Factors Affecting Parental Satisfaction, Anxiety and Comprehension of the Informed Consent in Pediatric Oncology Clinical Trials
Survival in pediatric cancer has improved dramatically, in part due to high patient enrollment in clinical trials. Whereas Hispanic children have higher incidence of certain cancers, they have poorer survival rates than Non-Hispanic Whites (NHW). Although it is projected that by 2050, Hispanics will comprise 29% of the U.S population, they have fewer opportunities to participate in research. Therefore outcomes data are based on information obtained mostly from NHWs. Low participation of minorities in trials has been reported and may result from the complexity and inadequacies of the informed consent (IC) process. We demonstrated that whereas Hispanics comprise 41% of our patient population, they are significantly underrepresented in research. Despite the great need to address cancer disparities in minorities, there is little investigation of the factors influencing IC and accrual for pediatric cancer trials in Hispanics.
The proposed research will provide novel data regarding barriers to research participation in Hispanics. We aim to identify the factors that result in lower participation among Hispanics and other underserved individuals; improve the IC process overall and increase clinical trial participation in minorities; and eventually improve survival equally by increasing recruitment among Hispanics. To our knowledge, this will be the first study with a sample that includes a significant representation of Hispanics and Spanish-speakers; therefore it will fill this knowledge gap. This work will constitute an initial step to design evidence-based interventions to ensure ethical procedures in clinical trial accrual, particularly in Hispanics, the fastest growing ethnic group in the U.S.