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临床试验/NCT02706301
NCT02706301已完成不适用

Pain Coping Skills Training for Colorectal Cancer Survivors With Pain and Distress

Duke University2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2016年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Change in Pain Severity assessed using the Brief Pain Inventory (BPI)

研究概览

简要总结

Colorectal cancer survivors experience long-term negative physical and psychosocial consequences of their disease. There is a critical need to develop novel behavioral interventions for improving colorectal cancer survivor outcomes. The investigators have developed a pain management intervention for colorectal cancer survivors that focuses on addressing both pain and psychological distress. Colorectal cancer survivors who endorse pain and comorbid psychological distress as a concern during a clinic-based survivorship care consult will be recruited. Participants will be randomized into either: Telephone-Based Coping Skills Training (CST) for pain and comorbid psychological distress or standard care. The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain and psychological distress. The standard care control condition will receive resources and referrals related to managing survivorship health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >21 years old
  • personal history of colorectal cancer
  • finished active cancer treatment within the past 12 months
  • reported pain as a concern as well as psychological distress on a National Comprehensive Cancer Network screener
  • able to speak and read English
  • able and willing to give informed consent

排除标准

  • currently undergoing active cancer treatment
  • have a major mental illness (e.g., schizophrenia)
  • have a mental illness that is not being treated/controlled (e.g., bipolar disorder)

研究组 & 干预措施

Telephone-Based Coping Skills Training (CST)

Experimental

The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain as well as psychological distress.

干预措施: Telephone-Based Coping Skills Training (CST) (Behavioral)

Standard care control

No Intervention

The standard care control condition will receive resources and referrals related to survivorship health. This information will be provided to the participant during their initial survivorship care consult.

结局指标

主要结局

Change in Pain Severity assessed using the Brief Pain Inventory (BPI)

时间窗: pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks)

Brief Pain Inventory (BPI)

次要结局

  • Change in Quality of Life assessed using the FACT-G, version 4.0(pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks))
  • Change in Psychological Distress assessed using the Brief Symptom Inventory (BSI)(pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks))
  • Change in Self-Efficacy for Pain Control assessed using the subscale of the Chronic Pain Self-Efficacy Scale(pre-treatment (baseline), post-treatment (approximately 8 weeks), 3-months post-treatment (approximately 20 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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