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RecruitingNCT05621889Updated Mar 21, 2025

Innovative Patient-partner-guided Virtual Group Speech Pathology Intervention Model in Head and Neck Cancer

A Phase 1/2 interventional study of virtual group speech therapy intervention guided by a patient partner in Dysphagia, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
76
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This project aims to study an innovative intervention, the eG2 Intervention, developed by speech-language pathologists at the Centre hospitalier de l'Université de Montréal to improve therapeutic adherence and prevent dysphagia in patients treated with chemoradiotherapy for head and neck cancer.

The innovation consists in offering a speech therapy intervention that is 1) virtual, 2) group-based (whereas it is usually individual) and 3) involves a patient partner. This intervention has the potential to improve quality of care, accessibility to services and optimize health care resources.

02

Conditions studied

  • Dysphagia
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 76 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults ≥ 18 years of age with a diagnosis of head or neck cancer
  • Chemoradiotherapy treatments planned for curative purposes
  • Planned external radiation therapy dose of at least ≥60 Grays
  • Sufficient proficiency in French to complete self-reported questionnaires

Exclusion criteria

Exclusion Criteria:

  • Remote metastases
  • Previous or planned total laryngectomy
  • Previous moderate/severe dysphagia known and/or evaluated by speech therapy
  • Diagnosis of a second synchronous cancer at the time of study enrollment
  • History of prior radiation therapy to the head and neck area
  • Have a cognitive impairment (diagnosed or suspected) that may significantly interfere with participation in the intervention and various measurement procedures.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    virtual group speech therapy intervention guided by a patient partner

    Procedure: virtual group speech therapy intervention guided by a patient partner

Interventions

  • Procedurevirtual group speech therapy intervention guided by a patient partner

    virtual group speech therapy intervention guided by a patient partner

06

What researchers measure

Primary outcomes

  1. Rate of nasogastric tube

    To evaluate the rate of nasogastric tube placement in the acute and subacute period in patients who participated in the group intervention.

    Time frame: within 6 weeks post radiation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05621889
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Université du Québec à Trois-Rivières
Responsible party
Sponsor
First posted
Nov 18, 2022
Start date
Jun 2, 2023
Primary completion
Jan 2026 (estimated)
Completion
Jan 2026 (estimated)
Last update
Mar 21, 2025

Study contacts

Marie-Eve Caty, M.P.O., Ph.D.
Contact
marie-eve.caty@uqtr.ca
819 376-5011 ext. 3261
Houda Bahig, MD PhD
Contact
houda.bahig.med@ssss.gouv.qc.ca
514-890-8254

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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