Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program

University of Miami1 个研究点分布在 1 个国家目标入组 26 人2021年3月14日

适应症Insomnia

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Insomnia
发起方: University of Miami
入组人数: 26
试验地点: 1
主要终点: Feasibility of the intervention
状态: 已完成
最后更新: 4年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

The purpose of this study is to test feasibility and acceptability of a psycho-behavioral intervention on sleep in cancer patients and their partners.

注册库

clinicaltrials.gov

开始日期

2021年3月14日

结束日期

2022年1月25日

最后更新

4年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

University of Miami

责任方

Principal Investigator

主要研究者

Youngmee Kim

Professor

University of Miami

入排标准

入选标准

•newly diagnosed with a gastrointestinal cancer (stage I to IV) 12 months or less prior to participating
•18 years or older
•able to speak/read English at the 5th grade level
•having a consistent partner who is involved in daily activities including sleep
•having 5 or greater score on the Pittsburgh Sleep Quality Index.
•Sleep partners:
•18 years or older
•able to speak/read English at the 5th grade level
•a partner of the patient who is involved in the patient's daily activities including sleep
•having similar circadian rhythm/sleep patterns with the patient

排除标准

•Patients and their sleep partners:
•having had a diagnosis of dementia, psychotic disorder, major depressive disorder, bipolar disorder, which currently has not been treated
•having active suicidality in the past year
•currently having an untreated diagnosed sleep disorder (narcolepsy, restless leg syndrome)
•currently having have a poor physical functioning status as measured by an Eastern Cooperative Oncology Group (ECOG) score of 3 or higher and Karnofsky grade of 50 or lower
•having poor cognitive function status as measured by the Mini Mental State Examination score of 24 or less
•unable to see or hear
•at the end of life (life expectancy of less than a month)
•unwilling to change their current sleep-related habits in near future.

结局指标

主要结局

Feasibility of the intervention

时间窗: 4 weeks

Feasibility of the intervention will be reported as the percentage of participants who enroll and complete all the sessions of the study.

Acceptability of the intervention

时间窗: 4 weeks

Acceptability of the intervention will be reported as the percentage of participants who evaluated the intervention and the interventionist as "satisfactory" or better.