Dyadic Sleep Study

NCT ID: NCT06569693

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-22
• Study Completion Date: 2026-12-01

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.

Conditions

Gastrointestinal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

MSOS Intervention Group

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.

Group Type: EXPERIMENTAL

My Sleep Our Sleep (MSOS) Program

Intervention Type: BEHAVIORAL

MSOS is a sleep intervention developed by the investigator aimed at improving sleep health for patient-sleep-partner caregiver dyads using behavioral education in sleep behaviors, sleep cognition and sleep in relationship.

MSOS will be delivered over four weeks, in weekly one-hour sessions, one session per week.

BBTI Intervention Group

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.

Group Type: EXPERIMENTAL

Brief Behavioral Treatment for Insomnia (BBTI)

Intervention Type: BEHAVIORAL

BBTI is brief patient-focused intervention for patient-sleep-partner caregiver dyads, aimed at altering participants' sleep behaviors to improve sleep. BBTI utilizes behavioral education in sleep restriction and stimulus control. For sleep restriction, participants will be instructed to limit the time they spend in bed, which serves to increase sleep efficiency. For stimulus control, participants will be instructed to go to bed only when feeling sleepy and reserve the bed for sleep and intimacy.

BBTI will be delivered over four weeks, in weekly one-hour sessions, one session per week.

Interventions

My Sleep Our Sleep (MSOS) Program

MSOS is a sleep intervention developed by the investigator aimed at improving sleep health for patient-sleep-partner caregiver dyads using behavioral education in sleep behaviors, sleep cognition and sleep in relationship.

MSOS will be delivered over four weeks, in weekly one-hour sessions, one session per week.

Intervention Type: BEHAVIORAL

Brief Behavioral Treatment for Insomnia (BBTI)

BBTI is brief patient-focused intervention for patient-sleep-partner caregiver dyads, aimed at altering participants' sleep behaviors to improve sleep. BBTI utilizes behavioral education in sleep restriction and stimulus control. For sleep restriction, participants will be instructed to limit the time they spend in bed, which serves to increase sleep efficiency. For stimulus control, participants will be instructed to go to bed only when feeling sleepy and reserve the bed for sleep and intimacy.

BBTI will be delivered over four weeks, in weekly one-hour sessions, one session per week.

Intervention Type: BEHAVIORAL

Other Intervention Names

MSOS; BBTI

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Youngmee Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Youngmee Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Coral Gables, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Youngmee Kim, PhD

Role: CONTACT

ykim@miami.edu

305-284-5439

Facility Contacts

Youngmee Kim, PhD

Role: primary

ykim@miami.edu

305-284-5439

References

Kim Y, Tsai TC, Steel JL, Ramos AR, Laurenceau JP, Troxel WM. Protocol of testing the feasibility and acceptability of two brief dyadic sleep interventions for adults with cancer and their bedpartner caregivers. Pilot Feasibility Stud. 2025 Jun 14;11(1):82. doi: 10.1186/s40814-025-01671-z.

Reference Type: DERIVED

PMID: 40514758 (View on PubMed)

Other Identifiers

R21NR021083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20240214

Identifier Type: -

Identifier Source: org_study_id