InterventionNCT04969146
A Sleep Intervention for Cancer Patients and Their Caregivers
A study testing Dyadic Intervention and Patient Only Intervention in people with Intervention and Control, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intervention, Control
- What is being tested?
- Dyadic Intervention and Patient Only Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2016to 4 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center Montefiore Liver Cancer Center
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of the study is to design and test a dyadic sleep intervention for patients diagnosed with cancer and their intimate partner.
Read the 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.
- Conditions
- Intervention, Control
- Being tested
- Dyadic Intervention, Patient Only Intervention
- Keywords
- Sleep Quality, Depression, Quality of Life, Dyadic Function
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic InterventionBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Modified Cognitive Behavioral Therapy Intervention Dyadic | Experimental | 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. Receives: Behavioral: Dyadic Intervention |
| Modified Cognitive Behavioral Therapy Intervention Patient Only | Experimental | 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 Receives: Behavioral: Patient Only Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Insomnia Reduction by 50% -Total Score (0-28, where 28 is most severe)
Measured: 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)
Measured: Change from baseline in insomnia reduction at 12 months
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline in improved quality of life at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start5 Dec 2016
- Primary completion4 Apr 2026
- Study completion4 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterventionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups receiving different interventions in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Steel, University of Pittsburgh
- Investigators
- Jennifer L Steel, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969146
- Sponsor's protocol ID
- STUDY19090202
- Status last verified
- Apr 2026
- First submitted
- 16 Jul 2021
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-Identified Data may be shared with investigators who request data from the Primary Investigator
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sleep Intervention for Cancer Patients and Their Caregivers
- ClinicalTrials.gov ID
- NCT04969146
- Acronym / sponsor ID
- STUDY19090202
- Conditions
- Intervention, Control
- Keywords
- Sleep Quality, Depression, Quality of Life, Dyadic Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 4 Apr 2026 (actual)
- Study completion
- 4 Apr 2026 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups receiving different interventions in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Modified Cognitive Behavioral Therapy Intervention Dyadic | Experimental | Behavioral: Dyadic InterventionThe 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. |
| Modified Cognitive Behavioral Therapy Intervention Patient Only | Experimental | Behavioral: Patient Only InterventionThe 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic InterventionThe 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. | Behavioural | Modified Cognitive Behavioral Therapy Intervention Dyadic |
| Patient Only InterventionThe 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. | Behavioural | Modified Cognitive Behavioral Therapy Intervention Patient Only |
Primary outcome
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)
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)
4 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline in improved sleep latency at 6 months.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline in improved sleep latency at 12 months
Patient-reported Outcomes Measurement Information System (PROMIS-29)
Time frame: Change from baseline in improved quality of life at 6 months
Patient-reported Outcomes Measurement Information System (PROMIS-29)
Time frame: Change from baseline in improved quality of life at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. De-Identified Data may be shared with investigators who request data from the Primary Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Steel, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic Intervention and Patient Only Intervention in people with Intervention and Control, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: Change from baseline in insomnia reduction at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.