UCSF Osher Center for Integrative Medicine, University of California, San Francisco, UCSF Box 1726, 1545 Divisadero Street, Suite 301, San Francisco, CA, 94143, USA.
College of Physicians and Surgeons, Columbia University Medical Center, 630 W 168th Street, New York, NY, 10032, USA.
J Racial Ethn Health Disparities. 2020 Oct;7(5):996-1002. doi: 10.1007/s40615-020-00724-8. Epub 2020 Feb 20.
Healthy lifestyle behaviors are an essential component of prostate cancer survivorship; however, it is unknown whether Black participants are adequately represented in randomized controlled trials (RCTs) on lifestyle interventions. The goal of this study was to identify types of lifestyle RCTs that may require improved recruitment resources to enhance generalizability of lifestyle recommendations to Black patients.
ClinicalTrials.gov was used to identify lifestyle RCTs among patients with prostate cancer. Using racial distribution data from the Surveillance, Epidemiology, and End Results (SEER) program as a reference, one-sample proportion tests were performed to assess adequate recruitment of Black participants.
Of 31 lifestyle trials, one trial reported race-specific results. Proportion of Black participants was acquired from 26 trials. Compared to the US population, Black participants were overrepresented in the overall study population (17% versus 15%, p = 0.019). Black participants were underrepresented in trials exploring exercise interventions (9% versus 15%, p = 0.041), trials among patients with advanced disease (9% versus 16%, p < 0.001), and in university-funded trials (12% versus 15%, p = 0.026).
The reporting of race data, and race-specific results when feasible, is essential for clinicians to accurately generalize findings from lifestyle trials. Additional resources may be necessary to aid in strategic recruitment of Black participants for trials on exercise interventions, trials among patients with advanced disease, and in university-funded trials.
健康的生活方式行为是前列腺癌生存的重要组成部分；然而，目前尚不清楚在生活方式干预的随机对照试验（RCT）中是否充分纳入了黑人参与者。本研究的目的是确定可能需要改进招募资源的生活方式 RCT 类型，以增强生活方式建议对黑人患者的普遍性。
使用 ClinicalTrials.gov 识别前列腺癌患者的生活方式 RCT。使用监测、流行病学和最终结果（SEER）计划中的种族分布数据作为参考，进行单一样本比例检验，以评估黑人参与者的充分招募情况。
在 31 项生活方式试验中，有一项试验报告了种族特异性结果。从 26 项试验中获得了黑人参与者的比例。与美国人口相比，黑人参与者在总体研究人群中占比过高（17%比 15%，p=0.019）。在探索运动干预的试验中，黑人参与者的代表性不足（9%比 15%，p=0.041），在晚期疾病患者的试验中，以及在大学资助的试验中（9%比 16%，p<0.001），黑人参与者的代表性不足。
报告种族数据，以及在可行的情况下报告种族特异性结果，对于临床医生准确推广生活方式试验的结果至关重要。可能需要额外的资源来帮助针对运动干预试验、晚期疾病患者的试验以及大学资助的试验，战略性地招募黑人参与者。
