NCT05621889 Innovative Patient-partner-guided Virtual Group Speech Pathology Intervention Model in Head and Neck Cancer
| NCT ID | NCT05621889 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Dysphagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2023-06-02 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 76 participants in total. It began in 2023-06-02 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05621889 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05621889 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05621889 currently recruiting?
Yes, NCT05621889 is actively recruiting participants. Contact the research team at marie-eve.caty@uqtr.ca for enrollment information.
Where is the NCT05621889 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05621889 clinical trial?
NCT05621889 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 76 participants.