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Spots Global Cancer Trial Database for A Sleep Intervention for Cancer Patients and Their Caregivers

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Trial Identification

Brief Title: A Sleep Intervention for Cancer Patients and Their Caregivers

Official Title: A Sleep Intervention for Cancer Patients and Their Caregivers

Study ID: NCT04969146

Study Description

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

Detailed Description: 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.

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

University of Pittsburgh Medical Center Montefiore Liver Cancer Center, Pittsburgh, Pennsylvania, United States

Contact Details

Name: Jennifer L Steel, PhD

Affiliation: University of Pittsburgh

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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