NCT02875795

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable head-and-neck-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

August 18, 2016

Last Update Submit

July 28, 2020

Conditions

Head and Neck Cancer

Keywords

linguisticquality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    day 0

Study Arms (1)

speech intelligibility

EXPERIMENTAL

speech intelligibility is registered by an automatic speech processing tool

Procedure: automatic speech processing tool

Interventions

automatic speech processing toolPROCEDURE
speech intelligibility

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31178430RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Virginie WOISARD, Md

    woisard.v@chu-toulouse.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 23, 2016

Study Start

January 1, 2015

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share