Clinical trial NCT01607138: Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life
Official title: Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer of the Larynx
Keywords: laryngectomy
swallowing disturbances
speech disturbances
speech intelligibility
voice prothesis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-05-28
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 adult patients, ages 35-80 y/o who underwent total laryngectomy and a trechea esophageal puncture was performed for the use of voice prothesis.

Brief summary: Swallowing and speech difficulties will be observed in patients post laryngectomy. These difficulties will cause decreased in quality of life.

Detailed description: This study will explore the characteristics of speech and swallowing problems of patients who underwent laryngectomy.The relationship between swallowing disturbances and speech difficulties will be studied and the effect of each problem on quality of life will be messured.

Eligibility criteria: Inclusion Criteria:

* patients post total laryngectomy with voice prothesis

Exclusion Criteria:

* patients who can not read and respod to questions

Primary outcomes:
measure: Speech and swallowing characteristics of patients post laryngectomy
timeFrame: At the completion of data collection -1 year
Secondary outcomes:
measure: The relationship between speech and swallowing disturbances of patients post laryngectomy
timeFrame: 1 year at the completion of data collection
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: Jacob T Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: * Maclean, J., Cotton, S., & Perry, A. (2009). Post-laryngectomy: it's hard to swallow: an Australian study of prevalence and self-reports of swallowing function after a total laryngectomy. Dysphagia, 24(2), 172-179. * Maclean, J., Cotton, S., & Perry, A. (2009). Dysphagia following a total laryngectomy: the effect on quality of life, functioning, and psychological well-being. Dysphagia, 24(3), 314-321. * McHorney, C. A., Robbins, J., Lomax, K., Rosenbek, J. C., Chignell, K., Kramer, A. E., & Bricker, D. E. (2002). The SWAL-QOL and SWAL-CARE outcomes tool for oropharyngeal dysphagia in adults: III. Documentation of reliability and validity. Dysphagia, 17(2), 97-114. * Platteaux, N., Dirix, P., Dejaeger, E., & Nuyts, S. (2010). Dysphagia in head and neck cancer patients treated with chemoradiotherapy. Dysphagia, 25(2), 139-152. * Kapila,M., Deore,N., Palav,R.S., Kazi,R.A., Shah,R.P., & Jagade,M.V.(2011). A brief review of voice restoration following total laryngectomy. Indian Journal of Cancer,48(1),99-104. * Rizzo,B.p.,Maronato,F.,Marchiori,C., Gava,A., &Da Mosto, M,C.(2008). Long-Term Quality of Life After Total Laryngectomy and Postoperative Radiotherapy Versus Concurrent Chemoradiotherapy for Laryngeal Preservation. The Laryngoscope.118,300-306 (2010). Total Laryngectomy.OtorhinolaryngologyMohebati,A. Mohebati,A & * Shah ,p .j , International Journal, 2(3), pp 207-214