Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically
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
- 否
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
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
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
Rosemary Martino, PhD
Principal Investigator
University Health Network, Toronto
