scholarly journals A Case-Control Study Examining Disparities in Clinical Trial Participation Among Breast Surgical Oncology Patients

2019 ◽  
Vol 4 (2) ◽  
Author(s):  
Oluwadamilola M Fayanju ◽  
Yi Ren ◽  
Samantha M Thomas ◽  
Rachel A Greenup ◽  
Terry Hyslop ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pacific Islander ◽  
Surgical Oncology ◽  
Trial Participation ◽  
Lower Income ◽  
Clinical Trial Participation ◽  
Oncology Patients ◽  
Asian Pacific Islander ◽  
Asian Pacific ◽  
Over Time

Abstract Background Clinical trial participation among racial and ethnic minorities remains low despite national efforts. We sought to determine how participation in clinical trials by breast surgical oncology patients has changed over time and what characteristics are associated with participation. Methods Women with breast cancer enrolled in National Cancer Institute–sponsored, cooperative-group trials from 2000 to 2012 and who underwent oncologic surgery (n = 17 125) were compared with trial-eligible women in the National Cancer Database diagnosed in 2000–2012 (n = 792 719). Race-specific trial participation was plotted over time by income and reported as a proportion of the combined cohorts. Factors associated with trial participation were estimated using logistic regression; we report odds ratios (ORs) with 95% confidence intervals (CIs). A P value less than  .05 was considered statistically significant for all analyses. All tests were two-sided. Results Participation declined across all groups over time because of a decrease in the scale and number of trials. In 2000–2003, Asian–Pacific Islander (7.17%), Hispanic (3.48%), and white (7.13%) patients from the highest income group had higher participation than their lower-income counterparts (Asian–Pacific Islander: 3.95%; Hispanic: 2.67%; white: 5.96%), but by 2008–2012, only high-income white patients participated more than lower-income whites (0.32% vs 0.25%, all P < .01). Black (OR = 0.80, 95% CI = 0.75 to 0.85) and Hispanic (OR = 0.84, 95% CI = 0.77 to 0.92) patients were less likely to participate than whites, but there were statistically significant interactions between income and race and ethnicity, with high-income black patients being approximately 50% less likely to participate than lower-income blacks (all P < .001). Conclusions Multifaceted interventions addressing the intersectionality of race, ethnicity, and other patient characteristics are needed to address persistent disparities in trial participation among breast surgical oncology patients.

Disparities in clinical trials participation in a vertically integrated care delivery system.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 128-128
Author(s):  
Ahmed Megahed ◽  
Gary L Buchschacher ◽  
Ngoc J. Ho ◽  
Reina Haque ◽  
Robert Michael Cooper
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Healthcare System ◽  
Care Delivery ◽  
Trial Participation ◽  
Cancer Type ◽  
Clinical Trial Participation ◽  
Integrated Healthcare ◽  
Clinical Trial Enrollment ◽  
Asian Pacific

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]

scholarly journals Patient Income Level and Cancer Clinical Trial Participation

2013 ◽  
Vol 31 (5) ◽  
pp. 536-542 ◽  
Author(s):  
Joseph M. Unger ◽  
Dawn L. Hershman ◽  
Kathy S. Albain ◽  
Carol M. Moinpour ◽  
Judith A. Petersen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Universal Access ◽  
Participation Rate ◽  
Treatment Decision ◽  
Trial Participation ◽  
Lower Income ◽  
Clinical Trial Participation ◽  
Clinical Trial Results ◽  
The Impact

Purpose Studies have shown an association between socioeconomic status (SES) and quality of oncology care, but less is known about the impact of patient SES on clinical trial participation. Patients and Methods We assessed clinical trial participation patterns according to important SES (income, education) and demographic factors in a large sample of patients surveyed via an Internet-based treatment decision tool. Logistic regression, conditioning on type of cancer, was used. Attitudes toward clinical trials were assessed using prespecified items about treatment, treatment tolerability, convenience, and cost. Results From 2007 to 2011, 5,499 patients were successfully surveyed. Forty percent discussed clinical trials with their physician, 45% of discussions led to physician offers of clinical trial participation, and 51% of offers led to clinical trial participation. The overall clinical trial participation rate was 9%. In univariate models, older patients (P = .002) and patients with lower income (P = .001) and education (P = .02) were less likely to participate in clinical trials. In a multivariable model, income remained a statistically significant predictor of clinical trial participation (odds ratio, 0.73; 95% CI, 0.57 to 0.94; P = .01). Even in patients age ≥ 65 years, who have universal access to Medicare, lower income predicted lower trial participation. Cost concerns were much more evident among lower-income patients (P < .001). Conclusion Lower-income patients were less likely to participate in clinical trials, even when considering age group. A better understanding of why income is a barrier may help identify ways to make clinical trials better available to all patients and would increase the generalizability of clinical trial results across all income levels.

scholarly journals Adolescents’ and Parents’ Attitudes Toward Adolescent Clinical Trial Participation: Changes Over One Year

2018 ◽  
Vol 13 (4) ◽  
pp. 383-390 ◽  
Author(s):  
Rebecca K. Tsevat ◽  
Carmen Radecki Breitkopf ◽  
Sara E. Landers ◽  
Ariel M. de Roche ◽  
Christine Mauro ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Health Study ◽  
Trial Participation ◽  
Willingness To Participate ◽  
Clinical Trial Participation ◽  
Framework Analysis ◽  
New Knowledge ◽  
One Year ◽  
Qualitative Responses ◽  
Over Time

Little is known about how adolescents’ and parents’ thoughts about participation in clinical trials change over time. In this study, adolescent (14-17 years)–parent dyads were asked about willingness to participate in a hypothetical reproductive health study. A year later, they were asked how their thoughts about the study had changed. Qualitative responses were coded and analyzed using framework analysis. Thirty-two percent of adolescents and 18% of parents reported changes in thoughts; reasons included general changes in perception, clearer understanding, new knowledge or experiences, increased maturity/age of adolescents, and changes in participants independent of the study. Adolescents and parents may benefit from learning about studies multiple times, and investigators should account for development and new experiences to optimize adolescent research enrollment.

Breast cancer patients' willingness to travel to participate in a clinical trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14031-e14031 ◽  
Author(s):  
Nicholas Zdenkowski ◽  
James F. Lynam ◽  
Laura Wall ◽  
Scott Brown ◽  
Kathryn Wells ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Travel Time ◽  
Past History ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Oncology Patients ◽  
Early Stage Disease ◽  
National Breast

e14031 Background: The option of clinical trial participation is an important component of high quality care for oncology patients. Despite a recognised need for generalizable research results to guide future practice, and the desire of current oncology patients to participate in trials, only 2-5% of oncology patients in developed nations enroll in a clinical trial. We aimed to determine the willingness of patients to travel, change location and/or clinician to participate in a clinical trial. Methods: Members of a national breast cancer consumer organization were invited by email to respond to an online cross-sectional survey. Questions included demographics, remoteness of residence, prior involvement in clinical trials and location of usual care. This was followed by a Discrete Choice Experiment (DCE) comprising an introduction and 10 hypothetical scenarios to test the effect of variation in travel time, clinician, treating centre, travel cost and type of trial. Results: Between July and August 2016, 288 responses were received, mean age 58. 86% had early stage disease, 51% were currently receiving treatment, 21% had prior clinical trial involvement. Ninety percent were willing to participate in a clinical trial in at least one scenario. Factors that decreased the likelihood of interest in clinical trial participation were increasing travel time, change in oncologist and out of pocket expenses. Type of trial (randomised placebo controlled; randomised open label; single arm) did not influence the decision. If the oncologist remained the same and there were no costs, respondents were willing to travel a mean extra 127 minutes, however if the oncologist changed and there were additional costs, they were willing to travel a mean of 30 minutes. If the oncologist changed and there was no cost, they were willing to travel a mean of 82 minutes. Conclusions: This group of respondents with a past history of breast cancer expressed interest in clinical trial participation, however willingness to travel in the most likely scenario (change oncologist and pay no additional cost) was 82 minutes. To facilitate optimal access to clinical trials, clinicians should consider referral within and between institutions.

Changes in clinical trial participation among adolescent and young adult (AYA) cancer patients from 2006 to 2013 in the United States.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18037-e18037 ◽  
Author(s):  
Theresa Keegan ◽  
Dolly Penn ◽  
Qian Li ◽  
Brad Pollock ◽  
Marcio H. Malogolowkin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Hodgkin Lymphoma ◽  
The United States ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Racial Ethnic ◽  
Over Time

e18037 Background: Stagnant outcomes for AYAs (15 to 39 years) with cancer are partly attributed to poor enrollment onto clinical trials. Initiatives have focused on increasing accrual, but changes at the population-level are unknown. We examined patterns of clinical trial participation over time in AYA cancer patients. Methods: We utilized medical record data from AYAs in two National Cancer Institute Patterns of Care Studies identified through the Surveillance, Epidemiology and End Results (SEER) Program. Among 1,358 AYAs diagnosed with non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL), acute lymphoblastic leukemia (ALL), germ cell cancer, and sarcoma in 2006 and 3,560 AYAs diagnosed with NHL, HL, ALL, sarcoma, and breast cancer in 2012/2013, we used unconditional logistic regression to evaluate patient and provider characteristics associated with enrollment by year of diagnosis. Analyses were weighted to reflect the SEER populations and associations are summarized as adjusted odds ratios (OR) with 95% confidence intervals (CI). Results: From 2006 to 2012/2013, clinical trial participation increased from 14.8% to 17.9% among AYAs diagnosed with NHL, HL, ALL and sarcoma (p < 0.0001), primarily due to increased participation among ALL patients (2006: 37.4%; 2012/2013: 42.3%). In 2012/2013, participation varied by type of cancer, with the highest among those with ALL and sarcoma (31.2%), followed by HL (9.4%), NHL (6.9%) and breast cancer (4.3%). In both study years, multivariate analyses demonstrated that younger patients and those treated by pediatric oncologists (OR = 3.5; CI: 2.6-4.7) were more likely to enroll onto clinical trials. Uninsured AYAs were less likely to enroll in 2006 but no association was observed in 2012/2013. Hispanic (OR = 0.5; CI: 0.4-0.6), Black (OR = 0.6; CI: 0.5-0.9) and Asian (OR = 0.4; CI: 0.3-0.6) AYAs were less likely to enroll in 2012/2013 but not 2006. Conclusions: Our study identified increasing overall clinical trial participation over time. Disparities in likelihood of participating for racial/ethnic minority groups increased suggesting the need to improve access to clinical trials for all racial/ethnic groups to improve care and outcomes.

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