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临床试验/NCT05621889
NCT05621889招募中1 期

Impacts of an Innovative Patient-partner-guided Virtual Group Speech Pathology Intervention Model to Prevent Swallowing Disorders in Patients Treated With Chemoradiotherapy for Head and Neck Cancer

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年6月2日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
76
试验地点
1
主要终点
Rate of nasogastric tube

研究概览

简要总结

This project aims to study an innovative intervention, the eG2 Intervention, developed by speech-language pathologists at the Centre hospitalier de l'Université de Montréal to improve therapeutic adherence and prevent dysphagia in patients treated with chemoradiotherapy for head and neck cancer.

The innovation consists in offering a speech therapy intervention that is 1) virtual, 2) group-based (whereas it is usually individual) and 3) involves a patient partner. This intervention has the potential to improve quality of care, accessibility to services and optimize health care resources.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • •Adults ≥ 18 years of age with a diagnosis of head or neck cancer
  • •Chemoradiotherapy treatments planned for curative purposes
  • •Planned external radiation therapy dose of at least ≥60 Grays
  • •Sufficient proficiency in French to complete self-reported questionnaires

排除标准

  • •Remote metastases
  • •Previous or planned total laryngectomy
  • •Previous moderate/severe dysphagia known and/or evaluated by speech therapy
  • •Diagnosis of a second synchronous cancer at the time of study enrollment
  • •History of prior radiation therapy to the head and neck area
  • •Have a cognitive impairment (diagnosed or suspected) that may significantly interfere with participation in the intervention and various measurement procedures.

研究组 & 干预措施

virtual group speech therapy intervention guided by a patient partner

Experimental

干预措施: virtual group speech therapy intervention guided by a patient partner (Procedure)

结局指标

主要结局

Rate of nasogastric tube

时间窗: within 6 weeks post radiation

To evaluate the rate of nasogastric tube placement in the acute and subacute period in patients who participated in the group intervention.

次要结局

未报告次要终点

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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