Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Minnesota
-
Minneapolis, Minnesota, Spojené státy, 55455
- Masonic Cancer Center, University of Minnesota
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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- Voluntary written informed consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Swallowing Function Scores
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
General Quality of Life
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Bevan Yueh, MD, MPH, Masonic Cancer Center, University of Minnesota
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2008NTLS104
- 0809M45481 (Jiný identifikátor: IRB, University of Minnesota)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .