Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients who are planned for total glossectomy
Trial design
Design model
Parallel
Treatments tested in this trial
ESSI-SURG
BehavioralPatients 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
BehavioralParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Arm 1 - ControlActive comparator 1 intervention
Group B: Arm 2 - InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Study feasibility as measured by rate of accrual
Feasibility success will be defined as the following across all patients and compared by arm: an accrual rate \>90%.
Time frame
Baseline to Post-Discharge Week 52
Study feasibility as measured by attrition
Feasibility success will be defined as the following across all patients and compared by arm: an attrition rate of \<10%.
Time frame
Baseline to Post-Discharge Week 53
Study feasibility as measured by data fidelity for clinician assessments
Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of \>80% for clinical assessments.
Time frame
Baseline to Post-Discharge Week 54
Study feasibility as measured by data fidelity for patient-reported outcomes
Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of \>90% for patient reported outcomes.
Time frame
Baseline to Post-Discharge Week 5Sponsors and contacts
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Source ClinicalTrials.gov