Feasibility of Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- fatigue
研究概览
简要总结
Women with breast cancer complain of poor sleep and fatigue during chemotherapy which affect their mood, their memory and their quality of life. The investigators are testing whether it is feasible to treat the poor sleep and fatigue with behavioral treatments, before the start of chemotherapy and whether improving sleep and fatigue will also improve mood, memory and quality of life.
详细描述
Women with breast cancer (BC) report poor sleep and fatigue, occasionally before, and often during chemotherapy. These symptoms often last for months and even years after the end of cancer treatment, significantly burdening the patients' quality of life (QOL), decreasing their overall functional level and potentially hindering the patients' re-integration into productive society. Improvement in the domains of sleep and fatigue might result in overall improvement in QOL. The investigators have shown that women with breast cancer with a symptom cluster of poor sleep, fatigue and depressive symptoms before chemotherapy are more likely to manifest an increase in severity of these symptoms and decreased QOL during chemotherapy.
A randomized controlled treatment study is now warranted to examine whether concurrent treatment of sleep and fatigue, begun before chemotherapy and continuing during chemotherapy, will prevent deterioration of sleep and fatigue during chemotherapy, and since poor sleep and fatigue are related to mood, whether these improvements will then lead to improvements in the symptom cluster of sleep/fatigue/mood as well as in QOL and cognitive functioning during chemotherapy. Before a full study can be initiated, the investigators propose a pilot study to examine the feasibility of conducting this type of treatment study.
The main aims of this pilot study are:
AIM 1: To examine whether the investigators can recruit 20 women with newly diagnosed breast cancer, before they begin chemotherapy, whether or not they are currently experiencing poor sleep and fatigue, into a treatment study that aims at preventing or mitigating poor sleep, fatigue, depressive symptoms during chemotherapy.
AIM 2: To examine whether women recruited into this study will be compliant with the sleep/fatigue treatment for a full four cycles of chemotherapy.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •stage I-III breast cancer referred for chemotherapy
- •English speaking
- •over age 18
排除标准
- •Pregnancy (by self-report; poor sleep and fatigue are sometimes associated with pregnancy);
- •Metastatic or unresectable breast cancer;
- •Patients who have been told they have sleep apnea, restless legs or periodic limb movements in sleep whether or not they are currently treated;
- •History of bipolar disorder or history of mania;
- •Current diagnosis of psychotic disorder;
- •Blindness or other physical or psychological impairments which would limit participation;
- •Shift workers;
- •Women with infants who still disturb the mother's sleep.
研究组 & 干预措施
Behavioral treatment
Brief behavioral treatment for insomnia and bright light Light and BBTI combined treatment for insomnia and fatigue
干预措施: Brief behavioral treatment for insomnia and bright light (Behavioral)
Treatment-as-usual
Treatment as usual for fatigue and insomnia
干预措施: treatment as usual (Behavioral)
结局指标
主要结局
fatigue
时间窗: 12 weeks
Change in fatigue from pre-chemotherapy to post cycle 4 chemotherapy
次要结局
- sleep(12 weeks)
研究者
Sonia Ancoli-Israel
Professor
University of California, San Diego