Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified).
Participants will be randomized into 4 groups:
- Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day.
- Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day.
- Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention.
- Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.
详细描述
The purpose of this study is to test the efficacy of Brief Behavioral Treatment of Insomnia (BBT-I) in the treatment of insomnia in humans.
Insomnia is an extraordinarily common problem for cancer patients that is often associated with diminished social and vocational functioning and QOL. It is also likely that insomnia exacerbates other cancer-related symptoms (eg, fatigue, nausea, depressive mood, pain and/or reduced pain tolerance) and thus gives rise to the possibility of additive or multiplicative interactions. It is possible that untreated insomnia in the context of cancer therapy may lead to chronic forms of insomnia in cancer survivors which, in turn, independently confers risk for increased psychiatric and medical morbidity.
Thus, insomnia, by itself, is a significant problem that requires better understanding in order that its high prevalence can be reduced.
Developing interventions that might prevent onset of insomnia in breast cancer patients is vital.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BBT-I + Armodafinil
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
Armodafinil 150 mg/day by mouth.
干预措施: BBT-I (Behavioral)
BBT-I + Armodafinil
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
Armodafinil 150 mg/day by mouth.
干预措施: Armodafinil (Drug)
Behavioral placebo + Armodafinil
Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil 150 mg/day by mouth.
干预措施: Control (Behavioral)
Behavioral placebo + Armodafinil
Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil 150 mg/day by mouth.
干预措施: Armodafinil (Drug)
BBT-I without Armodafinil
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
No pharmaceutical intervention.
干预措施: BBT-I (Behavioral)
Behavioral placebo without Armodafinil
Control behavioral intervention is a sleep hygiene handout completed by participant.
No pharmaceutical intervention.
干预措施: Control (Behavioral)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: up to 32 Weeks
Insomnia Severity Index (ISI) survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows. * 0 to 7 No clinically significant insomnia * 8 to14 Subthreshold insomnia * 15 to 21 Clinical insomnia (moderate severity) * 22 to 28 Clinical insomnia (severe) ISI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean ISI score with standard deviation.
次要结局
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)(up to 32 Weeks)
研究者
Oxana Palesh
Assistant Professor of Psychiatry and Behavioral Sciences
Stanford University