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: 10231363
• 负责人: Hannah M Fisher
• 金额: $ 6.56万
• 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 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10231363
• 关键词: Acute Lymphocytic Leukemia; 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; Lead; Length; Link; 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; Pharmacology; 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; anxiety symptoms; arm; base; chemotherapy; cost effective; depressive symptoms; disorder risk; efficacy trial; experience; heuristics; high risk; immunosuppressed; improved; mindfulness; novel strategies; pain symptom; phase 1 study; phase 2 study; poor sleep; post intervention; primary outcome; programs; response; 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.

血液病患者发生失眠和日间疲劳、疼痛和痛苦的风险很高。 住院治疗后的几个月。延长化疗住院时间可能会激活易感因素 因素(例如，过度唤醒)和诱发不良睡眠模式。睡眠不足和随之而来的担忧 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 这会进一步加剧失眠(例如，午睡/延长卧床时间、用药)。睡眠困难可能 随着患者努力摆脱失眠及其对有价值的影响的想法，患者变得慢性 活动。慢性失眠会增加癌症患者病情进展的风险。以正念为基础 失眠治疗(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 用正念原则和冥想控制失眠，减少冥想，促进积极 对睡眠不佳的反应(例如，卧床时间减少，药物治疗减少)。到目前为止，MBTI还没有应用于 特别容易出现夜间和白天睡眠障碍的血液病患者 在住院化疗出院后的几个月里感到疲倦、疼痛和痛苦。对MBTI的适应 有必要更好地解决免疫抑制的血液病患者面临的独特挑战 在要求住院治疗后出现失眠、疲劳、疼痛和痛苦。拟议的研究旨在 调整和评估MBTI方案，其中包括基于正念的睡眠技术和应对训练 白天疲劳、疼痛和痛苦的技能。参与者将为血液病患者代言 住院化疗出院后1-4周出现失眠、乏力、疼痛和苦恼。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来调整MBTI以适应个人 治疗和改善症状管理。将进一步细化干预内容和程序 通过迭代用户测试(N=5)。我们假设这些活动将导致一个手工化的、适应的MBTI 协议包括患者材料和结构化的治疗师手册，以使干预标准化。第二阶段 旨在进行单臂试点研究(N=30)，以评估可行性、可接受性，并检查Pre-to 干预后的结果。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、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 国家癌症研究所的使命是减少癌症的痛苦，该项目启动了一个项目， 研究集中在未被充分研究的血液系统癌症人群的关键症状管理需求上。 这项研究的积极结果将为更大规模、方法上严格的随机调查提供支持 疗效试验。未来的工作可能会检验适应的MBTI对神经内分泌和免疫标记物的影响 这与睡眠有关，并与癌症的进展有关。