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

Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Oral Cancer; Intelligibility, Speech; Tongue Cancer; Jaw Cancer
• Intervention / Treatment: Other: Speech-language guidance; Other: Speech therapy exercises for swallowing; Other: Speech therapy exercises for speech

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90.035-903
      • Hospital de Clínicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Study group	Other: Speech-language guidance; 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.; Other: Speech therapy exercises for swallowing; Use of lip exercises and facial muscles, laryngeal elevation maneuver and airway protection technique, 5 repetitions 3 times a day for a month.; Other: Speech therapy exercises for speech; Use of over-articulation technique and glottal firmness exercise, 5 repetitions 3 times a day for a month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 month
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)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month
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	1 month

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Study Director: Sady S da Costa, PHD, Hospital de Clínicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Quality of Life; Dysphagia; Speech therapy; Speech Intelligibility
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Neurobehavioral Manifestations; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Neurodevelopmental Disorders; Tongue Diseases; Mouth Neoplasms; Tongue Neoplasms; Communication Disorders
• Other Study ID Numbers: 96487218300005327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No