Fatigue & Breast Cancer-A Behavioral Sleep Intervention

疲劳

• 批准号: 6547115
• 负责人: Ann M. Berger
• 金额: $ 31.24万
• 依托单位: UNIVERSITY OF NEBRASKA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-08-01 至 2007-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6547115
• 关键词: behavior therapy; behavioral /social science research tag; blood cell count; breast neoplasms; clinical research; counseling; exercise; fatigue; female; health behavior; health surveys; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplasm /cancer palliative treatment; outcomes research; patient oriented research; personal log /diary; psychological aspect of cancer; sleep; sleep disorders; thyrotropin; thyroxine; women's health

DESCRIPTION: (provided by applicant) Higher fatigue levels are found in women with stage I or II breast cancer receiving adjuvant chemotherapy (CT) who adopt patterns of daytime inactivity and nighttime restlessness and have more symptom and psychological distress. Interventions that improve sleep quality and reduce daytime fatigue in persons with insomnia may also benefit women receiving adjuvant CT. Using selected factors from Piper's Integrated Fatigue Model (IFM), a randomized, controlled clinical trial will compare women with breast cancer who receive a four component behavioral sleep intervention to women in the attentional control group during and after adjuvant CT. The intervention is designed to reduce fatigue in these women by promoting daytime activity, improving sleep quality and decreasing symptom and psychological distress. The aims of this study are to: 1) Compare the immediate (sleep/wake, activity/exercise, symptoms, psychological distress) and consequent (fatigue) outcomes of a four component behavioral sleep intervention (sleep hygiene counseling, relaxation therapy, sleep restriction, and stimulus control) in an experimental group (n=110) with outcomes in an attentional control group (n=110) in women with stage I or II breast cancer during 4 or 8 cycles of adjuvant CT, at 30, 60, and 90 days after their last treatment, and 1 year after their first baseline; 2) Determine the extent to which factors selected from the IFM influence fatigue intensity levels a) in the total sample and 1 year after the first treatment and 3) Evaluate the adherence to the refined behavioral sleep intervention and preferences for sleep hygiene and relaxation therapy techniques in the experimental group over time. Women will be randomized on the basis of good or poor sleeping history and intent to treat (4 versus 8 cycles of CT) to an experimental or attentional control group. Using the co-scientist model, the experimental group will follow an Individual Sleep Promotion Plan negotiated with the investigator with regularly scheduled reinforcements and revisions. The control group will receive equal time and attention regarding general topics and nutrition. Established instruments include the Piper Fatigue scale, Hospital Anxiety and Depression Scale, SF-36 Health Survey, Symptoms Experience Scale, Daily Diary and Insomnia Severity Index. Objective measures include wrist actigraphs, hemoglobin/hematocrit, white blood count, T4 and TSH, and body mass index. Statistical analyses include RM-ANOVA, generalized estimation equation methodology and multiple regression analysis. Results may inform development of clinical guidelines for fatigue management during adjuvant CT.

描述：（由申请人提供）在接受I或II期乳腺癌的女性接受辅助化疗（CT）的女性中发现了较高的疲劳水平，这些疗程是采用白天不活动和夜间不安的模式，并且有更多的症状和心理困扰。 改善睡眠质量并减轻失眠患者白天疲劳的干预措施也可能使接受辅助CT的妇女受益。 使用Piper综合疲劳模型（IFM）中选定的因素，一项随机，受控的临床试验将比较乳腺癌的女性，这些妇女在辅助CT期间和之后接受注意力对照组的四个成分行为睡眠干预与女性。 该干预措施旨在通过促进白天活动，改善睡眠质量并减轻症状和心理困扰，来减轻这些女性的疲劳。 这项研究的目的是：1）比较四分之性的行为睡眠干预措施（睡眠卫生咨询，放松疗法，睡眠限制，在辅助对照组（n = 110）的实验组（n = 110）中，在4或8个辅助CT期间，在患有I期或II期乳腺癌的女性中，在30、60和8个周期期间，在患有I期或II期乳腺癌的女性中的结果（n = 110），在30、60和他们上次治疗后的90天，以及第一个基线后的1年； 2）确定从IFM中选择的因素影响疲劳强度水平的程度a）在总样本中以及第一次治疗后的1年和3）评估对精致行为睡眠干预的依从性以及睡眠卫生和放松治疗技术的偏好随着时间的流逝，实验组。 妇女将根据良好或不良的睡眠病史随机分配（4次与8个周期）与实验或注意对照组。 使用共同科学的模型，实验组将遵循与调查员进行定期安排的增援和修订的个人睡眠促进计划。 对照组将获得有关一般主题和营养的同等时间和关注。 已建立的工具包括吹笛者疲劳量表，医院焦虑和抑郁量表，SF-36健康调查，症状经验量表，日记和失眠严重程度指数。 客观措施包括腕部表演，血红蛋白/血细胞比容，白血计数，T4和TSH以及体重指数。 统计分析包括RM-ANOVA，广义估计方程方法和多元回归分析。 结果可能会为辅助CT期间疲劳管理临床指南的制定提供信息。