Dyadic Sleep Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: My Sleep Our Sleep (MSOS) Program (Behavioral)
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.
干预措施: Brief Behavioral Treatment for Insomnia (BBTI) (Behavioral)
结局指标
主要结局
Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI)
时间窗: 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.
次要结局
- Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI)(Baseline, Up to 13 weeks)
研究者
Youngmee Kim
Professor
University of Miami