An ACT-Based Supportive Intervention for Patients With Central Nervous System Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention
研究概览
简要总结
The goal of this study is to refine and test a psychosocial intervention called ASCENT (ACT-based Supportive intervention for patients with CENTral nervous system tumors). This intervention was developed to help patients after being diagnosed with a brain tumor. The main question this study aims to answer is whether this intervention is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to patients. Participants will be asked to take part in 6 coaching sessions and complete short surveys at four different time points. Some participants will be asked to share feedback via interviews.
详细描述
This study will examine the feasibility and acceptability of a novel, population-specific intervention designed to help patients with newly diagnosed malignant brain tumors cope with their illness.
This project is currently recruiting participants for intervention refinement activities in preparation for the pilot RCT. For intervention refinement, we are enrolling 15 stakeholders and 10 open pilot participants to gather feedback about the intervention to improve it prior to commencing the randomized controlled trial. The stakeholder feedback and open pilot refinement phase of the study is critical for intervention refinement for the RCT. The investigators will then evaluate the feasibility and acceptability of the refined ASCENT intervention versus usual care in this pilot randomized controlled trial (n=100). The investigators will also estimate preliminary effects of ASCENT on psychological and behavioral outcomes.
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
- •Massachusetts General Hospital Cancer Center Patient
- •Within 6 months of diagnosis of malignant primary Central Nervous System (CNS) tumor
- •English speaking
排除标准
- •Inability to provide informed consent as assessed by the study team (e.g., due to severe cognitive impairment/dementia)
- •Moderate to severe receptive aphasia (Quick Aphasia Battery sentence comprehension subscale < 8)
- •Current or imminent hospice enrollment
结局指标
主要结局
Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention
时间窗: 12 weeks
The investigators will assess acceptability via examining the distribution of patient scores for the 8-item Client Satisfaction Questionnaire (CSQ-8). CSQ-8 scores range from 8 to 32, with higher scores indicating higher satisfaction. The intervention will be deemed acceptable if at least 70% of patients score at least 24 points on the CSQ-8.
Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention
时间窗: Up to 12 weeks
The investigators will assess feasibility by examining the percentage of eligible patients who agree to enroll in the study and the percentage of enrolled patients who participate in all six intervention sessions. The intervention will be deemed feasible if at least 60% of eligible patients enroll in the study and if at least 70% of enrolled patients complete at least half of the sessions.
次要结局
- Exploratory: Anxiety symptoms(Up to 16 weeks)
- Exploratory: Prognostic distress(Up to 16 weeks)
- Exploratory: Quality of Life(Up to 16 weeks)
- Exploratory: Depression symptoms(Up to 16 weeks)
- Exploratory: Coping Skills(Up to 16 weeks)
- Exploratory: Values-driven behavior(Up to 16 weeks)
- Exploratory: Loneliness(Up to 16 weeks)
研究者
Deborah A Forst
Principal Investigator
Massachusetts General Hospital