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

NCT06192771 | Recruiting

• 1 other identifier: 23-5503
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Head and Neck Cancer

Keywords

dysphagia; head and neck cancer; speech language pathology; surgery; speech; early intervention; medical outcomes

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Behavioral: Standard-of-Care

Arm 2 - Intervention

EXPERIMENTAL

Participants in this Arm will receive the ESSI-SURG behavioural intervention by a live SLP.

Behavioral: ESSI-SURG

Interventions

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.

Arm 2 - Intervention

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.

Arm 1 - Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who are planned for total glossectomy

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2C4, Canada

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Head and Neck Neoplasms; Speech

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neoplasms by Site; Neoplasms; Verbal Behavior; Communication; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rosemary Martino, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Jonathan Irish, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trixie Reichardt, MHSc

CONTACT

416-946-3826; trixie.reichardt@uhnresearch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 5, 2024
• Study Start: December 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-01

Locations

CA (1)