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

 描述(由申请人提供)：主动监测(AS)是一种越来越多地采用的疾病管理方法，适用于符合非常特定的资格标准的被诊断为低风险前列腺癌的男性。当再加上对放弃积极治疗以参与AS的选择的模棱两可和担忧时，可能会产生恐惧、不确定和失去控制的感觉。因此，在观察的2-3年内，临床上有资格过早接受AS的男性中，约有25%选择了明确的治疗。这些利率可能会在5年内翻一番。我们的团队进行了一项名为基于正念的压力减轻(MBSR)治疗干预的仅有的随机对照初步研究之一，以确定MBSR在缓解AS相关心理社会后遗症方面的可行性和初步疗效，如对癌症进展和不确定性的恐惧，男性接受AS及其配偶治疗。目的：使用时间和注意力控制的配对条件，以更大的、更具文化多样性和地域可概括性的男性样本来检验MBSR对AS及其配偶的有效性。主要目的：研究随着时间的推移，治疗组和对照组之间在重要的、AS相关的自我报告的压力和生活质量结果方面的纵向差异。假设一：与健康促进组(n=120名男性和120名配偶)相比，MBSR组参与者(n=120名男性和120名配偶)将经历显著更低的焦虑、对癌症进展的恐惧、不确定、不容忍、沉思、决定后悔，以及更高的治疗满意度、创伤后成长和与全球健康相关的生活质量(HRQOL)。假设II：AS的非疾病进展相关的自然减退将与增加的焦虑、对癌症进展的恐惧、不确定、不耐受、沉思、决定后悔、较低的治疗满意度、创伤后成长和全球健康相关生活质量(HRQOL)相关。假设III：与健康促进参与者相比，MBSR参与者将表现出相应更高的依从率。研究设计：我们将使用随机、安慰剂对照、部分双盲的研究设计来检查12个月的MBSR(n=120名男性AS和120名配偶)，与时间匹配的对照条件(n=120名AS和120配偶)进行比较。基线测量将在随机分配到三个研究小组(T1)之前获得，然后在2个月(T2)、6个月(T3)和12个月(T4)重复评估。相关性：这项工作有可能为面临AS应激源的男性和他们的伴侣提供专门的情感、认知和生理自我调节技能，以更有效地应对，并可能延长对医学上保证的协议的遵守。

 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.