Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination thru Engagement in Mindfulness Education (REASSURE ME)

通过参与正念教育减少主动监控压力、不确定性和沉思的影响（REASSURE ME）

• 批准号: 9889048
• 负责人: David Victorson
• 金额: $ 47.14万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-12-01 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9889048
• 关键词: Address; Adherence; Adopted; Adoption; American; Anxiety; Attention; Awareness; Behavior Therapy; Biopsy; Cancer Etiology; Cessation of life; Chronic; Client satisfaction; Clinical; Clinical Trials; Cognitive; Control Groups; Couples; Diagnosis; Disease; Disease Management; Disease Progression; Double-Blind Method; Education; Eligibility Determination; Emotional; Enrollment; Face; Feeling; Fright; Geography; Grant; Health Promotion; Informal Social Control; Intervention; Intervention Studies; Lead; Life; Malignant neoplasm of prostate; Measures; Medical; Monitor; Nature; Operative Surgical Procedures; Outcome; Participant; Patient Outcomes Assessments; Patient Self-Report; Patients; Physiological; Pilot Projects; Placebos; Population; Posttraumatic growth; Prevention; Protocols documentation; Psychological Factors; Quality of life; Radiation; Randomized; Regrets; Research Design; Role; Sampling; Schedule; Site; Spouses; Stress; Therapeutic; Therapeutic Intervention; Time; Treatment Side Effects; Uncertainty; Visit; Withdrawal; Work; active method; adherence rate; base; compliance behavior; cost; design; disorder risk; experience; global health; health related quality of life; improved; men; mindfulness; mindfulness-based stress reduction; negative affect; novel; overtreatment; premature; prevent; prostate cancer risk; psychologic; psychosocial; psychosocial adjustment; public health relevance; resilience; response; satisfaction; screening; skills; stress reduction; stressor; three-arm study; treatment group; tumor progression; urologic

 DESCRIPTION (provided by applicant): Active Surveillance (AS) is an increasingly adopted disease management approach for men diagnosed with low risk prostate cancer who meet very specific eligibility criteria. When combined with decisional ambiguity and concern regarding a choice to forgo active treatment to participate in AS, feelings of fear, uncertainty and a loss of control can arise. As a result, within 2-3 years of observation, some 25% of men who are clinically eligible for AS prematurely opt for definitive treatment. These rates can double by 5 years. Our team has conducted one of the only randomized controlled pilot studies of a therapeutic intervention called Mindfulness Based Stress Reduction (MBSR) to establish feasibility and preliminary efficacy of MBSR in assuaging AS-related psychosocial sequelae, such as fear of cancer progression and uncertainty, with men placed on AS and their spouses. OBJECTIVE: Examine the efficacy of MBSR with a larger, more culturally diverse, and geographically generalizable sample of men on AS and their spouses using a time and attention controlled matched condition. PRIMARY AIM: Examine Longitudinal Differences in Important, AS-Related Self- Reported Outcomes of Stress and Quality of Life Between Treatment and Control Groups Over Time. HYPOTHESIS I: MBSR group participants (n=120 men & 120 spouses) will experience significantly lower anxiety, fear of cancer progression, uncertainty intolerance, rumination, decisional regret, and higher treatment satisfaction, posttraumatic growth and global health related quality of life (HRQOL) compared to Health Promotion (n=120 men & 120 spouses). HYPOTHESIS II: Non-disease progression related attrition from AS will be associated with increased anxiety, fear of cancer progression, uncertainty intolerance, rumination, decisional regret, and lower treatment satisfaction, posttraumatic growth and global health related quality of life (HRQOL). HYPOTHESIS III: MBSR participants will display correspondingly higher rates of adherence to AS compared and Health Promotion participants. STUDY DESIGN: We will use a randomized, placebo-controlled, partially double-blinded study design to examine MBSR over 12 months (n=120 men on AS & 120 spouses), compared with a time matched control condition (n=120 men on AS & 120 spouses). Baseline measures will be obtained just prior to randomization to the three study arms (T1), followed by repeated assessments at 2 months (T2), 6 months (T3) and 12 months (T4). RELEVANCE: This work has the potential to offer men and their partners facing the stressors of AS with specialized emotional, cognitive, and physiological self-regulatory skills to cope more effectively and possibly prolong adherence to medically-warranted AS protocols.

 描述（由适用提供）：主动监视（AS）是一种越来越多的疾病管理方法，对于诊断出符合非常具体资格标准的低风险前列腺癌的男性。当结合决策的歧义和对选择忘记积极治疗以参与AS的选择时，可能会出现恐惧，不确定性和失去控制的感觉。结果，在观察的2 - 3年之内，临床上有资格过早选择确定治疗的男性中约有25％。这些费率可以在5年之前翻一番。我们的团队已经进行了一种称为基于正念的压力减轻（MBSR）的治疗干预措施的唯一随机对照试验研究之一，以确立MBSR在缓解与癌症进展的恐惧和不确定的人及其成员的可行性和初步有效性。目的：使用时间和注意力控制的匹配条件，检查MBSR的效率较大，更具文化多样性和地理上可概括的男性和他们的配偶样本。主要目的：随着时间的推移，随着时间的流逝，检查重要的，与此相关的自我报告的压力和生活质量的纵向差异。假设I：MBSR小组参与者（n = 120名男性和120个配偶）将焦虑，对癌症进展的恐惧，不确定性intlerance，反省，决策回归以及较高的治疗满意度，创伤后的增长和全球健康相关的生活质量（HRQOL）（HRQOL）（HRQOL）与健康促进相比（n = 120名男性和120名男子）。假设II：与AS相关的非疾病进展与焦虑，对癌症进展的恐惧，不确定性摄入率，反省，决策回归以及较低的治疗满意度，创伤后生长和全球健康相关生活质量（HRQOL）有关。假设III：MBSR参与者将表现出较高的与AS相比和健康促进参与者的遵守率。研究设计：与时间匹配的对照条件相比，我们将使用一个随机的，安慰剂对照的，部分双盲的研究设计在12个月内检查MBSR（n = 120名男性＆120个配偶）（AS＆120个配偶）。基线度量将在随机分为三个研究臂（T1）之前获得，然后在2个月（T2），6个月（T3）和12个月（T4）进行重复评估。相关性：这项工作有潜力为男人及其伴侣提供面临的压力源，即具有专门的情感，认知和身体自我调节技能，以更有效地应对，并可能延长对医学保证为方案的遵守。