Sleep Treatment Education Program Together (STEP-Together): An Online Group Educational Intervention for Insomnia in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention
研究概览
简要总结
This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a synchronous group session by videoconference.
详细描述
This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a virtual group session.
The research study procedures including screening for eligibility and questionnaires.
Participation in this research study is expected to last about 16 weeks.
It is expected about 90 people will participate in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-89
- •History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 6 months prior
- •No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned.
- •Significant insomnia as evidenced by an Insomnia Severity Index score ≥ 8
- •Regular access to the internet
- •Able to read and write in English
排除标准
- •Usual bedtime does not fall between 5:00 pm and 5:00 am.
- •Employment in a position where falling asleep at work could impact public safety (such as air traffic-controller, operating heavy machinery).
- •Ever diagnosed with Bipolar Disorder or with Seizure Disorder, currently taking medications to prevent a seizure, or have experienced a seizure in the prior 12 months.
- •Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.
研究组 & 干预措施
STEP-Together Intervention
Enrolled participants will complete the educational intervention session (STEP-Together) delivered by an interventionist during an online group videoconference session.
-Up to 12 participants will also take part in a coaching session 1 week after the virtual intervention session.
干预措施: The Sleep Treatment Education Program Together (STEP-Together) (Behavioral)
STEP-Together Intervention
Enrolled participants will complete the educational intervention session (STEP-Together) delivered by an interventionist during an online group videoconference session.
-Up to 12 participants will also take part in a coaching session 1 week after the virtual intervention session.
干预措施: Coaching Session (Behavioral)
结局指标
主要结局
Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention
时间窗: Baseline to 8 weeks post-intervention
Assessed by the Insomnia Severity Index, a 7-item measure measuring insomnia over the previous two weeks with answers graded on a 5-point Likert scale, ranging from 0 "No Problem" to "4 "Very Severe" for a total score range of 0 to 28. A higher score reflects moderate to severe insomnia symptoms.
次要结局
- Change in Total Mood Disturbance (TMD) Scale from the Profile of Mood States - Short Form (POMS-SF) Score from Baseline to 8 weeks Post-Intervention(Baseline to 8 weeks post-intervention)
- Change in Perceived Cognitive impairment Scale from Baseline to 8 weeks Post-Intervention(Baseline to 8 weeks post-intervention)
- Change in Impact of Cognitive Function on Quality of Life Scale from Baseline to 8 weeks Post-Intervention(Baseline to 8 weeks post-intervention)
研究者
Christopher Recklitis, PhD
Principal Investigator
Dana-Farber Cancer Institute