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Carcinologic Speech Severity Index (C2SI)

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
automatic speech processing tool
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Cancer focused on measuring linguistic, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Oral and Pharyngeal cancer T2 to T4 for having a wide dynamic of deficit
  • Treatment by surgery and/or radiotherapy and/or chemotherapy
  • Delay after the end of the treatment of minimum 6 months.

Exclusion Criteria:

  • Patients with a previous speech disorders (ie stuttering… )
  • Patients not able to perform the whole task

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    speech intelligibility

    Arm Description

    speech intelligibility is registered by an automatic speech processing tool

    Outcomes

    Primary Outcome Measures

    carcinologic speech severity index
    The main objective is to demonstrate that the carcinologic speech severity index (C2SI), obtained by an automatic speech processing tool, produces equivalent or superior outcomes than a score of speech intelligibility obtained by human listeners, in terms of quality of life foreseeing the speech handicap, after the treatment of oral and/or pharyngeal cancer.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 18, 2016
    Last Updated
    July 28, 2020
    Sponsor
    University Hospital, Toulouse
    Collaborators
    University Jean-Jaures, Toulouse, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02875795
    Brief Title
    Carcinologic Speech Severity Index
    Acronym
    C2SI
    Official Title
    A Speech Disorders Severity Index to Measure the Impact of Oral and Pharyngeal Cavity on Speech Production
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    December 31, 2017 (Actual)
    Study Completion Date
    December 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Toulouse
    Collaborators
    University Jean-Jaures, Toulouse, France

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The hypothesis of the present study is that an automatic assessment technic can measure the impact of the speech disorders on the communication abilities giving a severity index of speech in patients treated for head and neck and particularly for oral and pharyngeal cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer
    Keywords
    linguistic, quality of life

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    124 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    speech intelligibility
    Arm Type
    Experimental
    Arm Description
    speech intelligibility is registered by an automatic speech processing tool
    Intervention Type
    Procedure
    Intervention Name(s)
    automatic speech processing tool
    Primary Outcome Measure Information:
    Title
    carcinologic speech severity index
    Description
    The main objective is to demonstrate that the carcinologic speech severity index (C2SI), obtained by an automatic speech processing tool, produces equivalent or superior outcomes than a score of speech intelligibility obtained by human listeners, in terms of quality of life foreseeing the speech handicap, after the treatment of oral and/or pharyngeal cancer.
    Time Frame
    day 0

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Oral and Pharyngeal cancer T2 to T4 for having a wide dynamic of deficit Treatment by surgery and/or radiotherapy and/or chemotherapy Delay after the end of the treatment of minimum 6 months. Exclusion Criteria: Patients with a previous speech disorders (ie stuttering… ) Patients not able to perform the whole task
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Virginie WOISARD, Md
    Organizational Affiliation
    woisard.v@chu-toulouse.fr
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31178430
    Citation
    Balaguer M, Boisguerin A, Galtier A, Gaillard N, Puech M, Woisard V. Assessment of impairment of intelligibility and of speech signal after oral cavity and oropharynx cancer. Eur Ann Otorhinolaryngol Head Neck Dis. 2019 Oct;136(5):355-359. doi: 10.1016/j.anorl.2019.05.012. Epub 2019 Jun 6.
    Results Reference
    result

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    Carcinologic Speech Severity Index

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