Coping With High Grade Glioma
Purpose and Objective:
To determine the feasibility and short- and long-term efficacy of an empirically-based CST intervention (Keefe et al.) with caregivers of patients with primary malignant brain cancer.
Study Activities and Population Group:
The target sample will be 20 caregiver-patient dyads. Using a randomized controlled, prospective design, potentially eligible participants will be identified at the time of initial consultation (see Figure 1). Outcomes will be assessed at baseline, post-intervention (3 months post-randomization), 6 months post-randomization, and every 4 months up to 2-years in the event that the patient dies.
- Data Analysis and Risk/Safety Issues:
With only 10 subjects per group we do not have statistical power for direct hypothesis testing. Nevertheless, p-values will be presented for some analyses (chi-square tests, t-tests, and Spearman correlations) simply to aid in interpretation of results. In no way will these p-values be used to declare statistical significance or non-significance of the test results. Accordingly, the primary focus will be the means, variances, and covariances of the study endpoints, as well as the change scores in these endpoints across the study intervention and their 95% confidence limits.
研究概览
详细说明
The purpose of this study is to determine the feasibility and short- and long-term efficacy of an empirically-based CST intervention (Keefe et al.) with caregivers of patients with primary malignant brain cancer. The target sample will be 20 caregiver-patient dyads. The caregiver may be a spouse/partner, family member or friend,. Additional inclusion criteria will include: (1) caregiver provides a weekly minimum of 4 hours of caregiving; (2) caregiver is 18 years or older; (3) caregiver reading level at or above 8th grade; (4) caregiver sufficiently fluent in English; (5) the patient shows evidence of problems in depression, fatigue, sleep disturbance, and/or cognitive impairment as per the treating neuro-oncologist; (6) the caregiver and patient are willing to be randomized to treatment or usual care condition; (7) patient is within 3 months of initial diagnosis; (8) patient has life expectancy of at least 6 months or more; (9) the caregiver is willing to participate in treatment sessions using a telephone. If a patient dies during the active 12-week study phase, then the caregiver will be transitioned to the follow-up phase or removed from the study and, if needed, be referred for appropriate psychiatric or psychological treatment.
Using a randomized controlled, prospective design, potentially eligible participants will be identified at the time of initial consultation. Outcomes will be assessed at baseline, post-intervention (3 months post-randomization), 6 months post-randomization, and every 4 months up to 2-years in the event that the patient dies. If the subject is assigned to the intervention, they will be asked to complete 12 weeks of a coping skills training intervention. The coping skills intervention will consist of six telephone conversations during which they will learn strategies to reduce stress. The strategies will include ways to improve problem solving, communication skills, and managing activities. The subject will also be asked to complete a packet of questionnaires which will take about 1 hour to do. The subject will be asked to complete the questionnaires multiple times during the study (before the coping skills intervention, during the week after the coping skills intervention, and 3 months after the coping skills intervention). If the subject is assigned to the usual care condition, they will be asked to complete assessments at the same time intervals as caregivers in the active coping skills intervention. In either condition, in the event that the patient dies, the caregiver will also be asked to complete assessments every four months for one year. Patients will be asked to participate in sessions and complete questionnaires as they are able to.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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North Carolina
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Durham、North Carolina、美国、27710
- The Preston Robert Tisch Brain Tumor Center at Duke
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
The caregiver may be a spouse/partner, family member or friend. Additional inclusion criteria will include:
- caregiver provides a weekly minimum of 4 hours of caregiving;
- caregiver is 18 years or older;
- caregiver reading level at or above 8th grade;
- caregiver sufficiently fluent in English;
- the patient shows evidence of problems in depression, fatigue, sleep disturbance, and/or cognitive impairment as per the treating neuro-oncologist;
- the caregiver and patient are willing to be randomized to treatment or usual care condition;
- patient is within 3 months of initial diagnosis;
- patient has life expectancy of at least 6 months or more;
- the caregiver is willing to participate in treatment sessions using a telephone. If a patient dies during the active 12-week study phase, then the caregiver will be transitioned to the follow-up phase or removed from the study and, if needed, be referred for appropriate psychiatric or psychological treatment.
Exclusion Criteria:
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学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:1
Twenty five caregivers will randomly be assigned to receive active coping skills training and 25 caregivers will randomly receive usual care at The Preston Robert Tisch Brain Tumor Center at Duke.
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The strategies will include ways to improve problem solving, communication skills, and managing activities.
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安慰剂比较:2
Caregivers that will receive ususal care.
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The ususal care at the Preston Robert Tisch Brain Tumor Center
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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To explore the effects of a coping skills training (CST) intervention on distress, self-efficacy and other related outcomes among caregivers of high grade glioma patients.
大体时间:2 years
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2 years
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合作者和调查者
调查人员
- 首席研究员:Bart Brigidi, PhD、Duke University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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