A Sleep Intervention for Cancer Patients and Their Caregivers

Not Applicable

Suspended

• Conditions: Intervention; Control
• Interventions: Behavioral: Patient Only Intervention; Behavioral: Dyadic Intervention

• Registration Number: NCT04969146
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-20
• Study Start: 2021-08-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-12-23
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Cognitive Behavioral Therapy Intervention Patient Only	Patient Only Intervention	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
Modified Cognitive Behavioral Therapy Intervention Dyadic	Dyadic Intervention	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.

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	Change from baseline in insomnia reduction at 12 months	Insomnia Reduction by 50% -Total Score (0-28, where 28 is most severe)

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	Change from baseline in improved sleep latency at 12 months	Improved Sleep Latency by 25% - Global Score ranging from 0 to 21, where lower score indicates better quality of sleep
Patient-reported Outcomes Measurement Information System (PROMIS-29)	Change from baseline in improved quality of life at 12 months	Increase in Quality of Life by 25% - total score ranging from 20-80, where lower scores indicate better quality of life

Trial Locations

Locations (1)

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