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征服恐惧 SUPPORT 干预支持 III-IV 期肺癌或妇科癌症患者

2026年7月14日 更新者：City of Hope Medical Center

战胜恐惧 支持：晚期癌症患者的社会心理干预

该试验将在患有 III-IV 期肺癌或妇科癌症且害怕癌症进展的患者中试行一种称为征服恐惧支持 (CFS) 的社会心理干预措施。 该干预措施改编自澳大利亚研究人员开发的名为“征服恐惧”的新项目。 CFS 可能有助于减少晚期肺癌或妇科癌症患者的忧虑、恐惧和不确定性。

研究概览

地位

完全的

条件

干预/治疗

详细说明

主要目标：

I. 评估 CFS 干预对晚期肺癌和妇科 (GYN) 癌症（III 期或 IV 期）患者的可行性和可接受性，这些患者具有临床上显着水平的癌症进展恐惧症 (FOP) 或癌症相关的痛苦。

次要目标：

I. 评估干预对 FOP、癌症特异性痛苦、焦虑、抑郁、整体症状痛苦、元认知和正念的初步影响。

大纲：

患者参加 CFS 社会心理干预，包括 7 次由护士主持的会议（第 1 次面对面会议和第 2-7 次视频会议），每次超过 45 分钟，持续 8 周。 患者还完成了家庭练习作业，包括每次课程后的注意力训练技巧和正念练习课程。

研究干预完成后，患者在第 12 周接受随访。

研究类型

介入性

注册 (实际的)

39

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Duarte、California、美国、91010
        • City of Hope Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  • 将招募妇科 (GYN) 和肺癌患者
  • III 期或 IV 期疾病
  • 从初步诊断起至少 3 个月
  • 接受针对疾病的治疗或主动监测模式
  • 进展恐惧问卷 - 简表 (SF) 得分≥ 34 或事件量表影响 - 修订版得分≥ 24
  • 所有受试者必须具有理解能力并愿意签署书面知情同意书

排除标准：

  • 当前严重抑郁或精神病；显着的认知障碍
  • 参加临终关怀或选择不接受进一步以疾病为中心的治疗的患者
  • 目前正在接受精神科治疗的患者
  • 不会说英语

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：支持治疗 (CFS)

患者参加 CFS 社会心理干预，包括 7 次由护士主持的会议（第 1 次面对面会议和第 2-7 次视频会议），每次超过 45 分钟，持续 8 周。 每次疗程结束后，患者还需要完成包括注意力训练技巧和正念练习在内的家庭练习作业。

患者在基线 (T1)、8 周 (T2) 和 12 周 (T3) 时完成自我报告问卷。
其他：问卷管理
辅助研究
行为的：社会心理护理克服恐惧支持干预（心理教育、注意力训练、忧虑管理和超然正念成分）
出席粮安委
其他名称：
  • 克服恐惧支持

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Eligible Participants
大体时间：Up to 9 months
Enrollment rate will be deemed sufficient if at least 33 eligible patients are accrued within 9 months.
Up to 9 months
Attrition
大体时间：Up to Week 12
Feasibility of the Conquer Fear SUPPORT (CFS) intervention will be assessed by tracking attrition. Attrition is defined as the percentage of participants who withdraw from the study among enrolled participants who completed the baseline questionnaire (i.e., evaluable participants). Feasibility will be evaluated based on whether attrition remains within the prespecified study thresholds at Week 8 (T2) and Week 12 (T3).
Up to Week 12
Number of Sessions Attended
大体时间：Up to 12 weeks
Attendance was assessed as the number of intervention sessions attended by each participant. Seven intervention sessions were offered during the study period.
Up to 12 weeks
Percentage of Participants Who Reported Home Practice
大体时间：Up to 12 weeks
Home practice was assessed by participant self-report during the intervention period. The outcome reflects the percentage of participants who reported engaging in assigned home practice activities.
Up to 12 weeks
Percentage of Participants Who Completed All Assigned Home Practice
大体时间：Up to 12 weeks
Completion of assigned home practice was assessed by participant self-report during the intervention period. The outcome reflects the percentage of participants who reported completing all assigned home practice activities.
Up to 12 weeks
Percentage of Participants Who Reported Attention Training Practice for at Least One Week
大体时间：Up to 12 weeks
Attention training practice was assessed by participant self-report during the intervention period. The outcome reflects the percentage of participants who reported engaging in attention training practice for at least one week.
Up to 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Fear of Progression
大体时间：T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Fear of progression was assessed using the Fear of Progression Questionnaire-Short Form (FOP-Q-SF). The total score ranges from 12 (minimum) to 60 (maximum), with higher scores indicating worse outcomes (i.e., greater fear of progression). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).
T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Cancer-specific Distress
大体时间：T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Cancer-specific distress was assessed using the Impact of Event Scale-Revised (IES-R). The total score ranges from 0 (minimum) to 88 (maximum), with higher scores indicating worse outcomes (i.e., greater cancer-specific distress). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).
T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Anxiety
大体时间：T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Anxiety was assessed using the Patient-Reported Outcomes Measurement Information System Anxiety Short Form 8a (PROMIS-Anxiety 8a). Raw scores range from 8 (minimum) to 40 (maximum) and were converted to standardized T-scores (mean = 50, standard deviation = 10). In both scoring metrics, higher scores indicate worse outcomes (i.e., greater anxiety). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).
T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Depression
大体时间：T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Depression was assessed using the Patient Health Questionnaire-9 (PHQ-9). The total score ranges from 0 (minimum) to 27 (maximum), with higher scores indicating worse outcomes (i.e., more severe depressive symptoms). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).
T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Overall Symptom Distress
大体时间：T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Overall symptom distress was assessed using the Memorial Symptom Assessment Scale (MSAS). The total MSAS score (TMSAS) ranges from 0 (minimum) to 4 (maximum), with higher scores indicating worse outcomes (i.e., greater symptom severity and distress). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).
T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Metacognitions
大体时间：T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Metacognitions were assessed using the Metacognitions Questionnaire-30 (MCQ-30). The total score ranges from 30 (minimum) to 120 (maximum), with higher scores indicating worse outcomes (i.e., more dysfunctional metacognitions). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).
T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Mindfulness
大体时间：T1 (Baseline), T2 (Week 8), and T3 (Week 12)
Mindfulness was assessed using the Five Facet Mindfulness Questionnaire-15 (FFMQ-15), excluding the Observing subscale per scoring instructions. The total score ranges from 12 (minimum) to 60 (maximum), with higher scores indicating better outcomes (i.e., greater mindfulness). Assessments were conducted at three time points: T1 (Baseline), T2 (Week 8), and T3 (Week 12).
T1 (Baseline), T2 (Week 8), and T3 (Week 12)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

City of Hope Medical Center

合作者

National Cancer Institute (NCI)

调查人员

  • 首席研究员：Anne Reb, NP, PhD、City of Hope Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年11月15日

初级完成 (实际的)

2024年7月26日

研究完成 (实际的)

2024年8月26日

研究注册日期

首次提交

2018年10月31日

首先提交符合 QC 标准的

2018年12月12日

首次发布 (实际的)

2018年12月14日

研究记录更新

最后更新发布 (实际的)

2026年8月6日

上次提交的符合 QC 标准的更新

2026年7月14日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 18305 (其他标识符：City of Hope Medical Center)
  • NCI-2018-02405 (注册表标识符：CTRP (Clinical Trial Reporting Program))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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