Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 249
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with stage I-IV cancer who are receiving cancer treatment. Cancer treatment can cause side effects such as sleep problems. Sleep problems such as insomnia, are common for cancer patients. Insomnia can be described as difficulty falling asleep, waking up many times during the night or waking up earlier than patient would like. Insomnia can increase fatigue and worsen quality of life. This trial may help researchers determine which treatment works better in reducing insomnia, BBT-CI or HEAL.
详细描述
PRIMARY OBJECTIVE:
I. Determine the efficacy of BBT-CI compared to HEAL for treating insomnia as measured by the Insomnia Severity Index (ISI) at post-intervention.
SECONDARY OBJECTIVE:
I. Determine the efficacy of BBT-CI compared to HEAL for improving sleep efficiency as measured via actigraphy at post-intervention.
MECHANISTIC OBJECTIVE:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
After completion of all baseline assessments, the coordinator will tell the study participant which group they are in but will not reveal which intervention is hypothesized to have a greater effect on insomnia. Both interventions will be presented with equipoise. The investigator and the statistical team will be blinded to the intervention group. The rest of the study staff will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years of age
- •Be diagnosed with cancer (stage I, II, III, or IV) with a life expectancy of at least 12 months
- •Be currently receiving any cancer treatment (surgery alone is excluded)
- •Report sleep disturbance of 3 or greater on the sleep disturbance question: "Rate your sleep disturbance in the past 2 weeks on a scale from 0-10, 0 is no problems and 10 is having the most severe problems"
- •Have a score of 2, 1, or 0 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
- •Be able to speak, understand and read English to participate in the study assessments and interventions
排除标准
- •Have a clinical diagnosis of obstructive sleep apnea or restless leg syndrome (even if controlled)
- •Be engaged in a formal cognitive behavioral therapy for insomnia program presently or in the past 30 days. Use of sleep medications are allowed
研究组 & 干预措施
Group I (BBT-CI)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
干预措施: Behavioral Intervention (Behavioral)
Group I (BBT-CI)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
干预措施: Electronic Health Record Review (Other)
Group I (BBT-CI)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
干预措施: Quality-of-Life Assessment (Other)
Group I (BBT-CI)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
干预措施: Questionnaire Administration (Other)
Group II (HEAL)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
干预措施: Behavioral Intervention (Behavioral)
Group II (HEAL)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
干预措施: Electronic Health Record Review (Other)
Group II (HEAL)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
干预措施: Questionnaire Administration (Other)
Group II (HEAL)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: post intervention
Will evaluate the mean between arm difference in ISI score change from time point baseline to post-intervention. To assess this, will use analysis of covariance model with ISI at post-intervention as the outcome, study arm (group) as a fixed effect and baseline ISI as a covariate. Will test baseline group interaction.
次要结局
- Sleep efficiency(post intervention)
- Circadian phenomena(Up to 6 months post intervention)
研究者
Karen Mustian
Study Co-Chair
University of Rochester