FearLess in Cognitively Intact Patients With Glioma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Determine the acceptability of FearLess intervention- Attendance
研究概览
简要总结
This study will assess the preliminary feasibility and acceptability of FearLess, a newly-developed psychological intervention for fear of cancer recurrence (FCR) among cognitively-intact patients with glioma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patient inclusion:
- •Confirmed glioma diagnosis (grade II-IV) via histopathology
- •Be a minimum of 2 weeks post surgical repair or biopsy (if applicable)
- •Elevated FCR [> 13 on Fear of Cancer Recurrence Inventory]
- •Primarily English speaking
- •Caregiver Inclusion:
- •Loved one, or non-paid care partner to a patient with a confirmed glioma diagnosis (grade II-IV) via histopathology
- •Elevated FCR [> 13 on Fear of Cancer Recurrence Inventory]
- •Primarily English speaking
排除标准
- •Cognitive impairment [< or equal to 31 on the Telephone Interview for Cognitive Status (TICS)]
- •Inability to attend virtual sessions (e.g. due to lack of stable internet connection, difficulty using technology)
- •Inability to understand and provide informed consent.
- •Inability to attend virtual sessions (e.g. due to lack of stable internet connection, difficulty using technology)
- •Inability to understand and provide informed consent.
结局指标
主要结局
Determine the acceptability of FearLess intervention- Attendance
时间窗: 12 Weeks
As evidenced by attendance rate at intervention sessions
Determine feasibility of FearLess recruitment
时间窗: 1 Day
As evidenced by the number of patients and caregivers that enroll in the trial
Determine the feasibility of FearLess intervention- Data collection procedures
时间窗: 12 Weeks
As evidenced by the number of participants that complete the baseline assessment, post-intervention assessment, and the exit interview
Determine the acceptability of FearLess intervention- Retention Rate
时间窗: 12 Weeks
As evidenced by the number of patients that complete follow-up measures
Determine the acceptability of FearLess intervention- Satisfaction
时间窗: 12 Weeks
As evidenced by the number of patients with a satisfaction rating greater than 7 on a 10 point scale
Determine the acceptability of FearLess intervention- Satisfaction- Recommendation
时间窗: 12 Weeks
As evidenced by the number of patients that recommend the intervention to others
次要结局
未报告次要终点