Dyadic Sleep Study

Not Applicable

Recruiting

• Conditions: Gastrointestinal Cancer
• Interventions: Behavioral: My Sleep Our Sleep (MSOS) Program; Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)

• Registration Number: NCT06569693
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Study Start: 2024-10-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• The eligibility criteria for patients are:

  • newly diagnosed with stage I to IV of a GI cancer (anus, colon, esophagus, gallbladder, large and small intestine, liver, pancreas, rectum, stomach, other biliary or digestive organs)
  • diagnosis in the past 12 months at the time of enrollment
  • having a consistent sleep partner.

• The eligibility criterion for caregivers is:

  • a sleep partner of the patient.

• Additional eligibility criteria for both patients and caregivers are:

  • Pittsburgh Sleep Quality Index (PSQI) ≥ 5,
  • willing to change sub-optimal sleep habits,
  • 18 years or older,
  • able to speak/listen English at the 8th grade level for intervention sessions,
  • able to read English or Spanish at the 8th grade for self-reported questionnaires,
  • > 4 weeks after surgery, if any, prior to enrollment, and no surgery planned in the next 5 weeks during the study period because surgery affects sleep.

Exclusion Criteria

• Exclusion criteria for both patients and caregivers are having had a diagnosis of major depressive disorder, psychosis, or bipolar disorder that is not currently treated;
• Active suicidality, or substance or alcohol dependency in the past year;
• Currently have narcolepsy, restless leg syndrome, or untreated sleep apnea that is screened using the Sleep Health Screen;
• Both patients and caregivers have an extreme chronotype, or do shift work to have no overlap in sleep schedule between them; and plan trans-meridian travel during the period of data collection blocks; and having hearing or visual impairment, dementia, or cognitive dysfunction.
• Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MSOS Intervention Group	My Sleep Our Sleep (MSOS) Program	Participants (patient-sleep-partner caregiver dyads) in this group will receive the My Sleep Our Sleep (MSOS) intervention. Total participation is up to 13 weeks.
BBTI Intervention Group	Brief Behavioral Treatment for Insomnia (BBTI)	Participants (patient-sleep-partner caregiver dyads) in this group will receive the Brief Behavioral Treatment for Insomnia (BBTI). Total participation is up to 13 weeks.

Primary Outcome Measures

Name	Time	Method
Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI)	Baseline, Up to 13 weeks	Change in sleep disturbance symptoms (patient-sleep-partner caregiver dyads) among participants will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-reported, 19-item questionnaire health-related quality of life (HRQOL) questionnaire which assesses sleep quality and disturbances at baseline, week 5 and week 13. Questions generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. A decrease of ≥ 5 points on the PSQI) will be considered as clinical improvement of symptoms.

Secondary Outcome Measures

Name	Time	Method
Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI)	Baseline, Up to 13 weeks	Change in insomnia symptoms among participants (patient-sleep-partner caregiver dyads) will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the 7-item Insomnia Severity Index (ISI). The ISI is a self-reported, health-related quality of life (HRQOL) questionnaire used to assess insomnia symptoms at baseline, week 5 and week 13. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, notice ability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item, ranging from 0 to 4 (e.g., 0 = no problem; 4 = very severe problem). The total score ranges from 0 to 28, the lower total score indicates a lower level of insomnia. Greater than a 6-point decrease on the ISI is considered substantial reduction in insomnia symptoms.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Coral Gables, Florida, United States