ORL CancerNCT04940000
Evaluation of the Interest of a Video-assisted Remote Speech Therapy Consultation in Patients With ORL Cancer (TELE ORTHOPHONIE)
A study testing Patient managed at the IUCT-O and by a private speech therapist (near the patient's home). in people with ORL Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ORL Cancer
- What is being tested?
- Patient managed at the IUCT-O and by a private speech therapist (near the patient's home).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2021to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse
Jérôme SARINI, 05 31 15 60 16, sarini.jerome@iuct-oncopole.fr
Jean-Claude FARENC, 05 31 15 51 97, farenc.jean-claude@iuct-oncopole.fr
About this study
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.
Read more
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.
- Conditions
- ORL Cancer
- Being tested
- Patient managed at the IUCT-O and by a private speech therapist (near the patient's home).
- Keywords
- Video-Assisted Speech Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient managed at the IUCT-O and by a private speech therapist (near the patient's home).Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient with T3-T4 ORL cancer, relevant to surgery and/or radiotherapy and/or chemotherapy. | Experimental | Not described Receives: Other: Patient managed at the IUCT-O and by a private speech therapist (near the patient's home). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients for whom tele-therapy will be considered successful.
Measured: 12 months for each patient
Secondary outcomes (1)
The rate of patients with full or partial resolution of speech-language pathology at the end of the telecare consultation.
Measured: 12 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start2 Sep 2021
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ORL CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940000
- Sponsor's protocol ID
- 21VADS03
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2021
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interest of a Video-assisted Remote Speech Therapy Consultation in Patients With ORL Cancer (TELE ORTHOPHONIE)
- ClinicalTrials.gov ID
- NCT04940000
- Acronym / sponsor ID
- 21VADS03
- Conditions
- ORL Cancer
- Keywords
- Video-Assisted Speech Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with T3-T4 ORL cancer, relevant to surgery and/or radiotherapy and/or chemotherapy. | Experimental | Other: Patient managed at the IUCT-O and by a private speech therapist (near the patient's home). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patient with T3-T4 ORL cancer, relevant to surgery and/or radiotherapy and/or chemotherapy. |
Primary outcome
The rate of patients for whom tele-therapy will be considered successful.
Time frame: 12 months for each patient
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient managed at the IUCT-O and by a private speech therapist (near the patient's home). in people with ORL Cancer, run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jérôme SARINI (05 31 15 60 16, sarini.jerome@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients for whom tele-therapy will be considered successful. (time frame: 12 months for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.