Feasibility, Acceptability and Mechanisms of Brief Behavioral Therapy (BBT) for Sleep Problems During Chemotherapy: A Phase II Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gary Morrow
- 入组人数
- 71
- 试验地点
- 12
- 主要终点
- Percentage of Key Components of BBT Delivered by NCI Community Oncology Research Program (NCORP) Staff, Assessed by Checklist and Auditing of Audio-recordings
研究概览
简要总结
This randomized phase II trial studies how well brief behavioral therapy works in improving sleep disorders in patients with stage I-III breast cancer undergoing chemotherapy. Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life in patients with breast cancer who are undergoing chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. Determine recruitment rates to the proposed randomized controlled trial (RCT).
II. Determine the rate of intervention adherence. III. Determine the feasibility of training National Cancer Institute (NCI) Community Oncology Research Program (NCORP) clinical research staff to successfully deliver the Brief Behavioral Therapy (BBT) intervention.
SECONDARY OBJECTIVES:
I. Obtain preliminary estimates for the effect of the intervention (compared with control) on insomnia as measured by the Insomnia Severity Index (ISI).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed breast cancer (stage I, II, III)
- •Be receiving chemotherapy in either weekly, 2-week or 3-week cycles and have at least 6 weeks of chemotherapy treatment remaining; patients are eligible any time before chemotherapy cycle 3 if on a 2- or 3-week cycle, or cycle 4 if on a 1-week cycle; (Note: use of biologics [e.g., Herceptin (trastuzumab)] is permitted)
- •For patients on a weekly regimen, there should be at least 3 dosages of chemotherapy remaining
- •For patients on either a 2 week or 3 week cycle, there should be at least 2 dosages of chemotherapy remaining
- •Patients will not be dropped from the study if their chemotherapy is discontinued after they are enrolled
- •Report sleep disturbance of 8 (sum total of all 7 items) or greater on the Insomnia Severity Index
- •(Note: this measure will be repeated again at baseline assessment)
- •Report sleep problems that began or got worse with the diagnosis of cancer or with chemotherapy; (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?)
- •Be able to speak and read English
- •Patients can take sleep aids (e.g., hypnotics and sedatives) for insomnia if they use sleep aids as needed; patients taking sleep aids every night are excluded; use of melatonin every night is permitted and these patients are not excluded
- •Be able and willing to wear an Actiwatch for the entire 24 hours of each day they are scheduled to wear it
排除标准
- •Have diagnosis of breast cancer stage IV
- •Have sleep problems that began before diagnosis and have not changed since diagnosis
- •Self-report or have a medical record of an unstable comorbid medical or psychiatric condition that would make it unsafe or impossible to adhere to the study protocol
- •Have a clinical diagnosis of sleep apnea or restless leg syndrome
- •Be unable or unwilling to discontinue anxiolytic medication within 4 hours of intervention sessions
- •Take medication for sleep (e.g., hypnotics and sedatives) every night; melatonin is permitted
- •Patients who are shift workers are excluded; shift worker is defined as someone who has irregular work and sleep hours (such as working a non-traditional schedule: e.g., 4pm-midnight or 10pm-6am; a rotating schedule e.g., alternating between day and night shifts, or starting work between 4am and 7am)
- •Have an implanted device for heart failure (e.g., pacemaker, defibrillator, left ventricular assist device, etc.)
结局指标
主要结局
Percentage of Key Components of BBT Delivered by NCI Community Oncology Research Program (NCORP) Staff, Assessed by Checklist and Auditing of Audio-recordings
时间窗: Up to 1 month
Each NCORP staff person completed a study checklist in which they designated which concepts they discussed with the patient at each session. Concepts included how sleep problems develped, how to control stimulus, and sleeping environment. The overall mean percent delivery was measured using a random effects model (residual maximum likelihood \[REML\] estimation), where the intercept represents the mean delivery and three independent random effects are included. Because of the small sample size, testing will use the Kenward-Roger procedure.
Percentage of Eligible Patients Consented
时间窗: baseline
Will be evaluated by calculating the specific percentage (with 95% confidence interval) of the total number of participants approached that then consented and enrolled in the study.
Percentage of Consented Participants Who Complete the Study, Defined as Completion of at Least 5 BBT
时间窗: Up to 1 month
Will be evaluated by calculating the specific percentage (with 95% confidence interval) and performing an exact binomial test with the null hypothesis being greater than or equal to 75%.
次要结局
- Change in Circadian Rhythm Amplitude Over 12 Hours(baseline to up to 1 month)
- Change in Mean Circadian Rhythm Acrophase Over 24 Hours(baseline to up to 1 month)
- Change in Mean Circadian Rhythm Acrophase Over 12 Hours(baseline to up to 1 month)
- Change in Insomnia as Measured by the Insomnia Severity Index (ISI)(Baseline to up to 1 month)
- Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)(Baseline to up to 1 month)
- Change in Circadian Rhythm Amplitude Over 24 Hours(baseline to up to 1 month)
- Change in Mean Circadian Rhythm Mesor(Baseline to up to 1 month)
研究者
Gary Morrow
Director
University of Rochester NCORP Research Base