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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Control | Active Comparator | 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. |
|
| Arm 2 - Intervention | Experimental | Participants in this Arm will receive the ESSI-SURG behavioural intervention by a live SLP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESSI-SURG | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Baseline to Post-Discharge Week 5 |
| 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%. | Baseline to Post-Discharge Week 5 |
| 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. | Baseline to Post-Discharge Week 5 |
| 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. | Baseline to Post-Discharge Week 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trixie Reichardt, MHSc | Contact | 416-946-3826 | trixie.reichardt@uhnresearch.ca |
| Name | Affiliation | Role |
|---|---|---|
| Rosemary Martino, PhD | University Health Network, Toronto | Principal Investigator |
| Jonathan Irish, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Recruiting | Toronto | Ontario | M5G2C4 | Canada |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D006258 | Head and Neck Neoplasms |
| D013060 | Speech |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard-of-Care | Behavioral | 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. |
|
| D010038 | Otorhinolaryngologic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |