The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients

乳腺癌患者 CBT-I 剂量、睡眠时间和疲劳之间的关系

基本信息

批准号：
10433647
负责人：
Michael Lloyd Perlis
金额：
$ 41.78万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-23 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10433647
关键词：
Address Adherence Affect Age Architecture Behavior Therapy Behavioral Mechanisms Breast Cancer Patient Breast Cancer survivor Cancer Patient Cancer Survivor Cancer Survivorship Chronic Cognitive Cognitive Therapy Collaborations Conditioned Insomnia Data Diagnosis Dose Drowsiness Emotional Enrollment Faculty Fatigue Feasibility Studies Fibrinogen Goals High Prevalence Innate Immune System Investigation Malignant Neoplasms Medical Morale Morbidity - disease rate Oncology Outcome Pathologic Patients Pilot Projects Postdoctoral Fellow Primary Insomnia Process Quality of life Radiation therapy Randomized Recovery Regimen Research Resolution Rest Sampling Sleep Sleeplessness Stress Symptoms Time Titrations cancer recurrence cancer therapy cohort disabling symptom experience falls immune function improved malignant breast neoplasm persistent symptom primary outcome programs recruit sleep onset sleep quality sleep quantity standard care statistics survivorship targeted treatment

项目摘要

Contact PD/PI: Perlis, Michael (w/ Muench, Alexandria) ABSTRACT (PROJECT SUMMARY) Insomnia and fatigue commonly occur during and/or after cancer treatment. While variable by diagnosis and stage of illness, 30-60% of cancer patients endorse difficulty initiating and/or maintaining sleep and 50-90% endorse fatigue. Despite these high prevalence rates, and the substantial overlap in occurrence, most research related to cancer-related fatigue (CRF) has assessed this pervasive and persistent symptom in a manner that does not take into account sleep quality and quantity. This is, in part, due to the definition of CRF as “pathological levels of persistent physical, emotional, and/or cognitive ‘enervation’ that appear not to be relieved, or improved by, rest or sleep”. To date only a few studies have evaluated whether behavioral treatments such as Cognitive Behavioral Therapy for Insomnia (CBT-I) can provide some relief to patients who are experiencing CRF. The effect sizes for CBT-I outcomes, in the context of cancer, have been found to be comparable to those observed in “primary insomnia”. The findings with respect to CBT-I effects on CRF have been more modest. The smaller effects of CBT-I on CRF may be due to a variety of factors, but one simple possibility is that CBT-I is under-dosed for patients with cancer. In other words, subjects with cancer may require more sessions to achieve sleep durations that can affect daytime fatigue. Accordingly, we propose to evaluate the association between CBT-I dose (Low dose [4 or 8 sessions] or High Dose [10 or 12 sessions]) and changes in sleep duration and CRF. The study will enroll 70 subjects to obtain an analysis sample of 60 subjects. Subjects will be diagnosed with breast cancer and will be between the ages of 25-85 (inclusive). In order to allow age to be an analyzable factor, recruitment will be stratified so that the following cohorts are equally populated (i.e., 25-45, 45-65, 65-85). The focus of the R21 study will be on feasibility. The primary outcomes will be related to recruitment, subject adherence, treatment acceptability, and subject retention. Descriptive data will also be obtained to examine whether high dose CBT-I (i.e., larger improvements in sleep efficiency and/or sleep duration) positively affects CRF. The study will be undertaken in collaboration with our program post doc (Dr. Muench) as she transitions to Jr. Faculty and pursues this program of research on a more independent basis. The study collaborators will also include: Dr. Knashawn Morales (statistics); Dr. Sheila Garland (psycho-oncology & sleep); and Dr. Donn Posner (CBT-I).

联系 PD/PI：Perlis, Michael（与慕尼黑、亚历山大）摘要（项目概要）失眠和疲劳通常发生在癌症治疗期间和/或之后，但因情况而异。诊断和疾病阶段，30-60% 的癌症患者表示难以启动和/或尽管患病率很高，但仍有 50-90% 的人认可保持睡眠和疲劳。发生的情况有很大重叠，大多数与癌症相关疲劳 (CRF) 相关的研究都以一种没有考虑到这种普遍且持续的症状的方式评估这在一定程度上是由于 CRF 的定义是“病理水平的睡眠”。持续的身体、情感和/或认知“衰弱”似乎没有得到缓解，或迄今为止，只有少数研究评估了行为是否可以改善。失眠认知行为疗法 (CBT-I) 等治疗可以在一定程度上缓解失眠症状正在经历 CRF 的患者在癌症背景下 CBT-I 结果的效应大小，已发现与“原发性失眠”中观察到的结果相当。就 CBT-I 对 CRF 的影响而言，CBT-I 对 CRF 的影响较小。可能是由于多种因素造成的，但一个简单的可能性是 CBT-I 的剂量不足换句话说，癌症患者可能需要更多的疗程才能实现。因此，我们建议评估可能影响白天疲劳的睡眠持续时间。 CBT-I 剂量之间的关联（低剂量 [4 或 8 次疗程] 或高剂量 [10 或 12 次疗程]）以及睡眠持续时间和 CRF 的变化该研究将招募 70 名受试者进行分析。 60 名受试者的样本将被诊断患有乳腺癌，并且将在 60 名受试者之间进行。年龄在25-85岁（含）为了让年龄成为一个可分析的因素，招聘将分层，以便以下群组的人口数量相等（即 25-45、45-65、65-85）。 R21 研究的主要结果将与招募、主题有关。还将获得依从性、治疗可接受性和受试者保留率。检查高剂量 CBT-I（即睡眠效率和/或睡眠的较大改善）是否持续时间）对 CRF 产生积极影响该研究将与我们的项目合作进行。博士后（Muench 博士），她转为初级教师并从事该研究项目该研究的合作者还包括：Knashawn Morales 博士。（统计）；Sheila Garland 博士（心理肿瘤学和睡眠）；Donn Posner 博士（CBT-I）。