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: 10686464
• 负责人: Hannah M Fisher
• 金额: $ 0.25万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10686464
• 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.

血液癌症患者在治疗过程中有发生失眠、白天疲劳、疼痛和痛苦的高风险。 住院治疗后的几个月化疗延长住院时间可激活易感性 因素（例如，过度觉醒）并引发不良的睡眠模式。睡眠不足和随后的担忧 睡眠质量差可能会对白天的疲劳、疼痛和痛苦产生负面影响，并导致问题行为 这进一步加剧了失眠（例如，午睡/长时间卧床，药物使用）。睡眠困难可以 由于患者努力摆脱失眠的想法及其对价值的干扰， 活动慢性失眠使癌症患者的疾病进展风险增加。正念 MBTI是一种新的基于群体的治疗方法，它结合了睡眠限制和刺激 控制与正念原则和冥想治疗失眠，减少反刍，并促进积极的 对睡眠不好的反应（例如，少卧床，少吃药）。到目前为止，MBTI还没有应用于 血液癌症患者特别容易出现夜间睡眠障碍和白天睡眠障碍， 从住院化疗出院后数月内的疲劳、疼痛和痛苦。适应MBTI 有必要更好地解决免疫抑制血液肿瘤患者面临的独特挑战， 失眠、疲劳、疼痛和痛苦，要求住院治疗后。拟议的研究旨在 调整和评估MBTI协议，包括基于正念的睡眠技术和应对培训 应对白天疲劳、疼痛和痛苦的技能。参与者将是血液癌症患者， 从住院化疗出院后1-4周出现失眠、疲劳、疼痛和痛苦。第一阶段的目标是 使用从患者（N=3）和提供者（N=1）焦点小组收集的信息， 治疗和改善症状管理。干预内容和程序将进一步细化 通过迭代用户测试（N=5）。我们假设这些活动将导致一个手动的，适应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。二期 目的是进行一项单臂试点研究（N=30），以评估可行性，可接受性，并检查前， 干预后的结果。我们假设参与者将报告主要结局的改善 失眠症状（即，严重性和干扰）和次要结果（即，疲劳、疼痛、焦虑和 抑郁症状、过度觉醒、正念和症状管理的自我效能）。一致 随着国家癌症研究所的使命，以减少癌症的痛苦，这个项目发起了一个计划， 研究集中在未充分研究的血液癌症人群的危急症状管理需求上。 这项研究的积极结果将为更大规模的、方法上严格的随机化研究提供支持。 功效试验未来的工作可能会检查适应MBTI对神经内分泌和免疫标志物的影响 与睡眠有关并对癌症进展有影响。