Assessment and Prevention of Caregiver Burden in Oncology
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 10
- 主要终点
- Caregiver burden
研究概览
简要总结
The goal of this randomized, open and controlled supportive care study is to see if we can reduce the burden on the caregiver by offering the caregiver systematic and regular support from the nurse (APN, nurse coordinator in French health care organisations) compared to a support focused on the patient. At the same time, we will also evaluate the impact of this personalised support for the caregiver on their anxiety and quality of life.
Participants will caregivers of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month.
Researchers will compare 2 groups : a group where caregivers benefit from specific nursing support and a group of caregivers with no specific nursing support.
The specific support includes 3 mandatory on-site nursing consultations with the patient's caregiver and interviews once a month with a nurse either by phone, on-site consultation or teleconsultation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregiver designated by the patient;
- •Caregiver of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month;
- •Caregiver of patient already cared for by a nurse before inclusion or going to start a nursing follow-up;
- •Caregiver of a patient with a score ≥2 of social fragility and/or psychological fragility and/or nutritional fragility and/or complexity;
排除标准
- •Patient whose life expectancy is assumed to be < 6 months;
- •Patient living in an institution (EHPAD, MAS, SSR, MCO, USLD) at inclusion;
- •Caregiver declared as having a pathology that could alter his/her capacity to support (psychiatric history, dementia...) or under guardianship.
结局指标
主要结局
Caregiver burden
时间窗: at 6 months post-randomisation
Comparison in the 2 groups. Burden score is assessed using the ZARIT SCALE. The test consists of 22 questions that the caregiver has to score from 0 to 4, the whole giving a score from 0 to 88. 0 means no burden, 88 means that the burden is severe
次要结局
- Caregiver's quality of life(at month 6 (M6) and month 12 (M12) post-randomisation.)
- Caregiver's satisfaction(at month 6 (M6) and month 12 (M12) post-randomisation.)
- The level of anxiety/depression of the caregiver(at month 6 (M6) and month 12 (M12) post-randomisation.)