Assessing quality of life and voice perception in patients with laryngeal cancer after surgery
Quality of Life and Voice Perception in Patients Laryngoctomized Phonatory Wearers
This study is testing how a voice prosthesis affects the quality of life and voice perception in patients who have had surgery for laryngeal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 31 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06086119 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients undergoing total laryngectomy surgery and the subsequent placement of a phonatory prosthesis. It aims to evaluate the voice perception of these patients by measuring their Voice Handicap Index (VHI) scores. The study is multicenter and prospective, involving multiple institutions to gather comprehensive data on the quality of life post-surgery. Participants will be monitored to assess the impact of the prosthesis on their daily communication and overall well-being.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who are scheduled for total laryngectomy and agree to phonatory prosthesis placement.
Not a fit: Patients who have not undergone total laryngectomy or who refuse the placement of a phonatory prosthesis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of voice rehabilitation and improve the quality of life for laryngectomized patients.
How similar studies have performed: Other studies have shown promising results in voice rehabilitation for laryngectomized patients, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who will undergo laryngeal demolition surgery, total laryngectomy, who agree to phonatory prosthesis placement * Patients who have undergone previous total laryngectomy surgery and intend to undergo placement of phonatory prosthesis. * Age \> 18 years * Written informed consent Exclusion Criteria: * Patients who have not undergone demolitive surgical treatment by total laryngectomy or who do not accept the placement of phonatory prosthesis. * Patients who are unable to complete questionnaires/follow the rehabilitation pathway
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.