Идёт набор NCT06192771

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

Без фазы С лечением Dysphagia Head and Neck Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: ESSI-SURG, Standard-of-Care.
Кому может быть актуально: Состояния в реестре: Dysphagia, Head and Neck Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

Поведенческое 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.
Поведенческое 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.

Первичные конечные точки

Study feasibility as measured by rate of accrual [Срок оценки: Baseline to Post-Discharge Week 5]
Study feasibility as measured by attrition [Срок оценки: Baseline to Post-Discharge Week 5]
Study feasibility as measured by data fidelity for clinician assessments [Срок оценки: Baseline to Post-Discharge Week 5]
Study feasibility as measured by data fidelity for patient-reported outcomes [Срок оценки: Baseline to Post-Discharge Week 5]

Критерии участия

Критерии включения

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