Quality of Life and Voice Perception in Patients Laryngoctomized Phonatory Wearers

NCT06086119 | Unknown

• 1 other identifier: RS1497/21
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Quality of Life; Larynx Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Interventions

to assess the voice perception of the patient undergoing phonatory prosthesis placement surgery by evaluating the optimal score (>30) in terms of VHI. DIAGNOSTIC_TEST

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

Patients who will be subjected to total laryngectomy and placement of voice prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• San Giovanni Addolorata Hospital: collaborator
• Azienda Policlinico Umberto I: collaborator

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: October 17, 2023
• Study Start: May 4, 2021
• Primary Completion: October 15, 2022
• Study Completion: May 4, 2024
• Last Updated: October 17, 2023

Record last verified: 2023-06

Locations

IT (1)