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Completed

NCT Number: NCT04969146

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center Montefiore Liver Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dyadic intervention

Behavioral

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.

Patient Only Intervention

Behavioral

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.

Primary outcomes

  1. Insomnia Severity Index

    Time frame: Change from baseline in insomnia reduction at 6 months

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

  2. Insomnia Severity Index

    Time frame: Change from baseline in insomnia reduction at 12 months

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

Secondary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from baseline in improved sleep latency at 6 months.

    Improved Sleep Latency by 25% - Global Score ranging from 0 to 21, where lower score indicates better quality of sleep

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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

  3. Patient-reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: Change from baseline in improved quality of life at 6 months

    Increase in Quality of Life by 25% - total score ranging from 20-80, where lower scores indicate better quality of life

  4. Patient-reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: 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

Other outcomes

  1. Patient-reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: Change from baseline in depressive symptoms at 6 months

    Reduction of Depressive Symptoms by 25%- total score ranging from 20-80, where lower scores indicate better quality of life

  2. Patient-reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: Change from baseline in depressive symptoms at 12 months

    Reduction of Depressive Symptoms by 25%- total score ranging from 20-80, where lower scores indicate better quality of life

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2021
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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