Laryngectomy Clinical Trial
— PHRASALOfficial title:
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
Verified date | June 2023 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 81 |
Est. completion date | January 31, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Bordeaux | Bordeaux | |
France | CHU CAEN | Caen | |
France | Chu Gui de Chauliac | Montpellier | |
France | Chu Nantes | Nantes | |
France | Chu Nimes | Nîmes | |
France | Clcc Institut Curie | Paris | |
France | Hopital Bichat | Paris | |
France | Hopital Tenon | Paris | |
France | Chru de Poitiers | Poitiers | |
France | Chru Pontchaillou | Rennes | |
France | Hopital Hautepierre | Strasbourg | |
France | Institut Universitaire du Cancer de Toulouse-Oncopole | Toulouse | |
France | Institut de Cancerologie de Lorraine | VandÅ“uvre-lès-Nancy |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Trips induced by voice prosthesis replacement | Number of trips made by the patient for his prosthesis replacement, declared by the patient | 12 months | |
Secondary | Time spent out of home | Time spent by the patient out of home induced by voice prosthesis leaks, declared by the patient | 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Frequency of voice prosthesis replacements | Number of voice prosthesis replacements | 12 months | |
Secondary | Lifetime of voice prostheses | Date of voice prosthesis replacement | 12 months | |
Secondary | Complications due to voice prosthesis | Number and type of complications due to voice prosthesis | 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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