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Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy

Primary Purpose

Tongue Cancer, Jaw Cancer, Oral Cancer

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Speech-language guidance
Speech therapy exercises for swallowing
Speech therapy exercises for speech
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tongue Cancer focused on measuring Speech therapy, Dysphagia, Speech Intelligibility, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over 18 Years
  • Tongue and/or Jaw Neoplasm
  • Submitted to surgical treatment

Exclusion Criteria:

  • Under 18 Years
  • Cognitive impairment or deficits in language comprehension
  • Previous speech therapy intervention
  • Recurrence or active disease
  • Death during the intervention

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Changes in Quality of Life Scores related to swallowing
To measure the changes in Quality of Life related to swallowing it was used the questionnaire Dysphagia Handicap Index (DHI)
Changes in Quality of Life Scores related to speech
To measure the changes in Quality of Life related to speech it was used the questionnaire Speech Handicap Index (SHI)

Secondary Outcome Measures

Changes in Dysphagia Classification
To measure the changes in Dysphagia classification it was used the Fiberoptic Endoscopic Evaluation of Swallowing, exam that evaluate the functionability of swallow. These exams were presented to three judges (speech therapists) that in agreement classified the degree of dysphagia
Changes in Speech Intelligibility Classification
To measure the changes in Speech Intelligibility it was used speech recordings that were analysed by three judges (speech therapists) that in agreement classified the degree of speech intelligibility

Full Information

First Posted
October 11, 2019
Last Updated
October 11, 2019
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT04126226
Brief Title
Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy
Official Title
Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to verify the impact of four speech therapy sessions on the Quality of Life of patients treated for malignant tongue and/or jaw cancer, using as measure specific questionnaires of speech and swallowing. The hypothesis is that after treatment with exercises and speech therapy guidance, patients will present better indicators on Quality of Life related to speech and swallowing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tongue Cancer, Jaw Cancer, Oral Cancer, Intelligibility, Speech
Keywords
Speech therapy, Dysphagia, Speech Intelligibility, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Speech-language guidance
Intervention Description
Speech-language guidance for speech enhancement and on food management in terms of consistency, volumes, utensils and temperature, beyond the care for safe and efficient swallowing.
Intervention Type
Other
Intervention Name(s)
Speech therapy exercises for swallowing
Intervention Description
Use of lip exercises and facial muscles, laryngeal elevation maneuver and airway protection technique, 5 repetitions 3 times a day for a month.
Intervention Type
Other
Intervention Name(s)
Speech therapy exercises for speech
Intervention Description
Use of over-articulation technique and glottal firmness exercise, 5 repetitions 3 times a day for a month.
Primary Outcome Measure Information:
Title
Changes in Quality of Life Scores related to swallowing
Description
To measure the changes in Quality of Life related to swallowing it was used the questionnaire Dysphagia Handicap Index (DHI)
Time Frame
1 month
Title
Changes in Quality of Life Scores related to speech
Description
To measure the changes in Quality of Life related to speech it was used the questionnaire Speech Handicap Index (SHI)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Changes in Dysphagia Classification
Description
To measure the changes in Dysphagia classification it was used the Fiberoptic Endoscopic Evaluation of Swallowing, exam that evaluate the functionability of swallow. These exams were presented to three judges (speech therapists) that in agreement classified the degree of dysphagia
Time Frame
1 month
Title
Changes in Speech Intelligibility Classification
Description
To measure the changes in Speech Intelligibility it was used speech recordings that were analysed by three judges (speech therapists) that in agreement classified the degree of speech intelligibility
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 Years Tongue and/or Jaw Neoplasm Submitted to surgical treatment Exclusion Criteria: Under 18 Years Cognitive impairment or deficits in language comprehension Previous speech therapy intervention Recurrence or active disease Death during the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sady S da Costa, PHD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90.035-903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy

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