search
Back to results

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

Primary Purpose

ORL Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient managed at the IUCT-O and by a private speech therapist (near the patient's home).
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for ORL Cancer focused on measuring Video-Assisted Speech Therapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Age ≥ 18 years at study entry.
  2. Patient with T3-T4 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).

Sites / Locations

  • Institut Universitaire du Cancer de Toulouse - OncopoleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with T3-T4 ORL cancer, relevant to surgery and/or radiotherapy and/or chemotherapy.

Arm Description

Outcomes

Primary Outcome Measures

The rate of patients for whom tele-therapy will be considered successful.

Secondary Outcome Measures

The rate of patients with full or partial resolution of speech-language pathology at the end of the telecare consultation.

Full Information

First Posted
June 17, 2021
Last Updated
June 2, 2023
Sponsor
Institut Claudius Regaud
search

1. Study Identification

Unique Protocol Identification Number
NCT04940000
Brief Title
Evaluation of the Interest of a Video-assisted Remote Speech Therapy Consultation in Patients With ORL Cancer (TELE ORTHOPHONIE)
Official Title
Evaluation of the Interest of a Video-assisted Remote Speech Therapy Consultation in Patients With ORL Cancer (TELE ORTHOPHONIE)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
September 2028 (Anticipated)
Study Completion Date
September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ORL Cancer
Keywords
Video-Assisted Speech Therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with T3-T4 ORL cancer, relevant to surgery and/or radiotherapy and/or chemotherapy.
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Patient managed at the IUCT-O and by a private speech therapist (near the patient's home).
Intervention Description
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.
Primary Outcome Measure Information:
Title
The rate of patients for whom tele-therapy will be considered successful.
Time Frame
12 months for each patient
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years at study entry. Patient with carcinological pathology of the VADS, relevant to surgery and/or radiotherapy and/or chemotherapy. Patient managed at the IUCT-O and by a private speech therapist (near the patient's home). Patient affiliated to a Social Security system in France. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure. Exclusion Criteria: Pregnant or lactating women. 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. Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jérôme SARINI
Phone
05 31 15 60 16
Email
sarini.jerome@iuct-oncopole.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Claude FARENC
Phone
05 31 15 51 97
Email
farenc.jean-claude@iuct-oncopole.fr
Facility Information:
Facility Name
Institut Universitaire du Cancer de Toulouse - Oncopole
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme SARINI
Phone
05 31 15 60 16
Email
sarini.jerome@iuct-oncopole.fr
First Name & Middle Initial & Last Name & Degree
Jean-Claude FARENC
Phone
05 31 15 51 97
Email
farenc.jean-claude@iuct-oncopole.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs