Mindfulness and Cognitive Behavioral Therapy for Sleep in Cancer

癌症睡眠的正念和认知行为疗法

• 批准号: 10599911
• 负责人: Hannah M Fisher
• 金额: $ 1.82万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10599911
• 关键词: Acute; Acute Myelocytic Leukemia; Address; Anxiety; Beds; Behavior; Behavior Therapy; Behavioral Symptoms; Cancer Patient; Chronic; Chronic Disease; Chronic Insomnia; Client satisfaction; Cognitive; Cognitive Therapy; Combined Modality Therapy; Coping Skills; Disease Progression; Disease remission; Distress; Exacerbated Insomnia; Exercise; Expert Opinion; Family; Fatigue; Focus Groups; Foundations; Future; Goals; Hematologic Neoplasms; Home; Hospitalization; Immunocompromised Host; Immunologic Markers; Individual; Inpatients; Intervention; Learning; Length; Link; Lymphoblastic lymphoma; Malignant Neoplasms; Manuals; Meditation; Mental Depression; Methodology; Mindfulness Training; Mission; Napping; National Cancer Institute; Neurosecretory Systems; Non-Hodgkin' s Lymphoma; Outcome; Pain; Participant; Patients; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Predisposing Factor; Procedures; Process; Protocols documentation; Provider; Questionnaires; Randomized; Reporting; Research; Research Personnel; Scanning; Self Efficacy; Severities; Sleep; Sleep disturbances; Sleeplessness; Standardization; Stimulus; Structure; Survival Rate; Symptoms; Techniques; Testing; Thinking; Time; Training; Vulnerable Populations; Work; acceptability and feasibility; anxiety symptoms; arm; chemotherapy; cost effective; depressive symptoms; disorder risk; efficacy trial; experience; heuristics; high risk; immunosuppressed; improved; information gathering; leukemia/lymphoma; mindfulness; novel strategies; pain symptom; pharmacologic; phase 1 study; phase 2 study; pilot test; poor sleep; post intervention; primary outcome; programs; response; rumination; satisfaction; secondary outcome; skills; sleep difficulty; sleep pattern; sleep quality; symptom management; symptomatic improvement; theories; tumor progression

Hematologic cancer patients are at high risk for developing insomnia and daytime fatigue, pain, and distress in the months after inpatient treatment. Extended hospitalization for chemotherapy can activate predisposing factors (e.g., hyperarousal) and precipitate poor sleep patterns. Lack of sleep and subsequent worry about poor sleep quality may negatively impact daytime fatigue, pain, and distress, and lead to problematic behaviors that further exacerbate insomnia (e.g., napping/extended time in bed, medication use). Sleep difficulties can become chronic as patients struggle to disengage from thoughts about insomnia and its interference to valued activities. Chronic insomnia places cancer patients at elevated risk for disease progression. Mindfulness-Based Therapy for Insomnia (MBTI) is new group-based treatment that combines sleep restriction and stimulus control with mindfulness principles and meditations to treat insomnia, reduce rumination, and promote positive responses to poor sleep (e.g., less time in bed, less medication). To date, MBTI has not been applied to hematologic cancer patients who are particularly prone to both nighttime sleep disturbance and daytime fatigue, pain, and distress in the months following discharge from inpatient chemotherapy. Adaptations to MBTI are warranted to better address the unique challenges facing immunosuppressed hematologic cancer patients with insomnia, fatigue, pain, and distress after demanding inpatient treatments. The proposed study seeks to adapt and assess an MBTI protocol that includes mindfulness-based sleep techniques and training in coping skills for daytime fatigue, pain, and distress. Participants will be hematologic cancer patients endorsing insomnia, fatigue, pain, and distress 1-4 weeks after discharge from inpatient chemotherapy. Phase I aims to use information gathered from patient (N=3) and provider (N=1) focus groups to adapt MBTI for individual treatment and improved symptom management. Intervention content and procedures will be further refined through iterative user testing (N=5). We hypothesize these activities will result in a manualized, adapted MBTI protocol including patient materials and a structured therapist manual to standardize the intervention. Phase II aims to conduct a single-arm pilot study (N=30) to assess the feasibility, acceptability, and examine pre- to post-intervention outcomes. We hypothesize that participants will report improvement in the primary outcome of insomnia symptoms (i.e., severity and interference) and secondary outcomes (i.e., fatigue, pain, anxiety and depressive symptoms, hyperarousal, mindfulness, and self-efficacy for symptom management). Consistent with the National Cancer Institute’s mission to reduce suffering from cancer, this project initiates a program of research focused on critical symptom management needs for the understudied hematologic cancer population. Positive results from this study would provide support for a larger, methodologically rigorous randomized efficacy trial. Future work might examine the effects of adapted MBTI on neuroendocrine and immune markers that are linked to sleep and have implications for cancer progression.

血液学癌症患者患失眠和白天疲劳，疼痛和困扰的高风险 住院治疗后的几个月。化学疗法的延长住院可能会激活易感性 因素（例如，高阳光），沉淀出不良的睡眠模式。缺乏睡眠，随后担心 睡眠质量差可能会对白天的疲劳，疼痛和困扰产生负面影响，并导致有问题的行为 这进一步加剧了失眠症（例如，床上小睡/延长时间，使用药物）。睡眠困难可以 随着患者努力使人们对失眠的想法及其干扰的重视，随着患者努力脱离感 活动。慢性失眠使癌症患者患疾病进展的风险升高。基于正念 失眠治疗（MBTI）是新的基于组的治疗方法，结合了睡眠限制和刺激 用正念原则和冥想来控制失眠，减少反省并促进积极 对睡眠不良的反应（例如，床上的时间更少，药物较少）。迄今为止，MBTI尚未应用于 血液学癌症患者特别容易患夜间睡眠障碍和白天 住院化疗后出院后的几个月，疲劳，疼痛和困扰。适应MBTI 有必要更好地解决免疫抑制血液学癌症患者面临的独特挑战 需要住院治疗后失眠，疲劳，疼痛和困扰。拟议的研究试图 适应和评估MBTI协议，其中包括基于正念的睡眠技术和应对方面的培训 白天疲劳，疼痛和困扰的技能。参与者将是认可的血液学癌症患者 入院后1-4周失眠，疲劳，疼痛和困扰。第一阶段的目标 使用从患者（n = 3）和提供者（n = 1）焦点组收集的信息来适应个人 治疗并改善症状管理。干预内容和程序将进一步完善 通过迭代用户测试（n = 5）。我们假设这些活动将导致手动，适应的MBTI 包括患者材料和结构化治疗师手册的协议，以标准化干预措施。第二阶段 旨在进行单臂试验研究（n = 30），以评估可行性，可接受性并检查预先 干预后结果。我们假设参与者将报告主要结果的改善 失眠症状（即严重程度和干扰）和次要结果（即疲劳，疼痛，动画和 抑郁症状，过度，正念和症状管理的自我效能感）。持续的 随着国家癌症研究所减少癌症苦难的使命，该项目启动了一个计划 研究的重点是对知识的血液学癌症人群的关键症状管理需求。 这项研究的积极结果将为更大的，方法上严格的随机分析提供支持 有效试验。未来的工作可能会检查改编后的MBTI对神经内分泌和免疫标记的影响 与睡眠有关，对癌症的进展有影响。