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Trial Title:
Innovative Patient-partner-guided Virtual Group Speech Pathology Intervention Model in Head and Neck Cancer
NCT ID:
NCT05621889
Condition:
Dysphagia
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
virtual group speech therapy intervention guided by a patient partner
Description:
virtual group speech therapy intervention guided by a patient partner
Arm group label:
virtual group speech therapy intervention guided by a patient partner
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier de l'Université de Montréal
Address:
City:
Montréal
Zip:
H2x 3E4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Mom Phat
Email:
mom.phat.chum@ssss.gouv.qc.ca
Contact backup:
Last name:
Silvine Benth
Email:
mom.phat.chum@ssss.gouv.qc.ca
Investigator:
Last name:
Edith Filion, MD
Email:
Principal Investigator
Investigator:
Last name:
Houda Bahig, MD PhD
Email:
Sub-Investigator
Start date:
June 2, 2023
Completion date:
January 2026
Lead sponsor:
Agency:
Centre hospitalier de l'Université de Montréal (CHUM)
Agency class:
Other
Collaborator:
Agency:
Université du Québec à Trois-Rivières
Agency class:
Other
Source:
Centre hospitalier de l'Université de Montréal (CHUM)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05621889
