NeuroCARE: Psychological Intervention for Caregivers of Patients With Malignant Gliomas (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Anxiety symptoms
研究概览
简要总结
This study is testing a supportive psychosocial intervention for caregivers of people who have malignant brain tumors such as gliomas or other high-grade primary brain tumors. This study was designed because caregivers of patients with malignant brain tumors often experience physical and psychological burdens caring for their loved ones.
The purpose of this study is to find out whether a program offering psychological support can help caregivers learn effective coping methods during their loved one's treatment and make the experience of being a caregiver more manageable.
详细描述
This study will be a prospective, randomized controlled trial to assess the efficacy of a caregiver-directed intervention designed to improve anxiety in caregivers of patients with malignant brain tumors, in comparison with caregivers who receive usual care.
The aim of this study is to test the efficacy of this intervention in reducing distress in caregivers of patients with malignant brain tumors, in comparison with usual care. The study will be conducted in 120 caregivers.
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
- 是
入选标准
- •Identified by study staff, a clinician, self, or a patient with a malignant brain tumor as the patient's primary caregiver
- •The patient is receiving care at the MGH Cancer Center
- •The patient was diagnosed with a malignant brain tumor within the past 6 months
- •Able to speak and read in English
- •Generalized Anxiety Disorder 7-item (GAD-7) score ≥5
- •Participants may or may not be pregnant.
排除标准
- •Deemed inappropriate for the study by the patient's clinician or the study PI
- •Participated in the pilot study of this caregiver intervention (DF/HCC 18-426)
结局指标
主要结局
Anxiety symptoms
时间窗: 11 weeks
We will compare anxiety symptoms using the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS-A) between the intervention and usual care group. The HADS-A is a 7-item subscale with scores ranging from 0 to 21, with higher scores indicating higher levels of anxiety.
次要结局
- Self-Efficacy(Up to 16 weeks)
- Anxiety symptoms longitudinally(Up to 16 weeks)
- Quality of life using the Caregiver quality of life oncology questionnaire(Up to 16 weeks)
- Caregiver burden(Up to 16 weeks)
- Coping skills(Up to 16 weeks)
- Depression symptoms(Up to 16 weeks)
- PTSD symptoms(Up to 16 weeks)
研究者
Deborah A Forst
Principal Investigator
Massachusetts General Hospital