Evaluation of the Interest of a Video-assisted Remote Speech Therapy Consultation in Patients With ORL Cancer (TELE ORTHOPHONIE)

July 28, 2025 updated by: Institut Claudius Regaud

Interventional, prospective, single-centre study aimed to evaluate the impact of a video-assisted remote speech therapy consultation in relation to the complexity and specificity of the care of patients with ORL cancer. Three indications will be studied: phonation problems, swallowing problems and other problems.

The study will be conducted on a population of patients with T3, T4 ORL cancer requiring speech therapy.

Each patient included will have a video-assisted speech therapy consultation with a private speech therapist and an expert speech therapist. At the end of this video consultation, the patient and the private speech therapist will be asked to complete a satisfaction questionnaire.

At the follow-up visit following the video-assisted consultation, the patient will have completed participation in the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years at study entry.
  2. Patient with carcinological pathology of the VADS, relevant to surgery and/or radiotherapy and/or chemotherapy.
  3. Patient managed at the IUCT-O and by a private speech therapist (near the patient's home).
  4. Patient affiliated to a Social Security system in France.
  5. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure.

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Any psychological, familial, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures foreseen in the study protocol.
  3. Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with T3-T4 ORL cancer, relevant to surgery and/or radiotherapy and/or chemotherapy.
Other: Patient managed at the IUCT-O and by a private speech therapist (near the patient's home).

Each patient included will have a video-assisted remote speech therapy consultation with a private speech therapist (near the patient's home) and the expert speech therapist of IUCT-O center.

At the end of this video consultation, the patient and the private speech therapist will be asked to complete a satisfaction questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of patients for whom tele-therapy will be considered successful.
Time Frame: 12 months for each patient
12 months for each patient

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate of patients with full or partial resolution of speech-language pathology at the end of the telecare consultation.
Time Frame: 12 months for each patient
12 months for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2021

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 25, 2021

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21VADS03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ORL Cancer

Clinical Trials on Patient managed at the IUCT-O and by a private speech therapist (near the patient's home).

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe