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Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer

3 december 2015 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

279

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

  • Verenigde Staten
    • Minnesota
      • Minneapolis, Minnesota, Verenigde Staten, 55455
        • Masonic Cancer Center, University of Minnesota

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

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.

Beschrijving

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.

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

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Swallowing Function Scores
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
General Quality of Life
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Minnesota

Medewerkers

American Academy of Otolaryngology-Head and Neck Surgery Foundation
American Head and Neck Society

Onderzoekers

  • Hoofdonderzoeker: Bevan Yueh, MD, MPH, Masonic Cancer Center, University of Minnesota

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

1 september 2009

Primaire voltooiing (Werkelijk)

1 augustus 2015

Studie voltooiing (Werkelijk)

1 augustus 2015

Studieregistratiedata

Eerst ingediend

17 maart 2010

Eerst ingediend dat voldeed aan de QC-criteria

18 maart 2010

Eerst geplaatst (Schatting)

19 maart 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

4 december 2015

Laatste update ingediend die voldeed aan QC-criteria

3 december 2015

Laatst geverifieerd

1 december 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2008NTLS104
  • 0809M45481 (Andere identificatie: IRB, University of Minnesota)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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