Increasing underrepresented minority cancer patient enrollment into cancer clinical trials: A systematic review.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18574-e18574
Author(s):  
Rosa Nouvini ◽  
Patricia A. Parker ◽  
Charlotte Malling ◽  
Kendra Godwin ◽  
Rosario Costas-Muñiz

e18574 Background: Minorities continue to be underrepresented in clinical trials despite the National Institute of Health’s Revitalization Act, passed in 1993, mandating the representation of women and underrepresented minority groups in clinical trials. Studies have shown that although Blacks represent 15% and Hispanics 13% of the cancer population, their clinical trial enrollment rates in are disproportionately low at 4-6% and 3-6% respectively. We conducted a systematic review exploring interventions aimed at improving clinical trial enrollment for racial and ethnic minorities. Methods: A systematic search of PubMed, Cochrane CENTRAL, and Ovid PsycINFO was conducted for English-language studies of humans since 1993. Inclusion criteria included peer-reviewed, U.S.-based studies with interventions aimed to recruit underrepresented minority adult cancer patients into cancer clinical trials. We defined underrepresented minority groups as Black, Hispanic/Latino, Asian, American Indian/Alaska Native and Native Hawaiian/other Pacific Islander. Results: A total of 2471 titles and abstracts were identified and 2324 were excluded based on the eligibility criteria. A full text review was conducted of the remaining 147 articles, of which only 9 met criteria for our review. The interventions included patient navigation/coaching (n = 4), a clinical trial educational video (n = 2), institutional research infrastructure changes (n = 1), a relationship building and social marketing recruitment model (n = 1) and cultural competency training for providers (n = 1). Studies were conducted in a variety of practice settings including national cancer institutes and community practices. The quality of evidence was limited by the heterogeneity of study methods, patient representation and bias. Several studies had a homogeneous population of Black patients. Most studies (n = 7) were single arm trials that compared results to either historical controls or those cited in the existing literature; two studies were randomized controlled trials. A statistically significant improvement in accrual was shown in three of the patient navigation interventions, one of the clinical trial educational videos, the institutional research infrastructure change and the relationship building and social marketing recruitment model. The common threads to many of these successful interventions were support through the cancer care continuum, cultural congruency of research staff and culturally catered clinical trial educational materials. Conclusions: This systematic review illustrates several mechanisms by which to increase cancer clinical trial recruitment for cancer patients of underrepresented minority backgrounds in a variety of clinical settings. Randomized controlled trials with representation of multiple races/ethnicities are needed to further explore the benefits of these interventions.

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi21-vi21
Author(s):  
Ramin Morshed ◽  
Sheantel Reihl ◽  
Sofia Kakaizada ◽  
Eric Zhang ◽  
Jacob Young ◽  
...  

Abstract OBJECT Under-enrollment in clinical trials significantly limits valid analyses of clinical interventions and generalizability of findings. Often it results in premature study termination, with estimates of 22% to 50% of clinical trials terminated due to poor accrual. Currently, there are limited reports addressing the influence of race/ethnicity and socioeconomic status on clinical trial enrollment in patients with adult glioma. The goal of this study was to determine if these factors impact clinical trial participation for glioma patients. METHODS 852 adult patients were identified from the UCSF Tumor Board Registry and analyzed to determine the rate of therapeutic clinical trial consideration, tumor board recommendation, and study enrollment based on clinical reports in their electronic medical records. RESULTS At initial diagnosis, 30.7% and 18.0% of glioma patients were recommended and enrolled in a therapeutic clinical trial, respectively. At recurrence, 38.7% and 25.3% of patients were recommended and enrolled in a clinical trial, respectively. Nineteen percent of the study population belonged to a NIH-designated underrepresented minority group; Asian/Pacific-Islander comprising 10.3% overall. On univariate analysis, only in-state location, distance to the hospital, and WHO grade were associated with consideration, recommendation, and enrollment at initial diagnosis and recurrence. Minority status, insurance type, median household income, and percent below poverty were not associated with clinical trial recommendation or enrollment. CONCLUSION Race and socioeconomic status did not impact clinical trial consideration, tumor board recommendation, or study enrollment. Our results do not support the premise that provider decisions are impacted by biases based on minority or socioeconomic status.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18130-e18130
Author(s):  
Mina S. Sedrak ◽  
Arti Hurria ◽  
Daneng Li ◽  
Kevin George ◽  
Simran Padam ◽  
...  

e18130 Background: Despite the disproportionate impact of cancer on older adults, older patients are vastly underrepresented in clinical trials that set the standards for cancer treatment. To better understand the reasons for this disparity, we conducted a systematic review of studies that have specifically examined barriers and interventions to improve clinical trial enrollment of older adults with cancer. Methods: We conducted a comprehensive two-step search strategy. First, we consulted an information specialist to develop an electronic search for the following databases from inception to January 15, 2019: PubMed, Ovid/Medline, Embase, Scopus, PsycINFO, and Cochrane library. Second, references of retrieved key articles were screened for relevant studies. Two authors then independently reviewed all titles and abstracts (N = 10,985) and examined studies for full text eligibility (N = 221). Inclusion criteria were: 1) original research; 2) study assessed barriers and/or interventions to enrollment in oncology clinical trials; 3) included patients ≥ 60 years with cancer. Narrative reviews and abstracts without full text were excluded. Data was extracted by independent raters and summarized using a qualitative analysis software, NVivo v12. Results: 12 observational studies examining barriers and 1 randomized intervention were included. Barriers were assessed at the patient level (N = 5 studies), healthcare professional (HCP) level (N = 5), and both patient and HCP levels (N = 2). Stringent eligibility criteria (N = 7) and oncologists’ concerns for toxicity (N = 7) were the most common barriers cited. Patient barriers included transportation (N = 6), time/burden (N = 6), and awareness (N = 6). Although caregiver barriers (N = 4) were identified, none of the studies examined caregiver perceptions. One study evaluated a physician-directed educational intervention and found no significant impact on accrual of older adults. Conclusions: Although several studies have examined the barriers to accrual of older adults with cancer, only one intervention study has attempted to address these barriers. Given the aging of the cancer population, new strategies for including older adults in cancer clinical trials are critically needed.


Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.


2021 ◽  
Author(s):  
Omid Asbaghi ◽  
Vihan Moodi ◽  
Amir Hadi ◽  
Elham Eslampour ◽  
Mina Shirinbakhshmasoleh ◽  
...  

A number of clinical trials have examined the effect of almond intake on the lipid profile in recent years; however, the results remain equivocal.


Author(s):  
Zeinab Yazdanpanah ◽  
Mandana Amiri ◽  
Azadeh Nadjarzadeh ◽  
Hadis Hooshmandi ◽  
Maryam Azadi-Yazdi

Introduction: Hypertension is a chronic condition that might lead to renal and cardiovascular diseases. The previous trials examining the effect of cinnamon supplementation on blood pressure have led to conflicting results. The present systematic review aimed to summarize the effect of cinnamon supplementation on blood pressure using a meta-analysis of published randomized controlled clinical trials. Methods: To identify the eligible articles, MEDLINE, SCOPUS, ISI Web of Science, and Google Scholar were searched from inception until September 2019 for relevant articles. The risk of bias assessment was performed using the Cochrane collaboration tool. A Random-effects model was applied to calculate the summary effects. Results: Totally, 11 trials with 686 participants were included in this systematic review and meta-analysis. The dose of cinnamon supplement consumption varied from 500 to 10000 mg/d. The meta-analysis revealed that cinnamon supplementation significantly decreases systolic blood pressure (SBP) [WMD (weighted mean difference)= -5.72 mmHg, 95% confidence interval (CI): -8.63 to -2.80; P<0.001, I2= 81.1)] and diastolic blood pressure (DBP) (WMD= -4.06 mmHg, 95% CI: -6.68 to -1.44; P= 0.002, I2 = 88.6). Subgroup analysis suggested no significant reduction of DBP in subjects with diabetes (WMD= -2.015 mmHg, 95% CI: -4.55 to 0.52; P= 0.12, I2 = 72.3) and prediabetes or metabolic syndrome (WMD= -4.8 mmHg, 95% CI: -10.06 to 0.44; P= 0.073, I2= 92.5). Conclusions: Cinnamon supplementation could be beneficial in lowering SBP and DBP in adults. Further studies with different doses are recommended to confirm the present findings.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 128-128
Author(s):  
Ahmed Megahed ◽  
Gary L Buchschacher ◽  
Ngoc J. Ho ◽  
Reina Haque ◽  
Robert Michael Cooper

128 Background: Sparse data exists on the diversity clinical trial enrollment in community settings. This information is important to ensure equity of care and generalizability of results. Methods: We conducted a retrospective cohort study of members of an integrated healthcare system diagnosed with invasive malignancies (excluding non-melanoma skin cancers) between 2013-2017 to examine demographics of the oncology population compared to those who enrolled in a clinical trial. Logistic regression was used to assess correlates of clinical trial participation, comparing general and screened samples to enrolled sample. Odds ratios were adjusted for gender, geocoded median household income, cancer type, and stage. Results: Of the 84,977 patients with a cancer diagnosis, N = 2606 were screened for clinical trial participation and consented, and of those N = 1372 enrolled. The percent of Latinx (25.8% vs 24.0%; OR 0.9? CI 0.72-1.05) and African American/Black (10.9% vs 11.1%; OR 0.92 CI 0.75-1.11) clinical trial participation mirrored that of the general oncology population, respectively using Non-Hispanic Whites as reference. Asian/Pacific Islander had equal odds of clinical trial enrollment (OR 1.08 CI 0.92-1.27). The enrolled population was younger than the general oncology population. Conclusions: This study suggests that in an integrated healthcare system with equal access to care, the clinical trials population is well representative of its general oncology population.[Table: see text]


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