FearLess in Neuro-Oncology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Feasibility - Study Retention at 24 Weeks
研究概览
简要总结
The overarching goal of this project is to assess the feasibility, acceptability, and appropriateness of recruitment methods, target population, and a waitlist design to finalize the protocol of FearLess in primary malignant brain tumor patients and caregivers
详细描述
The purpose of this study is to assess the feasibility, acceptability, appropriateness (FAA) of recruitment methods, study population, and waitlist design to finalize the protocol of FearLess, a psychological intervention targeting fear of cancer recurrence in primary malignant brain tumor patients and caregivers. Eligible participants (N=112) will be randomized to either: 1) immediate intervention or 2) delayed treatment control. Assessments will take place at baseline, Week 12, and Week 26.
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
- •Self-report a diagnosis of a primary malignant brain tumor (grade II-IV)
- •>2 weeks post-cranial resection or biopsy
- •Elevated Fear of Recurrence Distress Rating
- •Primarily English speaking
- •>/= 18 years of age at the time of enrollment
- •Caregivers:
- •nonprofessional caregiver to a patient with a primary malignant brain tumor (grade II-IV)
- •Elevated Fear of Recurrence Distress Rating
- •Primarily English speaking
- •>/= 18 years of age at the time of enrollment
排除标准
- •Patient / Caregiver Exclusion:
- •Cognitive impairment that might prohibit active intervention engagement
- •Inability to understand and provide informed consent
- •Inability to attend virtual sessions due to unstable or no internet connection
研究组 & 干预措施
FearLess Delayed Control Arm
FearLess is a newly developed, empirically-rooted, manualized psychological intervention consisting of an intake + 8 sessions delivered over a 12-week time period. It consists of weekly individual 60- to 90-minute virtual therapy sessions. In this arm, the FearLess intervention will begin following a 12-week no-treatment period.
干预措施: Fearless in Neuro-Oncology (Behavioral)
Fearless Immediate Treatment Arm
FearLess is a newly developed, empirically-rooted, manualized psychological intervention consisting of an intake + 8 sessions delivered over a 12-week time period. It consists of weekly individual 60- to 90-minute virtual therapy sessions. FearLess will be delivered immediately following enrollment in this arm.
干预措施: Fearless in Neuro-Oncology (Behavioral)
结局指标
主要结局
Feasibility - Study Retention at 24 Weeks
时间窗: From baseline assessment to 24 weeks
Study retention will be measured by comparing observed rates of 24-week assessment completion to pre-specified benchmarks.
Feasibility - Sustained Eligibility (Delayed Treatment Control Arm Only)
时间窗: From baseline to 12-week assessment
Feasibility of sustained trial eligibility will be assessed in the delayed treatment control arm only by comparing the proportion of participants who remain eligible at 12 weeks to a pre-determined threshold.
Acceptability - Intervention
时间窗: From baseline to 12-week assessment in the Immediate Intervention arm; from 12-week assessment to 24-week assessment in the Delayed Treatment Control arm
The acceptability of the intervention will be measured by comparing rates of intervention completion to pre-determined thresholds.
Feasibility - Study Enrollment
时间窗: From screening to randomization allocation
Feasibility of study enrollment using a multimodal recruitment approach will be assessed by comparing observed rates of screening completion, trial eligibility, trial enrollment (i.e., informed consent), and randomization allocation to pre-specified benchmarks.
Feasibility - Study Retention at 12 Weeks
时间窗: From baseline assessment to 12 weeks
Study retention will be measured by comparing observed rates of 12-week assessment completion to pre-specified benchmarks.
Acceptability - Trial Procedures
时间窗: Week 24
The acceptability of the trial procedures will be measured by comparing rates of participant satisfaction with randomization methodology and assessment procedures to pre-determined thresholds. The satisfaction measure consists of 4 Likert-scale items and 2 Yes/No items encompassing perceptions of satisfaction regarding randomization, intervention schedule, questionnaire burden, and honorarium.
Appropriateness - Interventionist Report
时间窗: At 12-week assessment in the Immediate Intervention arm; at 24-week assessment in the Delayed Treatment Control arm
Intervention appropriateness will be assessed by the study interventionists for each participant using the Intervention Appropriateness Measure (IAM). The IAM will be completed following each session; average score will be used for outcome analyses. The IAM is a 4-item standardized scale that measures the perceived fit, relevance, or compatibility of the intervention for a given practice setting, provider, or consumer, and/or perceived fit of the intervention to address a particular issue or problem. Items are rated on a Likert scale from 1=Completely Agree to 5=Completely Disagree.
次要结局
未报告次要终点