Sleep Treatment Education Program (STEP-1): An Online Educational Intervention for Insomnia in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Insomnia Severity Change at 8 Weeks
研究概览
简要总结
The purpose of the study is to learn if single session online education programs can help improve cancer survivors' sleep.
详细描述
This study is a randomized controlled trial of cancer survivors with clinically significant symptoms of insomnia to evaluate the efficacy of the cognitive-behavioral intervention Sleep Treatment Education Program-1 (STEP-1).
Participants in this study will be randomized to either the behavioral education session, Sleep Treatment Education Program-1 (STEP-1), which will instruct them on how to make changes to their sleep habits and behaviors or an enhanced usual care control program which will provides them with access to online relaxation programs and instruct them about how these programs can help improve sleep.
Participation in the study involves:
- Taking part in a 60-90 minute, one-on-one session using the Zoom video conference platform and completing a brief online questionnaires.
- Completing an approximately 10 minute follow-up questionnaire online with a brief phone call 4, and 8 weeks after the education session. An additional optional insomnia questionnaire will be requested at one month after the 8 week follow-up.
- Participants will receive a $25 gift card upon completing 4 & 8 week questionnaires.
It expected that about 70 people will take part in this study.
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
- None
入排标准
- 年龄范围
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-89
- •History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year 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 ≥12
- •Regular access to the internet on a daily basis
- •Able to read and write in English
排除标准
- •Survivors who report ever being diagnosed with Bipolar Disorder.
- •Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months.
- •Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia during the study period.
- •Survivors diagnosed with sleep apnea who have declined treatment or are not adherent with treatment (as assessed by screening questions, see Appendix A).
- •Survivors with suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A).
- •Usual bedtime does not fall between 5:00 pm and 5:00 am.
- •Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel across time zones, or employment in a position that could impact public safety (such as air traffic-controller, operating heavy machinery)
- •Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.
- •Prior participation in a research study which provided an educational or behavioral intervention for insomnia.
- •Prior participation in a behavioral treatment or patient education program for insomnia delivered at the Dana-Farber Cancer Institute, or at Boston Children's Hospital.
- •Participation in behavioral or educational interventions for insomnia in the 2 years prior to enrollment. This includes in-person as well as synchronous and asynchronous online insomnia programs, but not independent use of books, workbooks or other written self-help materials addressing insomnia.
研究组 & 干预措施
Sleep Treatment Education Program (STEP-1)
Prior to being randomized, all participants will complete health questionnaires.
Participants assigned to the Sleep Treatment Education Program (STEP-1) group will receive online instruction on making changes to sleep habits and health behaviors.
Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires.
干预措施: Sleep Treatment Education Program (STEP-1) (Behavioral)
Enhanced Usual Care: Relaxation Education
Prior to being randomized, all participants will complete health questionnaires.
Participants assigned to the Enhanced Usual Care group will receive information on relaxation techniques to improve sleep
Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Insomnia Severity Change at 8 Weeks
时间窗: Baseline to 8 weeks
The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
次要结局
- Profile of Mood States Change at 8 Weeks(Baseline to 8 weeks)
- Profile of Mood States Change at 4 Weeks(Baseline to 4 weeks)
- Change in Sleep Quality(Baseline to 8 Weeks)
- Sleep Duration(Administered at 8 week follow-up)
- Insomnia Severity Change at 4 Weeks(Baseline to 4 Weeks)
研究者
Christopher Recklitis, PhD
Principal Investigator
Dana-Farber Cancer Institute