London Laricca, Hurtado-de-Mendoza Alejandra, Song Minna, Nagirimadugu Ankita, Luta Gheorghe, Sheppard Vanessa B
Department of Microbiology, Howard University College of Medicine, Washington, DC, USA.
Department of Oncology, Georgetown University Medical Center and Georgetown-Lombardi Comprehensive Cancer Center, Breast Cancer Program, Washington, DC, USA.
Contemp Clin Trials. 2015 Jan;40:74-80. doi: 10.1016/j.cct.2014.11.013. Epub 2014 Nov 26.
Latinas are underrepresented in clinical trials despite the rise in Hispanic population. This study examines the factors associated with Latinas' willingness to participate in preventive breast cancer randomized clinical trials (RCTs).
Women self-identifying as Latina, over age 40, with no prior history of breast cancer were eligible. Using the Behavior Model for Vulnerable Populations, we administered a survey (n=168) to assess predisposing (e.g., knowledge), enabling (e.g., trust) and need factors (e.g., risk perception). Intention to participate was defined using a lenient (maybe, probably or definitely) and a stringent criterion (probably and definitely). Chi-square tests and logistic regression models examined the associations of predisposing, enabling, and need factors with women's intentions to participate in RCTs.
Most participants (74.9%) were monolingual Spanish-speaking immigrants. Most (83.9%) reported willing to participate in clinical trials using the lenient definition (vs. 43.1% under the stringent definition). Using the lenient definition, the odds of willing to participate in RCTs were significantly lower for unmarried women (OR=.25, 95% CI=.08-.79) and those with lower cancer risk perceptions (OR=.20, 95% CI=.06-.63), while being significantly higher for women with lower language acculturation (OR=6.2, 95% CI=1.8-20.9). Using the stringent definition, women who did not endorse a motivation to enroll to help family members (if they had cancer) had significantly lower odds to report intent (OR=.33, 95% CI=.13-.86).
Many RCTs may have limited generalizability due to the low representation of minorities. Culturally targeted interventions that address the importance of family for Latinos may ultimately increase their participation in RCTs.
尽管西班牙裔人口有所增加,但拉丁裔女性在临床试验中的代表性不足。本研究探讨与拉丁裔女性参与预防性乳腺癌随机临床试验(RCT)意愿相关的因素。
年龄超过40岁、无乳腺癌病史且自我认定为拉丁裔的女性符合条件。我们使用弱势群体行为模型进行了一项调查(n = 168),以评估易感性因素(如知识)、促成因素(如信任)和需求因素(如风险感知)。参与意愿通过宽松标准(可能、大概或肯定)和严格标准(大概和肯定)来定义。卡方检验和逻辑回归模型检验了易感性、促成性和需求因素与女性参与RCT意愿之间的关联。
大多数参与者(74.9%)是只说西班牙语的移民。大多数(83.9%)报告愿意根据宽松定义参与临床试验(相比之下,根据严格定义为43.1%)。根据宽松定义,未婚女性(OR = 0.25,95% CI = 0.08 - 0.79)和癌症风险感知较低的女性(OR = 0.20,95% CI = 0.06 - 0.63)参与RCT的几率显著较低,而语言文化适应程度较低的女性参与几率显著较高(OR = 6.2,95% CI = 1.8 - 20.9)。根据严格定义,不认可为帮助家庭成员(如果他们患癌症)而参与的动机的女性报告参与意愿的几率显著较低(OR = 0.33,95% CI = 0.13 - 0.86)。
由于少数群体代表性不足,许多RCT的可推广性可能有限。针对文化特点的干预措施,解决家庭对拉丁裔的重要性问题,最终可能会增加他们参与RCT的比例。