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Clinical Trials/NCT04940000
NCT04940000
Recruiting
Not Applicable

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

Institut Claudius Regaud1 site in 1 country105 target enrollmentSeptember 2, 2021
ConditionsORL Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ORL Cancer
Sponsor
Institut Claudius Regaud
Enrollment
105
Locations
1
Primary Endpoint
The rate of patients for whom tele-therapy will be considered successful.
Status
Recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2, 2021
End Date
September 1, 2028
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

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

Time Frame: 12 months for each patient

Secondary Outcomes

  • 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)

Study Sites (1)

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