MBSR Symptom Cluster Trial for Breast Cancer Survivors

针对乳腺癌幸存者的 MBSR 症状群试验

基本信息

批准号：
8151700
负责人：
Cecile A Lengacher
金额：
$ 8.44万
依托单位：
UNIVERSITY OF SOUTH FLORIDA
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-02-01 至 2013-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8151700
关键词：
Acute-Phase Proteins Adhesives Adjuvant Adrenal Cortex Adrenal Cortex Hormones Adrenal Glands Adrenal Medulla Adrenergic Receptor Affect Aftercare Anti-Inflammatory Agents Anti-inflammatory Antibody Formation Anxiety Arousal Awareness B-Lymphocytes Behavior Biological Biological Markers Breast Breast Cancer Treatment CD19 gene Cancer Patient Cancer Survivor Catecholamines Cell Adhesion Cell Adhesion Molecules Cells Characteristics Circadian Rhythms Clinical Cognition Cognitive Complement Corticotropin-Releasing Hormone Cytotoxic T-Lymphocytes Data Devices Disease Distress Dose Elements Emotional Emotions Endothelial Cells Epinephrine Equilibrium Family Fatigue Frequencies Fright Functional disorder Glucocorticoids Goals Grouping Health Hormones Hydrocortisone Hypothalamic structure ICAM1 gene Immune Immune response Individual Inflammation Inflammation Mediators Inflammatory Interleukin-1 Interleukin-10 Interleukin-2 Interleukin-4 Interleukin-6 Intervention Leukocytes Life Literature Logic Lymphocyte Lymphocyte Subset Malignant Neoplasms Malignant neoplasm of prostate Mastectomy Measures Mediating Mediator of activation protein Medical Meditation Memory Mental Depression Modeling Moods Morbidity - disease rate NCAM1 gene Nervous system structure Neuraxis Neurosecretory Systems Norepinephrine Nursing Research Organ Outcome Pain Parasympathetic Nervous System Pathway interactions Patients Pattern Peripheral Persons Phagocytosis Pilot Projects Pituitary Gland Play Population Prevalence Probability Process Production Property Quality of life Radiation Randomized Randomized Clinical Trials Recurrence Regimen Relaxation Reporting Research Residual state Role SELL gene Secondary to Sensitivity and Specificity Signal Transduction Sleep Sleep disturbances Social support Staging Stress Subgroup Survivors Sympathetic Nervous System Symptoms System T-Lymphocyte TNF gene Testing Time Training Treatment Protocols Vascular Permeabilities Woman Yoga base biobehavior biological adaptation to stress breast lumpectomy cancer recurrence cancer type chemotherapy chronic pain cytokine depressive symptoms disturbance in affect effective intervention equilibration disorder experience granulocyte heuristics hydrocortisone receptor hypothalamic-pituitary-adrenal axis immune function improved innovation intercellular cell adhesion molecule intervention effect macrophage malignant breast neoplasm mindfulness mindfulness-based stress reduction monocyte optimism patient population post intervention programs psychologic psychosocial public health relevance response survivorship symptom management treatment as usual

Acute-Phase Proteins Adhesives Adjuvant Adrenal Cortex Adrenal Cortex Hormones Adrenal Glands Adrenal Medulla Adrenergic Receptor Affect Aftercare Anti-Inflammatory Agents Anti-inflammatory Antibody Formation Anxiety Arousal Awareness B-Lymphocytes Behavior Biological Biological Markers Breast Breast Cancer Treatment CD19 gene Cancer Patient Cancer Survivor Catecholamines Cell Adhesion Cell Adhesion Molecules Cells Characteristics Circadian Rhythms Clinical Cognition Cognitive Complement Corticotropin-Releasing Hormone Cytotoxic T-Lymphocytes Data Devices Disease Distress Dose Elements Emotional Emotions Endothelial Cells Epinephrine Equilibrium Family Fatigue Frequencies Fright Functional disorder Glucocorticoids Goals Grouping Health Hormones Hydrocortisone Hypothalamic structure ICAM1 gene Immune Immune response Individual Inflammation Inflammation Mediators Inflammatory Interleukin-1 Interleukin-10 Interleukin-2 Interleukin-4 Interleukin-6 Intervention Leukocytes Life Literature Logic Lymphocyte Lymphocyte Subset Malignant Neoplasms Malignant neoplasm of prostate Mastectomy Measures Mediating Mediator of activation protein Medical Meditation Memory Mental Depression Modeling Moods Morbidity - disease rate NCAM1 gene Nervous system structure Neuraxis Neurosecretory Systems Norepinephrine Nursing Research Organ Outcome Pain Parasympathetic Nervous System Pathway interactions Patients Pattern Peripheral Persons Phagocytosis Pilot Projects Pituitary Gland Play Population Prevalence Probability Process Production Property Quality of life Radiation Randomized Randomized Clinical Trials Recurrence Regimen Relaxation Reporting Research Residual state Role SELL gene Secondary to Sensitivity and Specificity Signal Transduction Sleep Sleep disturbances Social support Staging Stress Subgroup Survivors Sympathetic Nervous System Symptoms System T-Lymphocyte TNF gene Testing Time Training Treatment Protocols Vascular Permeabilities Woman Yoga base biobehavior biological adaptation to stress breast lumpectomy cancer recurrence cancer type chemotherapy chronic pain cytokine depressive symptoms disturbance in affect effective intervention equilibration disorder experience granulocyte heuristics hydrocortisone receptor hypothalamic-pituitary-adrenal axis immune function improved innovation intercellular cell adhesion molecule intervention effect macrophage malignant breast neoplasm mindfulness mindfulness-based stress reduction monocyte optimism patient population post intervention programs psychologic psychosocial public health relevance response survivorship symptom management treatment as usual

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项目摘要

DESCRIPTION (provided by applicant): Breast cancer is the most prevalent form of cancer among women. After treatment completion, breast cancer survivors frequently experience residual symptoms including pain, fatigue, sleep dysfunction, anxiety, depression, and fear of recurrence. This wide range of post-treatment symptoms, and possibly concomitant stress-related cytokine responses, may occur in combination (clusters). Effective interventions for this understudied group of cancer survivors are paramount given the size of this affected patient population. The primary goal of this application in response to RFA PA-07-074 for the first 2 submissions, and PA- 07-070 for this 3rd submission is to rigorously evaluate the efficacy of the Mindfulness Based Stress Reduction (MBSR) Breast Cancer (BC) program among breast cancer survivors. Specifically, we aim to determine: (1) the extent to which the MBSR (BC) program improves patient outcomes after treatment completion; (2) the manner (mechanisms) by which the MBSR (BC) program is effective; and (3) if particular subgroups of patients derive the most benefit from the MBSR (BC) program. To achieve these aims, we will conduct a randomized clinical trial of 330 women with Stage 0, I, II, and III breast cancer who have undergone lumpectomy and/or mastectomy, and are within 2 years of completion of treatment with adjuvant radiation and/or chemotherapy. This period corresponds to the critical transition time when formal medical treatment has ceased, yet residual symptoms remain. Patients will be randomly assigned in equal probability to the MBSR (BC) program or a waitlisted usual care regimen that is later offered the MBSR (BC) program. Patient assessments will be made at baseline, 6 weeks, and 12 weeks, and will include measures of psychological symptoms (depression, anxiety, perceived stress), physical symptoms (pain, fatigue, sleep dysfunction), quality of life, biological stress markers (pro-inflammatory immune cytokines, cellular adhesion molecules, lymphocyte subsets) and stress-related hormones (cortisol, catecholamines). The MBSR (BC) program to be evaluated is a clinical program that provides systematic training to promote stress reduction by self-regulating arousal to stress. Our group has modified this program for breast cancer survivors and shown preliminary evidence of its efficacy in reducing symptoms. Going forward, we will formally test whether: (1) the MBSR (BC) program results in greater initial (6 week) and short-term sustained (12 week) improvements in psychological symptoms, physical symptoms, quality of life, and biological stress markers compared to Usual Care; (2) patients in the MBSR (BC) program report greater increases in mindfulness and larger reductions in fear of recurrence which, it turn, reduce psychological and physical symptoms and stress-related hormones, as well as improve quality of life; and (3) the efficacy of the MBSR (BC) program is greatest among patients who present with high anxiety, high perceived stress, low optimism, poor quality of life, and specific symptom profiles (i.e. highly distressed patients). PUBLIC HEALTH RELEVANCE: Project Narrative After treatment for breast cancer, survivors often experience debilitating symptoms that occur singly, or more commonly, in clusters. Limited research and treatment regimens have been established to minimize this high degree of morbidity among breast cancer survivors. This study will formally evaluate an intensive meditation- based stress reduction intervention to determine if it is efficacious in improving psychological and physical symptoms, quality of life, and biological stress markers among breast cancer survivors. If this intervention is shown to be efficacious, the possibility exists of extending its use to minimize morbidity for other types of cancers, as well as severe non-cancer health disorders.

描述（由申请人提供）：乳腺癌是女性中最普遍的癌症形式。治疗完成后，乳腺癌幸存者经常出现残留症状，包括疼痛，疲劳，睡眠功能障碍，焦虑，抑郁和对复发的恐惧。可能发生这种广泛的治疗后症状以及可能伴随压力相关的细胞因子反应的范围（簇）。鉴于该受影响的患者人群的大小，对这一研究不足的癌症幸存者的有效干预至关重要。该申请的主要目标是针对RFA PA-07-074的前2项提交，而PA-07-070对于该第三次提交的意见是严格评估乳腺癌幸存者中基于正念的压力减轻（MBSR）乳腺癌（BC）计划的疗效。具体而言，我们旨在确定：（1）MBSR（BC）计划在治疗完成后改善患者的预后；（2）MBSR（BC）计划有效的方式（机制）；（3）如果特定的患者亚组从MBSR（BC）计划中获得最大的好处。为了实现这些目标，我们将对330名患有0阶段，I，II和III乳腺癌的女性进行随机临床试验，这些乳腺癌进行了肿瘤切除术和/或乳腺切除术，并在完成辅助放射和/或化学疗法治疗后的2年内。这个时期对应于正式医疗停止的关键过渡时间，但仍然存在残留症状。患者将以同等的可能性与MBSR（BC）计划或等待列表的常规护理方案一起随机分配，该方案后来提供了MBSR（BC）计划。将在基线，6周和12周进行患者评估，并包括心理症状（抑郁，焦虑，感知压力），身体症状（疼痛，疲劳，睡眠功能障碍），生活质量，生物压力标志物（促炎性细胞因子，细胞免疫粘附分子，脂肪症）和压力型蛋白酶的生物粘附分子和压力（脂肪症）和压力分子的生物压力标志物和脂肪症和压力（脂肪）和应激率（脂肪）和应激率（脂肪）和应激率（脂肪）和应激性，脂肪症和应激率是酸性的，要评估的MBSR（BC）计划是一个临床计划，该计划提供系统的训练，以通过自我调节引起压力来促进压力减轻。我们的小组已将该计划用于乳腺癌幸存者，并显示出其在减轻症状有效性的初步证据。展望未来，我们将正式测试：（1）MBSR（BC）计划是否会导致更大的初始（6周）和短期持续（12周）改善心理症状，身体症状，生活质量和生物压力标志物与通常的护理相比；（2）MBSR（BC）计划中的患者报告说，正念和更大的减少，担心复发，这会减轻心理和身体症状和与压力相关的激素，并提高生活质量；（3）MBSR（BC）计划的疗效在表现高焦虑，高度感知压力，较低乐观，生活质量差和特定症状特征（即高度困扰的患者）的患者中最大。公共卫生相关性：乳腺癌治疗后的项目叙事，幸存者经常会出现衰弱的症状，或者更常见的是在簇中发生的症状。已经建立了有限的研究和治疗方案，以最大程度地减少乳腺癌幸存者中这种高度的发病率。这项研究将正式评估强烈的基于冥想的压力减轻干预措施，以确定它是否有效地改善了乳腺癌幸存者中的心理和身体症状，生活质量以及生物压力标志物。如果显示这种干预措施有效，则存在扩展其用途最大程度地减少其他类型癌症以及严重的非癌症健康疾病的可能性。