Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer
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
- 否
入选标准
- •Age between 18 and 85 years old
- •Patient diagnosed with an head and neck squamous-cell carcinoma, stage T2-T4/N+, non-metastatic, localised at larynx, pharynx, oropharynx, oral cavity or maxillary, needing curative surgery, with indication of radiotherapy after surgery, in accordance to decision of the regular multidisciplinary meetings in cancerology
- •No ongoing measure of corrective justice for the patient
- •Informed consent form signed
- •Patient covered by health system
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
研究组 & 干预措施
Accompanying caregivers by paramedical team
干预措施: Accompanying caregivers by paramedical team (Other)
No dedicated accompanying by medical team
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
- Measure of quality of life in the two groups(between 16 and 20 weeks after surgery)
- Comparison of the impact of paramedical care on the caregiving burden between the two groups(At 12 weeks after surgery)
- Comparison of the impact of paramedical care on the caregiving burden between the two groups(At 8 weeks after surgery)
- Measure of quality of life in the two groups(baseline)
- Measure of quality of life in the two groups(one week after hospital discharge)
- Measure of quality of life in the two groups(between 4 and 8 weeks after surgery)
- Measure of quality of life in the two groups(between 8 and 12 weeks after surgery)