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

Not Applicable

Recruiting

• Conditions: ORL Cancer
• Interventions: Other: Patient managed at the IUCT-O and by a private speech therapist (near the patient's home).

• Registration Number: NCT04940000
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-25
• Study Start: 2021-09-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Primary Completion: 2028-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with T3-T4 ORL cancer, 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).	-

Primary Outcome Measures

Name	Time	Method
The rate of patients for whom tele-therapy will be considered successful.	12 months for each patient

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Universitaire du Cancer de Toulouse - Oncopole; 🇫🇷 Toulouse, France