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Recruiting NCT05621889

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

Phase I / Phase II Interventional Dysphagia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: virtual group speech therapy intervention guided by a patient partner.
Who it may be relevant to
Registry conditions: Dysphagia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impacts of an Innovative Patient-partner-guided Virtual Group Speech Pathology Intervention Model to Prevent Swallowing Disorders in Patients Treated With Chemoradiotherapy for Head and Neck Cancer

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Centre Hospitalier de l'Université de Montréal — Montreal

Identifiers

NCT: NCT05621889 · 2023-11195

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗