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NCT05621889 Clinical Trial

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

Dysphagia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05621889
Other study ID # 2023-11195
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date June 2, 2023
Est. completion date January 2026

Study information
Verified date June 2023
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 76
Est. completion date January 2026
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Centre Hospitalier de l'Université de Montréal Montréal Quebec

Sponsors (2)
Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM) Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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