Coaching for Coping in Glioblastoma Patients and Caregivers and Its Association With Compliance to TTFields
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 275
- 主要终点
- EFFICACY of intervention
研究概览
简要总结
The aim is to improve patients' compliance to TTFields therapy by a psychological video intervention in a multi-center, randomized controlled trial.
详细描述
Patients diagnosed with a glioblastoma and their family caregivers are mainly impaired by the poor prognosis and the high symptom burden. Caregivers report impaired health-related quality of life (HRQOL) and high distress. They even may experience significantly higher levels of anxiety and depression than patients themselves . Furthermore, Boele et al. showed that the overall survival in glioblastoma patients is associated with family caregivers' mastery.
In newly diagnosed glioblastoma, the EF-14 RCT demonstrated significantly prolonged survival in patients treated with TTFields compared to controls, with a median overall survival (OS) of 20.9 vs 16.0 months.
Several studies showed an important association of the daily compliance rate with OS and progression-free survival (PFS). Family caregivers' support might be associated to the patients' compliance and adequate support is required. However, so far rare supportive programs for patients and their caregivers have been established. It has been shown that delivery of supportive care via telehealth is feasible, however studies examining the effectiveness, adoption and maintenance of telehealth interventions in glioblastoma patients and family caregivers are still lacking. The aim is to improve patients' compliance to TTFields therapy by a psychological video intervention.
It is a multi-center, randomized controlled trial.
Main inclusion criteria are:
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
- 是
入选标准
- •Ability to understand and give an informed consent, capacity to consent
- •Given informed consent
- •≥ 18 years of age
- •Patients with newly diagnosed glioblastoma
- •Patients with IDH-mutant Astrocytoma, CNS WHO-Grade 4, newly diagnosed (by biopsy or incomplete tumor resection)
- •Patients eligible for radiochemotherapy with temozolomide and 60 Gy
- •Patients before radiochemotherapy phase or within the first 2 weeks
- •Prescription of TTFields according clinical routine (including but not exclusive to)
- •Access to a computer and internet
- •Absence of medical reasons precluding participation in a supportive intervention
排除标准
- •Ability to understand and give an informed consent, capacity to consent
- •Given informed consent
- •≥ 18 years of age
- •Being a family caregiver of a patient with newly diagnosed glioblastoma
- •Access to a computer and internet
- •Absence of medical reasons precluding participation in a supportive intervention
结局指标
主要结局
EFFICACY of intervention
时间窗: 9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days)
Compliance to TTFields compared in intervention and control group.Compliance will be measured by the duration of the TTFields application in each patient
次要结局
- Safety of TTFields(9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days))
- Incidence of burdened caregivers(9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days))
- TOLERABILITY of psychooncological intervention(9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days))