A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO) (VOLUME-PRO)
2 mai 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
509
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New Jersey
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Mount Laurel, New Jersey, États-Unis, 08054
- Local Institution
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
13 août 2020
Achèvement primaire (Réel)
18 octobre 2021
Achèvement de l'étude (Réel)
18 octobre 2021
Dates d'inscription aux études
Première soumission
8 septembre 2021
Première soumission répondant aux critères de contrôle qualité
24 septembre 2021
Première publication (Réel)
6 octobre 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 mai 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 mai 2022
Dernière vérification
1 mai 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par type histologique
- Tumeurs
- Tumeurs par site
- Tumeurs, glandulaires et épithéliales
- Tumeurs de la tête et du cou
- Tumeurs à cellules squameuses
- Carcinome
- Carcinome épidermoïde
- Carcinome épidermoïde de la tête et du cou
- Mécanismes moléculaires de l'action pharmacologique
- Agents antinéoplasiques
- Agents antinéoplasiques immunologiques
- Inhibiteurs de point de contrôle immunitaire
- Nivolumab
Autres numéros d'identification d'étude
- CA209-7F9
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .