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临床试验/NCT06192771
NCT06192771招募中不适用

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

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Study feasibility as measured by data fidelity for clinician assessments

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients who are planned for total glossectomy

研究组 & 干预措施

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.

干预措施: Standard-of-Care (Behavioral)

Arm 2 - Intervention

Experimental

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

干预措施: ESSI-SURG (Behavioral)

结局指标

主要结局

Study feasibility as measured by data fidelity for clinician assessments

时间窗: 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

时间窗: 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.

Study feasibility as measured by rate of accrual

时间窗: 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

时间窗: 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%.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosemary Martino, PhD

Principal Investigator

University Health Network, Toronto

研究点 (2)

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