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

NCT ID: NCT05621889

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-02

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dysphagia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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virtual group speech therapy intervention guided by a patient partner

Group Type EXPERIMENTAL

virtual group speech therapy intervention guided by a patient partner

Intervention Type PROCEDURE

virtual group speech therapy intervention guided by a patient partner

Interventions

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virtual group speech therapy intervention guided by a patient partner

virtual group speech therapy intervention guided by a patient partner

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université du Québec à Trois-Rivières

OTHER

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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

Role: CONTACT

819 376-5011 ext. 3261

Houda Bahig, MD PhD

Role: CONTACT

514-890-8254

Facility Contacts

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Mom Phat

Role: primary

Silvine Benth

Role: backup

Other Identifiers

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2023-11195

Identifier Type: -

Identifier Source: org_study_id

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