Dyadic Sleep Study

Обзор

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

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, Up to 13 weeks]

Вторичные конечные точки (1)

• Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI) [Срок оценки: Baseline, Up to 13 weeks]

Критерии участия

Критерии включения

• 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 72 months at the time of enrollment
• having a consistent sleep partner.
• The eligibility criterion for caregivers is:

• a sleep partner of the patient or partner who wish to resume sleeping together with 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• University of Miami — Coral Gables
• University of Pittsburgh — Pittsburgh

Публикации

• 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. PMID 40514758

Идентификаторы

NCT: NCT06569693 · 20240214 · R21NR021083

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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