Cost-effectiveness Analysis of Vocal Rehabilitation With Strengthened Tracheoesophageal Voice Implant Prosthesis Versus Standard Voice Prosthesis in Case of Repeated Intra-prosthetic Leakage After Total Laryngectomy (PHRASAL)

The purpose of this study is to determine the cost-effectiveness of vocal rehabilitation with reinforced inter-tracheoesophageal voice prosthesis versus standard voice prosthesis in case of repeated intra-prosthetic leakage in total laryngectomy patients.

This is a one year medico-economic study involving patients carrying a standard voice prosthesis implant and having undergone 2 successive prosthesis replacements within 3 months of interval and/or requiring at least 4 changes in the last 12 months, for intraprosthetic leakage.

Eligible subjects will be randomized in 2 groups: reinforced prosthesis with silver coating and double valve (Dual Valve) or standard prosthesis (single unreinforced valve), of the same model as the prosthesis previously implanted in the patient.

Study Overview

• Status: Active, not recruiting
• Conditions: Laryngectomy
• Intervention / Treatment: Device: Reinforced prosthesis; Device: Standard prosthesis

Detailed Description

Prosthetic voice rehabilitation is a widespread practice that allows the patient to resume phonation quickly after total laryngectomy/total pharyngolaryngectomy/total circular pharyngolaryngectomy.

When the longevity of the implant is abnormally short (less than 3 months), the multiplication of changes is likely to increase the risk of overall morbidity related to maintaining the functionality of the voice prosthesis and to alter the patient's quality of life.

Reinforced innovative prostheses, currently not supported by the French Social Security, delay the occurrence of intraprosthetic leakage compared to standard prostheses.

This study assesses the economic efficiency from a societal perspective and a one-year time horizon, from vocal rehabilitation with reinforced inter-tracheoesophageal prosthesis versus standard voice prosthesis in case of intra-tracheal leakage in total laryngectomy patients.

Patients are randomized in 2 arms. Arm A usual care with reinforced prosthesis, or arm B usual care with standard prosthesis. Each patient is followed during 12 months.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU Bordeaux
  • Caen, France
    • CHU Caen
  • Montpellier, France
    • CHU Gui de Chauliac
  • Nantes, France
    • Chu Nantes
  • Nîmes, France
    • CHU Nimes
  • Paris, France
    • Hôpital Bichat
  • Paris, France
    • Hôpital Tenon
  • Paris, France
    • Clcc Institut Curie
  • Poitiers, France
    • CHRU de Poitiers
  • Rennes, France
    • Chru Pontchaillou
  • Strasbourg, France
    • Hôpital Hautepierre
  • Toulouse, France
    • Institut Universitaire du Cancer de Toulouse-Oncopole
  • Vandœuvre-lès-Nancy, France
    • Institut de Cancérologie de Lorraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient treated surgically by total laryngectomy or total pharyngolaryngectomy or total circular pharyngolaryngectomy and carrying a voice prosthesis for at least 12 months
• Patient carrying a standard voice prosthesis and having undergone 2 successive prosthesis replacements within 3 months of interval and/or requiring at least 4 changes in the last 12 months, for intraprosthetic leakage
• Patients carrying a voice prosthesis, irrespective of the mark/model, of diameters between 16 and 20 French, and of length between 6 and 14 mm.
• Prosthetic replacement available under local or general anaesthesia
• Patient with primary cancer remission status
• Patient agreeing to participate in the study and having given oral, express and informed consent

Exclusion Criteria:

• Patient with local, regional or metastatic tumor evolution
• Patient who has had a first voice prosthesis for less than 12 months.
• Patient with peri-prosthetic leakage
• Patient presenting a dysfunction of the voice prosthesis not linked to an intra-prosthetic leak
• Patients whose tracheal fistula is no longer opened, or justifying a new tracheoesophageal puncture
• Patients with a voice prosthesis of a diameter strictly greater than 20 French
• Patients with voice prosthesis of strictly less than 6 mm or greater than 14 mm length
• Patient under anti-fungal treatment during the month prior to inclusion
• Adult protected patients
• Inability to complete the questionnaires
• Patients with an estimated life expectancy of less than 1 year
• Patients not affiliated to French National Health care insurance
• Patients under the protection of Justice
• Pregnant woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reinforced prosthesis; Implementation of a reinforced prosthesis with silver coating and double valve, whatever which type of prosthesis the patient previously had.	Device: Reinforced prosthesis; Implementation of a reinforced prosthesis during a medical consultation or under local anesthesia, after removal of the former prosthesis, in case of intraprothetic leakage.
Active Comparator: Standard prosthesis; Implementation of a standard prosthesis (simple valve, not reinforced), similar to the prosthesis the patient previously had.	Device: Standard prosthesis; Implementation of a standard prosthesis during a medical consultation or under local anesthesia, after removal of the former prosthesis, in case of intraprothetic leakage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental Cost-Effectiveness Ratio (cost per avoided prosthesis change), based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard prosthesis	Effectiveness will be measured by the mean of number of prosthesis changes in each arm. Costs will be measured by 1) Outpatient resource consumption collected in a declarative patient questionnaire and 2) Hospital care resources using the database of the Medicalised Information System Program of each recruiting site	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental cost-utility ratio, based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard one	Utility will be measured by Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D 5L) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible. Cost will be measured as described in the Primary Outome Measure	12 months
Quality of life using Euroqol-5 Dimensions (EQ-5D) questionnaire	Score of EQ-5D 5L. health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible, each answer corresponds to a score ranging from 1 to 5.	Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement
Quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)	Score of the QLQ-C30 questionnaire, including 30 questions assessing some aspects of the quality of life of cancer patients. The total score ranges from 0 to 100.	Baseline, at 3 months, 6 months, 9 months and 12 months
Quality of life using the Head and Neck Quality of Life Questionnaire (QLQ - H&N 35)	Score of the QLQ - H&N 35, including 35 questions assessing other aspects of quality of life in patients with head and neck cancer. The total score ranges from 0 to 100	Baseline, 3 months, 6 months, 9 months and 12 months
Quality of voice	score of the Voice Handicap Index: 10 items assessing the patient's voice, with 5 possible answers per item ranking from "never" to "always". The total score ranges from 0 to 120	Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement
Quality of voice assessed by the patient	Voice quality assessed by the patient and by a patient's relative with a numeric scale ranging from 0 "worst possible voice" to 10 "best possible voice", before and after each voice prosthesis change	Baseline, 3 months, 6 months, 9 months and 12 months
Patient quality of voice assessed by the patient's relative	Voice quality assessed by the patient's relative if present at time of prosthesis replacement, with a numeric scale ranging from 0 "worst possible voice" to 10 "best possible voice", before and after each voice prosthesis change	Baseline, at 3 months, 6 months, 9 months and 12 months
Trips induced by voice prosthesis replacement	Number of trips made by the patient for his prosthesis replacement, declared by the patient	12 months
Time spent out of home	Time spent by the patient out of home induced by voice prosthesis leaks, declared by the patient	12 months
Feeding interruption	Number of days or hours during which the patient could not eat due to voice prosthesis leak, declared by the patient	12 months
Interruption of oral communication	Number of days or hours during which the patient could not speak due to voice prosthesis leak, declared by the patient	12 months
Frequency of voice prosthesis replacements	Number of voice prosthesis replacements	12 months
Lifetime of voice prostheses	Date of voice prosthesis replacement	12 months
Complications due to voice prosthesis	Number and type of complications due to voice prosthesis	12 months
Patient's pain due to voice prosthesis replacement	Pain due to voice prosthesis replacement assessed by a numeric scale ranging from 0 "no pain" to 10 "worst pain", asked to the patient before and after each voice prosthesis change	at each prosthesis replacement, during the 12 months follow-up
Patient's dysphagia due to voice prosthesis replacement	Score of the Dysphagia Handicap Index 10 items assessing the patient's dysphagia, with 5 possible answers per item ranking from "never" to "always". Total score ranges from 0 to 120.	Baseline and at each prosthesis replacement
Annual net financial benefit of developping the use of reinforced prosthesis	Net financial benefit of the development of reinforced phonatory implants' compared to standard implants'use for patients treated with thyroid lobectomy and with repeated intraprosthetic dysfunction, through a Budget Impact Analysis (BIA) with a 5-years' time horizon and a National Health Insurance's perspective (NHI). Methods: Financial consequences for the NHI of several scenarii of development of the reinforced phonatory implants' will be represented in a table, year by year and over 5 years, in terms of cost per scenario and in terms of cost difference between the scenarii (showing savings or additional costs generated by choosing to develop the reinforced phonatory implant).	5 years

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Olivier Malard, Md PhD, CHU de Nantes

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: laryngectomy; phonatory prosthesis; voice rehabilitation; reinforced voice prosthesis; total pharyngolaryngectomy; total circular pharyngolaryngectomy
• Other Study ID Numbers: RC19_0180

Drug and device information, study documents

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