A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO) (VOLUME-PRO)
2 mei 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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
Observationeel
Inschrijving (Werkelijk)
509
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New Jersey
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Mount Laurel, New Jersey, Verenigde Staten, 08054
- Local Institution
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Cohort 1
Participants with squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab
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Participants in this study are being treated with nivolumab for SCCHN
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth
Tijdsspanne: At enrollment
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Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head & Neck (SCCHN)
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At enrollment
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Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Sex
Tijdsspanne: At enrollment
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At enrollment
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Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Race/ethnicity
Tijdsspanne: At enrollment
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At enrollment
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Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Smoking status
Tijdsspanne: At enrollment
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At enrollment
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Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Primary tumor location
Tijdsspanne: At enrollment
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At enrollment
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Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Metastasis locations
Tijdsspanne: At enrollment
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At enrollment
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Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Histology
Tijdsspanne: At enrollment
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At enrollment
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Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Date of diagnosis of R/M SCCHN
Tijdsspanne: At enrollment
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At enrollment
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Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Stage at locally advanced/metastatic SCCHN diagnosis
Tijdsspanne: At enrollment
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At enrollment
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Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Duration of nivolumab therapy
Tijdsspanne: Up to 8 weeks following enrollment
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Up to 8 weeks following enrollment
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Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Drug discontinuation
Tijdsspanne: Up to 8 weeks following enrollment
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Up to 8 weeks following enrollment
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Distribution of doses of nivolumab therapy in participants with R/M SCCHN
Tijdsspanne: Up to 8 weeks following enrollment
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Up to 8 weeks following enrollment
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Distribution of subsequent treatment in participants discontinuing nivolumab
Tijdsspanne: Up to 8 weeks following enrollment
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Up to 8 weeks following enrollment
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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
Tijdsspanne: At enrollment, Up to 8 weeks
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At enrollment, Up to 8 weeks
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Distribution of patient reported HRQoL measures through EQ-5D-5L in participants treated with nivolumab for R/M SCCHN
Tijdsspanne: At enrollment, Up to 8 weeks
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At enrollment, Up to 8 weeks
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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
Tijdsspanne: At enrollment, Up to 8 weeks
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At enrollment, Up to 8 weeks
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Distribution of patient reported HRQoL measures through CTSQ in participants treated with nivolumab for R/M SCCHN
Tijdsspanne: At enrollment, Up to 8 weeks
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Cancer Therapy Satisfaction Questionnaire (CTSQ)
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At enrollment, Up to 8 weeks
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Distribution of patient reported HRQoL measures through WPAI:GH in participants treated with nivolumab for R/M SCCHN
Tijdsspanne: At enrollment, Up to 8 weeks
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Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)
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At enrollment, Up to 8 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
13 augustus 2020
Primaire voltooiing (Werkelijk)
18 oktober 2021
Studie voltooiing (Werkelijk)
18 oktober 2021
Studieregistratiedata
Eerst ingediend
8 september 2021
Eerst ingediend dat voldeed aan de QC-criteria
24 september 2021
Eerst geplaatst (Werkelijk)
6 oktober 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 mei 2022
Laatste update ingediend die voldeed aan QC-criteria
2 mei 2022
Laatst geverifieerd
1 mei 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Neoplasmata, glandulair en epitheel
- Hoofd- en nekneoplasmata
- Neoplasmata, plaveiselcel
- Carcinoom
- Carcinoom, plaveiselcel
- Plaveiselcelcarcinoom van hoofd en hals
- Moleculaire mechanismen van farmacologische werking
- Antineoplastische middelen
- Antineoplastische middelen, immunologisch
- Immuun Checkpoint-remmers
- Nivolumab
Andere studie-ID-nummers
- CA209-7F9
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