NCT04940000

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Sep 2021Sep 2028

First Submitted

Initial submission to the registry

June 17, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 2, 2021

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

7 years

First QC Date

June 17, 2021

Last Update Submit

July 28, 2025

Conditions

Keywords

Video-Assisted Speech Therapy

Outcome Measures

Primary Outcomes (1)

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

    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.

    12 months for each patient

Study Arms (1)

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).

Interventions

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 25, 2021

Study Start

September 2, 2021

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

July 31, 2025

Record last verified: 2025-07

Locations