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Clinical Trials/NCT05621889
NCT05621889RecruitingPhase 1

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

Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country76 target enrollmentStarted: June 2, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Sponsor
Enrollment
76
Locations
1
Primary Endpoint
Rate of nasogastric tube

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

virtual group speech therapy intervention guided by a patient partner

Experimental

Intervention: virtual group speech therapy intervention guided by a patient partner (Procedure)

Outcomes

Primary Outcomes

Rate of nasogastric tube

Time Frame: within 6 weeks post radiation

To evaluate the rate of nasogastric tube placement in the acute and subacute period in patients who participated in the group intervention.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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