跳至主要内容
临床试验/NCT05542706
NCT05542706招募中不适用

Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer

Centre Henri Becquerel1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年10月31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
76
试验地点
1
主要终点
Comparison of the impact of paramedical care on the caregiving burden between the two groups

研究概览

简要总结

Head and Neck invasive cancer usually requires surgery that is associated with modifications of the body structure of patient regarding breathing, eating and communication. These modifications are correlated with an important loss of autonomy in patients. During the study, while the patient is hospitalised after the surgery, the paramedical team will train the caregiver of the patient from experimental group a new dimension of autonomy in order to assure a safe return home. The level of learning depends on each caregiver and patient; therefore, an adapted training is provided.

This study evaluates the impact of paramedical care in accompanying caregivers of patients that had surgery for an ENT invasive cancer, by comparing the experimental group (paramedical care) to the standard group (standard care).

The hypothesis of the study is that a benefit will be seen in the experimental group, by reducing the caregiver burden, improving the quality of life of patients and lowering the rate of hospitalisations and prolonged hospitalisations in these patients.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patient scheduled for surgery after radiotherapy or for surgery on site already irradiated
  • Patient or caregiver that do not agree to participate in the study (the pair patient-caregiver is needed)
  • History of psychological or sensorial disorder or anomaly that can prevent the patient from understanding the conditions for study participation

结局指标

主要结局

Comparison of the impact of paramedical care on the caregiving burden between the two groups

时间窗: At 20 weeks after surgery

Via Zarit Burden Interview

次要结局

  • Comparison of the impact of paramedical care on the caregiving burden between the two groups(At 12 weeks after surgery)
  • Measure of quality of life in the two groups(between 16 and 20 weeks after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验