A Sleep Intervention for Cancer Patients and Their Caregivers

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

Study Overview

• Status: Completed
• Conditions: Intervention; Control
• Intervention / Treatment: Behavioral: Dyadic Intervention; Behavioral: Patient Only Intervention

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center Montefiore Liver Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Cognitive Behavioral Therapy Intervention Dyadic; 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.	Behavioral: Dyadic Intervention; The patient and caregiver dyads will complete and return baseline questionnaires and then be randomized to Modified CBTi Dyadic Intervention. The patient and caregiver in the dyadic intervention will have 5 sessions of Modified CBTi. Upon completion of the intervention, the patient and caregiver will complete the follow up assessments at approximately 3 months and 6 months after the baseline questionnaires.
Experimental: Modified Cognitive Behavioral Therapy Intervention Patient Only; 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	Behavioral: Patient Only Intervention; The patient and caregiver dyads will complete and return baseline questionnaires and then be randomized to Modified CBTi Patient Only Intervention. The patient in the Patient Only Intervention will have 5 sessions of Modified CBTi. Upon completion of the intervention, the patient and caregiver will complete the follow up assessments at approximately 3 months and 6 months after the baseline questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index	Insomnia Reduction by 50% -Total Score (0-28, where 28 is most severe)	Change from baseline in insomnia reduction at 6 months
Insomnia Severity Index	Insomnia Reduction by 50% -Total Score (0-28, where 28 is most severe)	Change from baseline in insomnia reduction at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index (PSQI)	Improved Sleep Latency by 25% - Global Score ranging from 0 to 21, where lower score indicates better quality of sleep	Change from baseline in improved sleep latency at 6 months.
Pittsburgh Sleep Quality Index (PSQI)	Improved Sleep Latency by 25% - Global Score ranging from 0 to 21, where lower score indicates better quality of sleep	Change from baseline in improved sleep latency at 12 months
Patient-reported Outcomes Measurement Information System (PROMIS-29)	Increase in Quality of Life by 25% - total score ranging from 20-80, where lower scores indicate better quality of life	Change from baseline in improved quality of life at 6 months
Patient-reported Outcomes Measurement Information System (PROMIS-29)	Increase in Quality of Life by 25% - total score ranging from 20-80, where lower scores indicate better quality of life	Change from baseline in improved quality of life at 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported Outcomes Measurement Information System (PROMIS-29)	Reduction of Depressive Symptoms by 25%- total score ranging from 20-80, where lower scores indicate better quality of life	Change from baseline in depressive symptoms at 6 months
Patient-reported Outcomes Measurement Information System (PROMIS-29)	Reduction of Depressive Symptoms by 25%- total score ranging from 20-80, where lower scores indicate better quality of life	Change from baseline in depressive symptoms at 12 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Jennifer L Steel, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2016
• Primary Completion (Actual): April 4, 2026
• Study Completion (Actual): April 4, 2026

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Quality of Life; Sleep Quality; Dyadic Function
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Depression; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: STUDY19090202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-Identified Data may be shared with investigators who request data from the Primary Investigator
• IPD Sharing Time Frame: Data will be available at the end of the study for up to one year.
• IPD Sharing Access Criteria: Appropriate investigator credentials (MD, PhD) and request, and for up to one year after study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No