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（由申请人提供）：主动监测（AS）是一种越来越多地被诊断为低风险前列腺癌的男性采用的疾病管理方法，符合非常具体的资格标准。当与决策模糊和对选择放弃积极治疗参与AS的关注相结合时，可能会出现恐惧，不确定性和失控的感觉。因此，在2-3年的观察期内，约25%的临床符合AS条件的男性过早选择了明确的治疗。5年后，这些比率可能会翻一番。我们的团队进行了一项名为正念减压（MBSR）的治疗干预的随机对照试点研究，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，例如对癌症进展和不确定性的恐惧，男性及其配偶。目的：在时间和注意力控制的匹配条件下，用更大的、更具文化多样性的、地理上可推广的AS男性及其配偶样本来检查正念减压疗法的疗效。主要目标：检查治疗组和对照组之间随时间推移的重要AS相关自我报告的压力和生活质量结果的纵向差异。假设一：与健康促进（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）将经历显着降低的焦虑，对癌症进展的恐惧，不确定性不耐受，反刍，决策后悔，以及更高的治疗满意度，创伤后成长和全球健康相关生活质量（HRQOL）。假设二：AS的非疾病进展相关损耗将与焦虑增加、对癌症进展的恐惧、不确定性不耐受、反刍、决策后悔和治疗满意度降低、创伤后成长和总体健康相关生活质量（HRQOL）相关。假设三：正念减压疗法的参与者与健康促进的参与者相比，会表现出更高的坚持率。研究设计：我们将采用随机、安慰剂对照、部分双盲的研究设计来检查12个月内的正念减压（n=120名男性接受AS治疗，120名配偶），并与时间匹配的对照条件（n=120名男性接受AS治疗，120名配偶）进行比较。将在随机分配至三个研究组（T1）之前获得基线测量值，然后在2个月（T2）、6个月（T3）和12个月（T4）时进行重复评估。相关性：这项工作有可能为面临AS压力源的男性及其伴侣提供专业的情感，认知和生理自我调节技能，以更有效地科普并可能延长对医学保证的AS协议的遵守。