Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically

Not Applicable

Recruiting

• Conditions: Dysphagia; Head and Neck Cancer
• Interventions: Behavioral: ESSI-SURG; Behavioral: Standard-of-Care

• Registration Number: NCT06192771
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Oral cavity cancer (OCC) is one of the most common cancers worldwide, with tongue cancer being one of the most common subtypes. Patients with oral cancers can experience painful swallowing, swallowing difficulty (dysphagia), and associated weight loss long after surgery. Not only is dysphagia an independent predictor of quality of life (QoL) in cancer survivorship, it can also have a devastating impact on the health of patients resulting from complications such as pneumonia, malnutrition and feeding tube dependence. Emerging evidence suggests that patients undergoing surgery benefit from engaging with speech-language pathologists (SLPs) before problems arise, to learn swallow strategies that may become useful in their rehabilitation. This in turn has the potential to reduce complications and minimize the length of feeding tube dependency.

This study will assess the feasibility of conducting a prospective clinical trial that would evaluate the effects on patient health, function and overall benefit of early and systematic SLP speech and swallowing intervention for head and neck cancer patients planned for curative surgical treatment. We will also assess long-term changes in select clinical and patient-reported outcomes comparing their status before, and one month after, treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-01
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Newly diagnosed patients with at least T2 stage tongue SCC who are planned for partial glossectomy and free flap reconstruction and are anticipated to achieve a post-operative independent oral intake.
• Proficient in spoken and written English

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Exclusion Criteria

• Patients who are planned for total glossectomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 - Intervention	ESSI-SURG	Participants in this Arm will receive the ESSI-SURG behavioural intervention by a live SLP.
Arm 1 - Control	Standard-of-Care	Participants in this Arm will receive the current standard of care, which includes a referral to SLP in response to suspicion of a swallowing problem from either assessment by the medical team and/or patient report.

Primary Outcome Measures

Name	Time	Method
Study feasibility as measured by attrition	Baseline to Post-Discharge Week 5	Feasibility success will be defined as the following across all patients and compared by arm: an attrition rate of \<10%.
Study feasibility as measured by data fidelity for clinician assessments	Baseline to Post-Discharge Week 5	Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of \>80% for clinical assessments.
Study feasibility as measured by data fidelity for patient-reported outcomes	Baseline to Post-Discharge Week 5	Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of \>90% for patient reported outcomes.
Study feasibility as measured by rate of accrual	Baseline to Post-Discharge Week 5	Feasibility success will be defined as the following across all patients and compared by arm: an accrual rate \>90%.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada