跳至主要内容
临床试验/NCT04569500
NCT04569500招募中不适用

FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS' AND THEIR FAMILY CAREGIVER'S QUALITY OF LIFE

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2021年9月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
264
试验地点
1
主要终点
Quality of life score (PSS-HN scale) of patients with total laryngectomy

研究概览

简要总结

The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology (Pérol2007), in particular for cancers of the upper aerodigestive tract (Allison2010). In the case of pharyngeal and laryngeal cancer, total laryngectomy associated with radiotherapy remains a reference treatment for advanced stage cancers. This mutilating surgical procedure has a major impact on the patient's life, due to its physical and functional sequelae: phonatory (loss of physiological voice), feeding, olfactory and aesthetic (tracheostomy). Its psychosocial consequences are also important, owing to the biographical disruption and the identity-related metamorphoses associated with illness and its treatment, which alter the quality of life not only of patients, but also of their close relations. Indeed, transformation is not only at individual level, it also impacts the life of close relations, in particular spouses, who share the day-to-day lives of patients (Babin 2010). Currently, care for laryngectomized patients consist essentially in informing and educating them on certain technical procedures (cannula replacement, mucosity aspiration, tracheostomy or phonatory implant cleaning) during hospital admission. Such education may be formalized and dispensed within the context of a therapeutic education program.

The issue of this study will be to determine what therapeutic education program we should offer patients and their close relations in order to accompany them throughout their experience of laryngectomy and to reduce its impact on social and professional aspects of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Quality of life score (PSS-HN scale) of patients with total laryngectomy

时间窗: 12 months

Difference in gain observed at six months in the mean quality of life score (PSS-HN scale) of patients with total laryngectomy and their close relatives, having benefited from the PTE program and those having benefited from usual care.

次要结局

  • Quality of life score (EVA scale) of patient's close relatives(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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