Clinical trial NCT04969146: A Sleep Intervention for Cancer Patients and Their Caregivers
Official title: A Sleep Intervention for Cancer Patients and Their Caregivers
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Intervention
Control
Keywords: Sleep Quality
Depression
Quality of Life
Dyadic Function
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups receiving different interventions in parallel for the duration of the study
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria:

Patient

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Change from baseline in insomnia reduction at 6 months
measure: Insomnia Severity Index
timeFrame: Change from baseline in insomnia reduction at 12 months
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline in improved sleep latency at 6 months.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline in improved sleep latency at 12 months
measure: Patient-reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: Change from baseline in improved quality of life at 6 months
measure: Patient-reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: Change from baseline in improved quality of life at 12 months
Other outcomes:
measure: Patient-reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: Change from baseline in depressive symptoms at 6 months
measure: Patient-reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: Change from baseline in depressive symptoms at 12 months
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Montefiore Liver Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jennifer L Steel, PhD
role: PRINCIPAL_INVESTIGATOR
References: