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NCT Number: NCT05621889

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

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.

Recruiting

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2x 3E4, Canada

Location status: Recruiting

Location contact

Edith Filion, MD

PRINCIPAL_INVESTIGATOR

Houda Bahig, MD PhD

SUB_INVESTIGATOR

Mom Phat

CONTACT

[email protected]

Silvine Benth

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

virtual group speech therapy intervention guided by a patient partner

Procedure

virtual group speech therapy intervention guided by a patient partner

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Houda Bahig, MD PhD

CONTACT

[email protected]

514-890-8254

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

CONTACT

[email protected]

819 376-5011 ext. 3261

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Université du Québec à Trois-Rivières

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2022
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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