Project SUGRI - a Supportive Group Intervention for Caregivers to Patients Diagnosed With a Glioblastoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility parametres
研究概览
简要总结
Feasibility test and evaluation of a group intervention for caregivers to patients diagnosed with a glioblastoma.
详细描述
Methods and design:
The study is a three-phase sequential mixed-method feasibility study. The overall framework is guided by the British Medical Research Council framework for developing Complex Intervention. The study will apply Patient and Public Involvement (PPI) to design and develop the intervention. The study will test the feasibility of the newly designed group intervention.
Participants:
Family caregivers (≥18 years) to patients (≥18 years) diagnosed with a GBM grade IV or diffuse astrocytoma grade IV offered standard oncological treatment. Participants must be able to understand, read, and speak Danish.
Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Family caregivers (≥18 years) to patients (≥18 years) diagnosed with a GBM grade IV or diffuse astrocytoma grade IV offered Stupps treatment regime.
排除标准
- •Participants who do not understand, read, and speak Danish.
研究组 & 干预措施
A supportive group intervention
The intervention consists of following four elements:
- Weekly HCP facilitated online group meetings for caregivers (n=12) over three months
- Access to a webpage with informational videos of health care professionals and videos with other caregivers
- Offer a box of reflection cards and cards to provide caregivers with help
- Access to a closed online Facebook group
干预措施: Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastoma (Other)
结局指标
主要结局
Feasibility parametres
时间窗: The final evaluation of the feasibility of the intervention will be conducted after the completion of the intervention, which is scheduled to last 12 weeks.
The primary outcome is the feasibility of the intervention. Accurate feasibility parameters will be outlined when the intervention is fully designed. However, we will most likely access recruitment rate, adherence to the overall intervention, acceptability, and safety. We will establish the final percentages for feasibility within each parameter prior test of the intervention and use these to report the overall feasibility of the intervention. Final percentages will be guided by other feasibility studies within the neuro-oncology field.
次要结局
- Quantitative PRO data(Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).)
- Qualitative interview data(Post-intervention (Week 12))
- Quantitative PRO data(Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks)..)
研究者
Tiit Mathiesen
Tiit Mathiesen, Professor in Neurosurgery
Rigshospitalet, Denmark