A Sleep Intervention for Cancer Patients and Their Caregivers

Intervention Clinical Trial

Official title:

A Sleep Intervention for Cancer Patients and Their Caregivers

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04969146
• Other study ID #: STUDY19090202
• Status: Suspended
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: January 1, 2025
• Est. primary completion date: December 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Control
• Intervention

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center Montefiore Liver Cancer Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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