A Sleep Intervention for Cancer Patients and Their Caregivers

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Sleep Intervention for Cancer Patients and Their Caregivers

Conditions
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Intervention, Control

Intervention / Treatment
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* Behavioral: Dyadic Intervention
* Behavioral: Patient Only Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of two groups receiving different interventions in parallel for the duration of the study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Cognitive Behavioral Therapy Intervention Dyadic<br>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<br>* 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.<br>|
| Experimental: Modified Cognitive Behavioral Therapy Intervention Patient Only<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Quality, Depression, Quality of Life, Dyadic Function