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临床试验/NCT04969146
NCT04969146暂停不适用

A Sleep Intervention for Cancer Patients and Their Caregivers

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2027年8月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
50
试验地点
1
主要终点
Insomnia Severity Index

研究概览

简要总结

The purpose of the study is to design and test a dyadic sleep intervention for patients diagnosed with cancer and their intimate partner.

详细描述

Sleep problems remain underdiagnosed and undertreated among cancer patients despite their high prevalence and consequences to quality of life and health. Hepatobiliary cancer patients have one of the highest rates of sleep problems with 59% reporting poor sleep quality and 43% reporting sleeping less than 6 hours per night. Sleep problems were found to be associated with clinical levels of depressive symptoms, elevations in pain and fatigue. Investigators have observed that short sleep duration was associated with increased risk of mortality in patients with hepatobiliary cancers. Inflammation has been hypothesized to mediate the link between sleep and mortality. In hepatobiliary cancer, short sleep duration was associated with elevations in Interleukin (IL)-6, IL-1, IL-1 and IL-2 and poor sleep quality with elevations in Interferon (IFN) Interleukin-2, after adjusting for tumor associated inflammation, mediated the link between sleep duration and survival. These pro-inflammatory cytokines are also related to tumor growth and development of metastases. Sleep problems of spouses or intimate partners of hepatobiliary cancer patients were also prevalent with 62% reporting poor sleep quality and 33% reporting sleep less than 6 hours per night. Caregiving for an intimate partner with cancer has been linked to increased mortality and sleep has been proposed as a possible mediator of this link. Face to face cognitive behavioral therapy (CBT) has been shown to be effective in cancer patients and cancer caregivers. However, due to the distance patients travel to our medical center (58% >1 hour), infrequency of visits (e.g., approximately every two months), limited resources (48% of patients <$20,000 annual income), and the unpredictability of cancer-related symptoms; weekly face-to- face CBT to treat sleep problems is not feasible. Therefore, investigators will test a dyadic Modified Cognitive Behavioral Therapy for Insomnia (CBTi) intervention to reduce insomnia in patients and possibly caregivers and expect the findings of this study to have a significant public health impact for the over 12 million cancer patients and spousal/partner caregivers in which nearly half are estimated to suffer from sleep problems.

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
Single (Investigator)

盲法说明

Research Coordinators will be masked

入排标准

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

入选标准

  • Diagnosed with cancer
  • Screens positive for sleep problems (5 or greater score on the PSQI)
  • Shares a bed with the caregiver/intimate partner
  • Patient's caregiver/intimate partner also screens positive for sleep problems (5 or greater score on the PSQI)

排除标准

  • Patient or Caregiver
  • does not screen positive for sleep problems
  • has been diagnosed with sleep apnea or use a continuous positive airway pressure (CPAP) machine
  • has been diagnosed with narcolepsy or restless legs
  • works in a job that requires shift changes
  • does not speak/read English
  • does not share a bed with intimate partner

研究组 & 干预措施

Modified Cognitive Behavioral Therapy Intervention Dyadic

Experimental

The patient and caregiver in the dyadic intervention will have 5 sessions of Modified CBTi. The patient and caregiver will complete the assessment at 3- and 6 months follow up.

干预措施: Dyadic Intervention (Behavioral)

Modified Cognitive Behavioral Therapy Intervention Patient Only

Experimental

The patient in the patient only intervention arm will receive 5 sessions of Modified CBTi. The patient and caregiver will complete the assessment at 3- and 6 months follow up

干预措施: Patient Only Intervention (Behavioral)

结局指标

主要结局

Insomnia Severity Index

时间窗: Change from baseline in insomnia reduction at 12 months

Insomnia Reduction by 50% -Total Score (0-28, where 28 is most severe)

Insomnia Severity Index

时间窗: Change from baseline in insomnia reduction at 6 months

Insomnia Reduction by 50% -Total Score (0-28, where 28 is most severe)

次要结局

  • Pittsburgh Sleep Quality Index (PSQI)(Change from baseline in improved sleep latency at 12 months)
  • Patient-reported Outcomes Measurement Information System (PROMIS-29)(Change from baseline in improved quality of life at 12 months)
  • Pittsburgh Sleep Quality Index (PSQI)(Change from baseline in improved sleep latency at 6 months.)
  • Patient-reported Outcomes Measurement Information System (PROMIS-29)(Change from baseline in improved quality of life at 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Steel

Professor

University of Pittsburgh

研究点 (1)

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