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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Laryngectomy

Intervention / Treatment
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* Device: Reinforced prosthesis
* Device: Standard prosthesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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voice rehabilitation, reinforced voice prosthesis, laryngectomy, total pharyngolaryngectomy, total circular pharyngolaryngectomy, phonatory prosthesis