Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.
Department of Psychology, University of Miami, Coral Gables, FL, United States.
Contemp Clin Trials. 2018 Aug;71:173-180. doi: 10.1016/j.cct.2018.06.010. Epub 2018 Jul 9.
Almost 2.8 million men in the U.S. are living with prostate cancer (PC), accounting for 40% of all male cancer survivors. Men diagnosed with prostate cancer may experience chronic and debilitating treatment side effects, including sexual and urinary dysfunction, pain and fatigue. Side effects can be stressful and can also lead to poor psychosocial functioning. Prior trials reveal that group-based cognitive behavioral stress and self-management (CBSM) is effective in reducing stress and mitigating some of these symptoms, yet little is known about the effects of culturally-translated CBSM among Spanish-speaking men with PC. This manuscript describes the rationale and study design of a multi-site, randomized controlled trial to determine whether participation in a culturally adapted cognitive behavioral stress management (C-CBSM) intervention leads to significantly greater reductions in symptom burden and improvements in health-related quality of life relative to participation in a non-culturally adapted cognitive behavioral stress management (CBSM) intervention. Participants (N = 260) will be Spanish-speaking Hispanic/Latino men randomized to the standard, non-culturally adapted CBSM intervention (e.g., cognitive behavioral strategies, stress management, and health maintenance) or the culturally adapted C-CBSM intervention (e.g., content adapted to be compatible with Hispanic/Latino cultural patterns and belief systems, meanings, values and social context) for 10 weeks. Primary outcomes (i.e., disease-specific symptom burden and health-related quality of life) will be assessed across time. We hypothesize that a culturally adapted C-CBSM intervention will be more efficacious in reducing symptom burden and improving health-related quality of life among Hispanic/Latino men when compared to a non-culturally adapted CBSM intervention.
美国约有 280 万男性患有前列腺癌（PC），占所有男性癌症幸存者的 40%。被诊断患有前列腺癌的男性可能会经历慢性和衰弱性的治疗副作用，包括性功能和尿功能障碍、疼痛和疲劳。副作用可能会带来压力，也会导致较差的社会心理功能。先前的试验表明，基于小组的认知行为应激和自我管理（CBSM）在减轻压力和缓解其中一些症状方面是有效的，但对于西班牙语前列腺癌患者的文化翻译 CBSM 的影响知之甚少。本手稿描述了一项多地点、随机对照试验的基本原理和研究设计，以确定参与文化适应的认知行为应激管理（C-CBSM）干预是否会导致症状负担显著减轻，以及健康相关生活质量显著改善，而不是参与非文化适应的认知行为应激管理（CBSM）干预。参与者（N=260）将被随机分为标准、非文化适应的 CBSM 干预组（例如，认知行为策略、应激管理和健康维护）或文化适应的 C-CBSM 干预组（例如，内容适应与西班牙裔/拉丁裔文化模式和信仰系统、意义、价值观和社会背景兼容），为期 10 周。主要结果（即特定疾病的症状负担和健康相关生活质量）将随时间进行评估。我们假设，与非文化适应的 CBSM 干预相比，文化适应的 C-CBSM 干预在减轻西班牙裔/拉丁裔男性的症状负担和改善健康相关生活质量方面将更有效。
