Recruiting
Phase 1
Phase 2

Speech Pathology Intervention

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05621889

Conditions

Dysphagia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

virtual group speech therapy intervention guided by a patient partner

Study Details

Brief 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.

Conditions

Dysphagia

Study ID

NCT05621889

Start date

Jun 2, 2023

Status verified date

Mar, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

  • 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.

Study Design

Enrollment

76 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

virtual group speech therapy intervention guided by a patient partner

virtual group speech therapy intervention guided by a patient partner

Primary outcome measure

  • Rate of nasogastric tube [ Time Frame: within 6 weeks post radiation ]

Central Contacts and Locations

Central contacts

Marie-Eve Caty, M.P.O., Ph.D.

819 376-5011marie-eve.caty@uqtr.ca

Houda Bahig, MD PhD

514-890-8254houda.bahig.med@ssss.gouv.qc.ca

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montréal, Quebec, Canada, H2x 3E4

Contacts

Mom Phat

mom.phat.chum@ssss.gouv.qc.ca

Silvine Benth

mom.phat.chum@ssss.gouv.qc.ca

Principal Investigator:

Edith Filion, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Mar 21, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-03-21.