Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): An Online Educational Intervention for Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 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 a single online education session, with or without individualized coaching sessions, can help improve young adult cancer survivors' (YACS) sleep.
The name of the study intervention is Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).
详细描述
This study is a randomized controlled trial of young adult cancer survivors with clinically significant symptoms of insomnia to evaluate the cognitive-behavioral based Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).
All participants will take part in a single STEP-YA session, during which they will complete baseline measures prior to randomization and then receive the STEP-YA intervention. Participants will then be randomly assigned to receive the STEP-YA intervention either, 1) alone (non-coaching condition), or 2) with the addition of 2 remote coaching sessions (coaching condition). Participants will also complete follow-up measures 4 and 8 weeks post-baseline.
It expected that about 74 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be determined by patient self-report from eligibility screening with potential participants. (See Appendix A for eligibility screening materials). Participants must be screened for eligibility ≤2 weeks prior to study enrollment. Participants who are screened earlier must be rescreened within this period.
- •Age 20-39
- •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
- •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 who report being diagnosed with sleep apnea who are not receiving recommended medical treatment for their sleep apnea (as assessed by screening questions, see Appendix A).
- •Survivors who report suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A).
- •Survivors who report their 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
NON-COACHING CONDITION STEP-YA
Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
干预措施: STEP-YA without Coaching (Behavioral)
COACHING CONDITION STEP-YA
Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions.
Participates will also complete follow up questionaires at 4 and 8 weeks post baseline.
干预措施: STEP-YA with Coaching (Behavioral)
结局指标
主要结局
Insomnia Severity Change at 8 Weeks
时间窗: Baseline to 8-weeks post-intervention session
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
- Insomnia Severity Change at 4 weeks(Baseline to 4-weeks post-intervention session)
- Profile of Mood States Change at 8 weeks(Baseline to 8-weeks post-intervention session)
- Profile of Mood States Change at 4 weeks(Baseline to 4-weeks post-intervention session)
研究者
Christopher Recklitis, PhD
Principal Investigator
Dana-Farber Cancer Institute