Innovative Patient-partner-guided Virtual Group Speech Pathology Intervention Model in Head and Neck Cancer
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
1 other identifier
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2023
Typical duration for phase_1
1 active site
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
First Submitted
Initial submission to the registry
November 11, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedStudy Start
First participant enrolled
June 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMarch 21, 2025
March 1, 2025
2.6 years
November 11, 2022
March 18, 2025
Conditions
Outcome Measures
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.
within 6 weeks post radiation
Study Arms (1)
virtual group speech therapy intervention guided by a patient partner
EXPERIMENTALInterventions
virtual group speech therapy intervention guided by a patient partner
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2x 3E4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2022
First Posted
November 18, 2022
Study Start
June 2, 2023
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
March 21, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share