Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, Davis

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

FACT-H&N (Functional Assessment of Cancer Therapy - Head & Neck)

Patient reported survey.

Time frame
Through study completion; 3 years (anticipate completion by June 2025)
2

AVHI (Alaryngeal Voice Handicap Index)

Patient reported survey.

Time frame
Through study completion; 3 years (anticipate completion by June 2025)

Secondary outcomes

1

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

Time frame
Through study completion; 3 years (anticipate completion by June 2025)
2

Sustained phonation time

A measurement in seconds of how long a patient can sustain phonation.

Time frame
Through study completion; 3 years (anticipate completion by June 2025)
3

Fundamental frequency

A measurement of frequency of voice during alaryngeal speech/sustained phonation

Time frame
Through study completion; 3 years (anticipate completion by June 2025)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

University of California, San Diego

Collaborator