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

Primary Purpose

Dysphagia

Status
Active
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
virtual group speech therapy intervention guided by a patient partner
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

virtual group speech therapy intervention guided by a patient partner

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2022
Last Updated
June 1, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Université du Québec à Trois-Rivières
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1. Study Identification

Unique Protocol Identification Number
NCT05621889
Brief Title
Innovative Patient-partner-guided Virtual Group Speech Pathology Intervention Model in Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Université du Québec à Trois-Rivières

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
virtual group speech therapy intervention guided by a patient partner
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
virtual group speech therapy intervention guided by a patient partner
Intervention Description
virtual group speech therapy intervention guided by a patient partner
Primary Outcome Measure Information:
Title
Rate of nasogastric tube
Description
To evaluate the rate of nasogastric tube placement in the acute and subacute period in patients who participated in the group intervention.
Time Frame
within 6 weeks post radiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2x 3E4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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