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

Condition(s) studied

Investigational drug(s) / intervention(s)

ESSI-SURG: Patients will receive 3 face-to-face sessions with a speech-language pathologist (SLP), each with a specific goal, namely: pre-surgical educational, a post-operative day 3 therapy, and post-operative day 7 therapy. Following discharge from hospital, participants will be seen by an SLP for 4 weekly sessions, offered via telehealth or face-to-face depending on the patient's clinic schedule and/or availability.

Standard-of-Care: Participants 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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%.
• 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.

Trial sites (1)

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