A Sleep Intervention for Cancer Patients and Their Caregivers

NCT04969146 | Completed DMC

• 1 other identifier: STUDY19090202
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Control; Intervention

Keywords

Sleep Quality; Depression; Quality of Life; Dyadic Function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline in improved sleep latency at 6 months.

• Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline in improved sleep latency at 12 months

• Patient-reported Outcomes Measurement Information System (PROMIS-29)

  Change from baseline in improved quality of life at 6 months

• Patient-reported Outcomes Measurement Information System (PROMIS-29)

  Change from baseline in improved quality of life at 12 months

Other Outcomes (2)

• Patient-reported Outcomes Measurement Information System (PROMIS-29)

  Change from baseline in depressive symptoms at 6 months

• Patient-reported Outcomes Measurement Information System (PROMIS-29)

  Change from baseline in depressive symptoms at 12 months

Study Arms (2)

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.

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

Behavioral: Patient Only Intervention

Interventions

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.

Modified Cognitive Behavioral Therapy Intervention Dyadic

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.

Modified Cognitive Behavioral Therapy Intervention Patient Only

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center Montefiore Liver Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jennifer L Steel, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Research Coordinators will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are assigned to one of two groups receiving different interventions in parallel for the duration of the study

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 20, 2021
• Study Start: December 5, 2016
• Primary Completion: April 4, 2026
• Study Completion: April 4, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available at the end of the study for up to one year.
• Access Criteria: Appropriate investigator credentials (MD, PhD) and request, and for up to one year after study completion

Locations

US (1)