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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 (PHRASAL)

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ClinicalTrials.gov Identifier: NCT04100954
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Laryngectomy Device: Reinforced prosthesis Device: Standard prosthesis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : January 2, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 [ Time Frame: 12 months ]
    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


Secondary Outcome Measures :
  1. Incremental cost-utility ratio, based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard one [ Time Frame: 12 months ]

    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


  2. Quality of life using Euroqol-5 Dimensions (EQ-5D) questionnaire [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement ]
    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.

  3. Quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: Baseline, at 3 months, 6 months, 9 months and 12 months ]
    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.

  4. Quality of life using the Head and Neck Quality of Life Questionnaire (QLQ - H&N 35) [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]
    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

  5. Quality of voice [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement ]
    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

  6. Quality of voice assessed by the patient [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ]
    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

  7. Patient quality of voice assessed by the patient's relative [ Time Frame: Baseline, at 3 months, 6 months, 9 months and 12 months ]
    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

  8. Trips induced by voice prosthesis replacement [ Time Frame: 12 months ]
    Number of trips made by the patient for his prosthesis replacement, declared by the patient

  9. Time spent out of home [ Time Frame: 12 months ]
    Time spent by the patient out of home induced by voice prosthesis leaks, declared by the patient

  10. Feeding interruption [ Time Frame: 12 months ]
    Number of days or hours during which the patient could not eat due to voice prosthesis leak, declared by the patient

  11. Interruption of oral communication [ Time Frame: 12 months ]
    Number of days or hours during which the patient could not speak due to voice prosthesis leak, declared by the patient

  12. Frequency of voice prosthesis replacements [ Time Frame: 12 months ]
    Number of voice prosthesis replacements

  13. Lifetime of voice prostheses [ Time Frame: 12 months ]
    Date of voice prosthesis replacement

  14. Complications due to voice prosthesis [ Time Frame: 12 months ]
    Number and type of complications due to voice prosthesis

  15. Patient's pain due to voice prosthesis replacement [ Time Frame: at each prosthesis replacement, during the 12 months follow-up ]
    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

  16. Patient's dysphagia due to voice prosthesis replacement [ Time Frame: Baseline and at each 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.

  17. Annual net financial benefit of developping the use of reinforced prosthesis [ Time Frame: 5 years ]

    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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100954


Contacts
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Contact: Olivier MALARD, MD PhD +33 2 44 76 68 72 olivier.malard@chu-nantes.fr
Contact: Cécile DERT +33 2 53 48 28 52 cecile.dert@chu-nantes.fr

Locations
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France
Chu Bordeaux
Bordeaux, France
Contact: Erwan DE MONES DEL PUJOL, md    0556795442    erwan.de.mones-del-pujol@chu-bordeaux.fr   
CHU CAEN
Caen, France
Contact: Emmanuel BABIN, md    0231065787    e.babin@baclesse.unicancer.fr   
Chu Gui de Chauliac
Montpellier, France
Contact: Renaud GARREL, md    0467336897    r-garrel@chu-montpellier.fr   
Chu Nantes
Nantes, France
Contact: OLIVIER MALARD, MD    0240083461    olivier.malard@chu-nantes.fr   
Chu Nimes
Nîmes, France
Contact: Benjamin LALLEMANT, md    0466683278    benjamin.LALLEMANT@chu-nimes.fr   
Clcc Institut Curie
Paris, France
Contact: Olivier CHOUSSY, md    0144324535    olivier.choussy@curie.fr   
Hopital Bichat
Paris, France
Contact: SEBASTIEN ALBERT, MD    0140257714    SEBASTIEN.ALBERT@APHP.FR   
Hopital Tenon
Paris, France
Contact: BERTRAND BAUJAT, MD    0156016417    BERTRAND.BAUJAT@APHP.FR   
Chru de Poitiers
Poitiers, France
Contact: Xavier DUFOUR, md    0549443848    xavier.dufour@chu-poitiers.fr   
Chru Pontchaillou
Rennes, France
Contact: Franck JEGOUX, md    0299284286    franck.JEGOUX@chu-rennes.fr   
Hopital Hautepierre
Strasbourg, France
Contact: Philippe SCHULTZ, md    0388127636    philippe.schultz@chru-strasbourg.fr   
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse, France
Contact: Sébastien VERGEZ, md    0531155369    Vergez.Sebastien@iuct-oncopole.fr   
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France
Contact: Gilles DOLIVET, md    0383598446    g.dolivet@nancy.unicancer.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Olivier Malard, Md PhD CHU de Nantes

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04100954    
Other Study ID Numbers: RC19_0180
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
phonatory prosthesis
voice rehabilitation
reinforced voice prosthesis
laryngectomy
total pharyngolaryngectomy
total circular pharyngolaryngectomy