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Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer

3 décembre 2015 mis à jour par: University of Minnesota

The purpose of this prospective, multi-institutional, observational cohort study is to determine if an initial surgical approach leads to better function and quality of life than primary chemoradiation in a subset of patients with advanced hypopharyngeal and laryngeal cancers.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

At the time of registration patients will be categorized into 2 groups based on the initial treatment plan as either chemoradiation-based or surgically-based (laryngectomy). Treatment will be assigned by the patient's physician, it will not be assigned by the study.

Patients will be asked to complete a series of 4 questionnaires addressing swallowing function, generic health status, head and neck cancer-specific quality of life, and self-reported speech function at 3 time points (baseline, 6 months and 12 months after the end of treatment). The treating physician will provide basic clinical information at these same time points. In centers where swallowing and voice assessments are done as part of standard of care, data from these studies will also be provided.

Study entry is open to all adults regardless of gender or ethnic background. Specific information regarding the definitive treatment (surgery or chemoradiation) will be provided to the patient by the treating physician as part of the routine standard of care. Any treatment related side effects, as well as the duration of therapy and follow-up will be managed by the treating physician. Participation in this study will have no effect on the initial treatment decisions or the course of care.

Type d'étude

Observationnel

Inscription (Réel)

279

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

États-Unis
- Minnesota
  - Minneapolis, Minnesota, États-Unis, 55455
    - Masonic Cancer Center, University of Minnesota

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

Newly diagnosed squamous cell carcinoma of the larynx (cartilage invading-T3 and all T4) or hypopharynx (T2 and T3) for which curative treatment is planned. The tumor must be resectable with total laryngectomy alone as determined by the treating surgeon - this requirement is regardless of whether the surgery of chemoradiation is planned for the patient.

La description

Inclusion Criteria:

Willingness and ability to complete self-administered follow-up questionnaires over the course of one year as determined by a member of the research team
Voluntary written informed consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Must be at least 18 years of age

Exclusion Criteria:

Require a resection that would involve more than the standard laryngectomy (total pharyngectomy, esophagectomy)
Undergo partial laryngectomy, when open or endoscopic
Have previously altered anatomy of the upper aerodigestive tract
Have pre-existing dysphagia unrelated to the tumor, or neurologic disorders that could affect swallowing (Parkinson's, cerebrovascular accidents)
Have prior malignant disease of the upper aerodigestive tract
Have prior radiation therapy to the head and neck region
Metastatic disease
Unable to complete self-administered questionnaires written in simple English for cognitive, psychiatric, or other reasons that in the opinion of the enrolling investigator is likely to interfere with participation in this clinical study.

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

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
Patients Treated with Laryngectomy Patients initially treated with laryngectomy and followed for 12 months after receiving this treatment.
Patients Treated with Chemoradiation Patients treated initially with chemoradiation and followed for 12 months after receiving treatment.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Swallowing Function Scores Délai: 12 months after Treatment	The primary outcome will be self-reported swallowing function (M.D. Anderson Dysphagia Inventory questionnaire - MDADI) 12 months after treatment. Analysis will compare MDADI scores of patients treated initially with laryngectomy vs. those of patients treated initially with chemoradiation.	12 months after Treatment

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
General Quality of Life Délai: PreTreatment, 6 Months and 12 Months After Treatment	The SF-12 Quality of Life questionnaire will be used to assess general health status. The SF-12 contains one or two items that measure each of eight domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS).	PreTreatment, 6 Months and 12 Months After Treatment
Speech Assessment Délai: PreTreatment, 6 Months and 12 Months After Treatment	Speech analysis will focus primarily on speech intelligibilty and acceptability to both clinicians and naive listeners, and less on voice quality per se using the Voice Handicap Index. The Voice Handicap Index (VHI) measures the influence of voice problems on a patient's quality of life.	PreTreatment, 6 Months and 12 Months After Treatment
Head and Neck Quality of Life Délai: PreTreatment, 6 Months and 12 Month After Treatment	The University of Washington Quality of Life Assessment Questionnaire will be administered. This questionnaire is specifically designed to capture head and neck cancer-specific function.	PreTreatment, 6 Months and 12 Month After Treatment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Minnesota

Collaborateurs

American Academy of Otolaryngology-Head and Neck Surgery Foundation

American Head and Neck Society

Les enquêteurs

Chercheur principal: Bevan Yueh, MD, MPH, Masonic Cancer Center, University of Minnesota

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

1 septembre 2009

Achèvement primaire (Réel)

1 août 2015

Achèvement de l'étude (Réel)

1 août 2015

Dates d'inscription aux études

Première soumission

17 mars 2010

Première soumission répondant aux critères de contrôle qualité

18 mars 2010

Première publication (Estimation)

19 mars 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

4 décembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 décembre 2015

Dernière vérification

1 décembre 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

2008NTLS104
0809M45481 (Autre identifiant: IRB, University of Minnesota)

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 .