Dysphagia, Head and Neck Cancer
Conditions
Keywords
dysphagia, head and neck cancer, speech language pathology, surgery, speech, early intervention, medical outcomes
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.
Interventions
BEHAVIORALESSI-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.
BEHAVIORALStandard-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.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* Patients who are planned for total glossectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Contacts
CONTACTTrixie Reichardt, MHSc
PRINCIPAL_INVESTIGATORRosemary Martino, PhD
University Health Network, Toronto
PRINCIPAL_INVESTIGATORJonathan Irish, MD
University Health Network, Toronto
Outcome results
None listed