic SCCHN diagnosis
Tidsramme: At enrollment
At enrollment
Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Duration of nivolumab therapy
Tidsramme: Up to 8 weeks following enrollment
Up to 8 weeks following enrollment
Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Drug discontinuation
Tidsramme: Up to 8 weeks following enrollment
Up to 8 weeks following enrollment
Distribution of doses of nivolumab therapy in participants with R/M SCCHN
Tidsramme: Up to 8 weeks following enrollment
Up to 8 weeks following enrollment
Distribution of subsequent treatment in participants discontinuing nivolumab
Tidsramme: Up to 8 weeks following enrollment
Up to 8 weeks following enrollment
Distribution of patient reported health-related quality of life (HRQoL) measures through European Organisation for Research and Treatment of Cancer Quality of Life- Core Questionnaire in participants treated with nivolumab for R/M SCCHN
Tidsramme: At enrollment, Up to 8 weeks
At enrollment, Up to 8 weeks
Distribution of patient reported HRQoL measures through EQ-5D-5L in participants treated with nivolumab for R/M SCCHN
Tidsramme: At enrollment, Up to 8 weeks
At enrollment, Up to 8 weeks
Distribution of patient reported HRQoL measures through European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module in participants treated with nivolumab for R/M SCCHN
Tidsramme: At enrollment, Up to 8 weeks
At enrollment, Up to 8 weeks
Distribution of patient reported HRQoL measures through CTSQ in participants treated with nivolumab for R/M SCCHN
Tidsramme: At enrollment, Up to 8 weeks
Cancer Therapy Satisfaction Questionnaire (CTSQ)
At enrollment, Up to 8 weeks
Distribution of patient reported HRQoL measures through WPAI:GH in participants treated with nivolumab for R/M SCCHN
Tidsramme: At enrollment, Up to 8 weeks
Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)
At enrollment, Up to 8 weeks

Samarbeidspartnere og etterforskere

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

Sponsor

Bristol-Myers Squibb

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)

13. august 2020

Primær fullføring (Faktiske)

18. oktober 2021

Studiet fullført (Faktiske)

18. oktober 2021

Datoer for studieregistrering

Først innsendt

8. september 2021

Først innsendt som oppfylte QC-kriteriene

24. september 2021

Først lagt ut (Faktiske)

6. oktober 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mai 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. mai 2022

Sist bekreftet

1. mai 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CA209-7F9

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