NCT04690166

Brief Summary

Purpose of the study is the validation and cultual adaptation of the Turkish translation of the London Speech Evaluation Scale (LSE-T), so that it would be used as an assessment tool for Turkish head and neck cancer patients. There is no validated Turkish version of LSE to measure severity of perceptual speech in head and neck cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

December 26, 2020

Last Update Submit

July 28, 2021

Conditions

Keywords

Perceptualspeecharticulationneckcancer

Outcome Measures

Primary Outcomes (2)

  • Validation of the Turkish Translation of London Speech Evaluation Scale

    Turkish Translation of London Speech Evaluation Scale consists of 6 parameters and 4 scores. The minimum score is 0 and maximum score is 24. The lower scores mean a better than high scores.

    Baseline

  • Validation of the Turkish Translation of London Speech Evaluation Scale

    Turkish Translation of London Speech Evaluation Scale consists of 6 parameters and 4 scores. The minimum score is 0 and maximum score is 24. The lower scores mean a better than high scores.

    6 weeks

Study Arms (2)

Cancer Patients

In outpatients clinic, the first group consists of 60 head and neck cancer patients who were treated by ours. The participants will given the document consists that "bit, bet, but" words and also a brief part of "Diyet passage" who written by Omer Seyffettin. The speech record of patients who read to document, will evaluated by three judges (otorhinolaryngologist). Three judges will scoring to Turkish translation of London Speech Evaluation Scale (LSE-T), consists of 6 parameters. After the six weeks, the records were scored again as randomisely.

Other: The speech records related to the reading document

Healty Control

In outpatients clinic, the control group consists of 60 patients who have not speech and hear impairments. The participants will given the document consists that "bit, bet, but" words and also a brief part of "Diyet passage" who written by Omer Seyffettin. The speech record of patients who read to document, will evaluated by three judges (otorhinolaryngologist). Three judges will scoring to Turkish translation of London Speech Evaluation Scale (LSE-T), consists of 6 parameters. After the six weeks, the records were scored again as randomisely.

Other: The speech records related to the reading document

Interventions

The document consists "bit, bet, but" words and Diyet passage. Volunteers will read the document in front of the microphone and also the speech will recorded by a computer.

Cancer PatientsHealty Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with oral, oropharyngeal cancer and healthy adults

You may qualify if:

  • Able to speak, read, understand and write in Turkish
  • History of oral, orofarengeal cancer
  • Volunteers who accept the informed consent

You may not qualify if:

  • Mental disorders
  • Cognitive limitations
  • Able not to speak, read, understand and write in Turkish
  • Underwent any surgery last six month
  • Permanent tracheostomy, total laryngectomy
  • Pregnancy
  • Out of age 18-70 years old
  • Adults who do not accept the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof Dr Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (1)

  • Dwivedi RC, Rose SS, Chisholm EJ, Kerawala CJ, Clarke PM, Nutting CM, Rhys-Evans PH, Harrington KJ, Kazi R. Development and validation of first-ever speech-specific perceptual speech evaluation tool for patients with head and neck cancer: the London speech evaluation (LSE) scale. Head Neck. 2012 Jan;34(1):94-103. doi: 10.1002/hed.21683. Epub 2011 Apr 5.

    PMID: 21469245BACKGROUND

MeSH Terms

Conditions

Speech IntelligibilitySpeech DisordersHead and Neck NeoplasmsSpeechNeoplasms

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehaviorLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by Site

Study Officials

  • Ziya Salturk, Asso Prof,MD

    Anadolu Medical Center, In Affiliation with Johns Hopkins Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, M.D.

Study Record Dates

First Submitted

December 26, 2020

First Posted

December 30, 2020

Study Start

December 21, 2020

Primary Completion

May 21, 2021

Study Completion

May 21, 2021

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations