Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life

Cancer of the Larynx Clinical Trial

Official title:

Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01607138
• Other study ID #: TASMC-12-CTJ-224-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: May 24, 2012
• Last updated: May 25, 2012
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Jacob T Cohen, MD
• Phone: 0524266364
• Email: jacobc[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients post total laryngectomy with voice prothesis

Exclusion Criteria:

• patients who can not read and respod to questions

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cancer of the Larynx

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

References & Publications (1)

* 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech and swallowing characteristics of patients post laryngectomy	After recording the patients' speech the speech characteristics will be analysed according to specific parameters. Also after performing swallowing eveluation swallowing disturbances will be diagnosed and described.	At the completion of data collection -1 year	No
Secondary	The relationship between speech and swallowing disturbances of patients post laryngectomy	After analyzing the speech and swallowing disturbances of patients post laryngectomy, the relationship between these variables will be examined.	1 year at the completion of data collection	No