Quality of Life and Voice Perception in Patients Laryngoctomized Phonatory Wearers

Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Larynx Cancer
• Intervention / Treatment: Diagnostic test: to assess the voice perception of the patient undergoing phonatory prosthesis placement surgery by evaluating the optimal score (>30) in terms of VHI.

• Study Type: Observational
• Enrollment (Estimated): 31

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00144
    • Recruiting
    • "Regina Elena" National Cancer Institute
    • Contact: Raul Pellini, MD; Phone Number: ND; Email: raul.pellini@ifo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients who will be subjected to total laryngectomy and placement of voice prosthesis; Prospective, multicenter observational study involving patients who will be subjected to total laryngectomy and placement of voice prosthesis.Evaluate the patient's quality of life and voice perception underwent surgery for the placement of a voice prosthesis, through the administration of validated quality of life questionnaires: EORTC QLQ - H&N35; EORTC QLQ -C30, V-RQOL, VHI, SECEL3,4

Diagnostic test: to assess the voice perception of the patient undergoing phonatory prosthesis placement surgery by evaluating the optimal score (>30) in terms of VHI.; Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the patient's quality of life and voice perception underwent surgery for the placement of a voice prosthesis	Evaluate the perception of the voice of the patient undergoing surgery of voice prosthesis positioning, evaluating the optimal score (>30) in terms of VHI. To calculate the sample size we based our estimate on the percentage of patients not undergoing voice prosthesis with a VHI score greater than 30 (Good Score). Such percentage is approximately 35%, a figure reported in the literature. Assuming a difference of 25% in terms of percentage of patients undergoing voice prosthesis who have a VHI score greater than 30 (60%) to ensure a power (1-β) equal to 80% and an α error of 5%, it will be necessary to enlist a total of 31 patients with the required requirements. Descriptive statistics will be calculated for all variables of interest. The associations will come evaluated using Fisher's exact test. Differences between subgroups will be assessed using the Mann-Whitney U test. All statistical analyzes were conducted using SPSS statistical software (version 21.0)	Enlistment period: 2 years Total duration of the study: 36 months

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute
• Collaborators: Azienda Policlinico Umberto I; San Giovanni Addolorata Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Actual): October 15, 2022
• Study Completion (Estimated): May 4, 2024

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Laryngeal Diseases; Laryngeal Neoplasms
• Other Study ID Numbers: RS1497/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No