About this trial
To perform a multi-site prospective study assessing, both subjectively and objectively, the gender disparities in speech outcomes of patients using TEP after total laryngectomy.
The investigators hypothesize that speech outcomes, both subjective and objective measures, will be significantly poorer for female patients compared to male patients. The outcome of the study is to prospectively assess both subjective and objective gender disparities in voice and speech outcomes of patients using TEP after total laryngectomy across a multiple institutions. The investigators hypothesize that both subjective and objective measurements of voice, speech and quality of life will be poorer for female patients in comparison to male patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male and female subjects who have completed total laryngectomy and are using TEP
Disqualifiers
Subjects who have not completed total laryngectomy and are not using TEP
Trial population
patients with advanced laryngeal cancer who have completed total laryngectomy requiring use of alternative methods to produce voice along with extensive speech rehabilitation.
Trial design
Other
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
FACT-H&N (Functional Assessment of Cancer Therapy - Head & Neck)
Patient reported survey.
AVHI (Alaryngeal Voice Handicap Index)
Patient reported survey.
Secondary outcomes
GRBAS - Grade, Roughness, Breathiness, Asthenia, and Strain
Examiner-based interpretation of roughness/breathiness of patient's voice. Scale of 0-3, 3 indicating severe, 0 indicating normal
Sustained phonation time
A measurement in seconds of how long a patient can sustain phonation.
Fundamental frequency
A measurement of frequency of voice during alaryngeal speech/sustained phonation
Sponsors and contacts
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University of California, Davis
Lead sponsor
University of California, San Diego
Collaborator