Exploring cancer clinical trial participation in the new normal of COVID-19: The patient perspective.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 461-461
Author(s):  
Martha Ann Raymond ◽  
Margaret-Ann Simonetta
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Patient Perspective ◽  
Ethnically Diverse ◽  
Cancer Clinical Trial ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Diverse Communities ◽  
The Impact

461 Background: The impact of coronavirus (COVID-19) has significantly affected cancer patients seeking to enroll in a clinical trial. The pandemic has led to an unprecedented disruption across the cancer research community pausing trial operations. Data from the National Institute of Health and the National Library of Medicine indicates 988 cancer clinical trials were suspended from March – September 1, 2020, with 60% of institutions enrolling patients at a lower rate. Our research underscores the patient perspective of clinical trial participation amid COVID-19. Methods: July – September 2020 Nationwide eight-week online survey and interviews. Research goals: gain a better understanding of barriers and cultural attitudes of ethnically diverse communities regarding trial participation; learn the enhanced safety measures needed for patients to feel comfortable returning to the clinic; better understand the importance of effective patient-clinician communication. Results: 511 patient participants reported the following insights: 86% reported their healthcare team had not discussed trial participation; 99% reported being comfortable with telehealth visits for pre-screening and monitoring; 82% receive care at community-based hospitals. Barriers to enrollment and additional safety considerations include gaps in outreach and education services for ethnically diverse communities; absence of cultural sensitivity and disregard of historical perspective; financial insecurity and travel; and the need for increased COVID-19 testing, enhanced safety protocols and a proven vaccine. Participants identified their ethnicity as 38% Caucasian; 24% Black/African American; 19% Hispanic/Latino; 16% Asian; 2% Native American/Pacific Islander. Conclusions: Clinical trials provide patients access to the newest treatments, and yet only 2%-3% of adult cancer patients enroll in a trial. Common barriers to trial participation have been widely researched, but now amongst the coronavirus pandemic, additional barriers are evident. Based on our research, our call to action is clear: work with key opinion leaders in ethnically diverse populations to help build trust and mutual respect when discussing research studies; and engage patients and clinicians to openly discuss clinical trial enrollment working toward patient-centered communication. The coronavirus pandemic is a devastating public health threat, and it will take a collective effort from the entire cancer community to minimize the effect of COVID-19 on cancer clinical trial participation.

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.

Impact of clinical trial enrollment on episode costs in the Oncology Care Model (OCM).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6513-6513
Author(s):  
Garrett Young ◽  
Larry Edward Bilbrey ◽  
Edward Arrowsmith ◽  
L. Johnetta Blakely ◽  
Davey B. Daniel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Routine Care ◽  
Cost Of Care ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Total Cost ◽  
Comparator Group ◽  
Hospice Use ◽  
The Impact

6513 Background: Clinical trials are critical for improving outcomes for patients with cancer. However, there is some concern from health insurers that clinical trial participation can increase total cost of care for cancer patients. We investigated the impact of clinical trial participation on total costs paid by Medicare during the OCM program in a large community-based practice. Methods: Tennessee Oncology (TO) is a community oncology practice comprising over 90 oncologists across 30 sites of care. We linked TO trial data and electronic medical record data with OCM data for episodes of care from 2016-2018. To assess the impact of trial participation on total cost relative to routine care, we created matched comparator groups for each OCM episode based on cancer type, metastatic status, number of comorbidities, performance status, and age. Patients with breast cancer receiving hormone therapy only were excluded. Absolute and percent cost differences between groups were calculated for episodes that had a comparator group size of five or greater. Differences in total cost for trial episodes were compared to non-trial episodes, and significance was assessed using the Mann–Whitney U test. We also studied the impact of trial participation on receipt of active treatment in the last 14 days of life (TxEOL), hospice use, and hospitalizations. Results: During the study period, 8,026 completed OCM episodes met study criteria. Patients were enrolled in a clinical trial for 459 of these episodes. On average, episodes during which patients were on trial cost $5,973 less than matched non-trial episodes (Table), independent of early versus late-phase trial. Most savings resulted from decreased drug costs. There were no differences in rates of TxEOL (15% vs. 14% p=1.0), rates of hospitalizations (31% vs. 30% p=0.54), or hospice use (52% vs. 62% p=0.08) between trial and non-trial episodes. Median difference from comparator group average cost was significantly lower for clinical trial episodes (-18% vs. -6%, p<0.01). Conclusions: In the community setting, total costs paid by Medicare for patients participating in clinical trials during OCM episodes were lower than costs for similar patients receiving routine care. Clinical trial participation did not adversely impact end-of-life care or likelihood of hospitalization. These findings suggest that patient participation in clinical trials does not increase total cost of care nor enhance financial risk to payers.[Table: see text]

scholarly journals Are cancer patients better off if they participate in clinical trials? A mixed methods study

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Zandra Engelbak Nielsen ◽  
Stefan Eriksson ◽  
Laurine Bente Schram Harsløf ◽  
Suzanne Petri ◽  
Gert Helgesson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Mixed Methods ◽  
Literature Review ◽  
Cancer Patients ◽  
Standard Care ◽  
Rapid Development ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Positive Effects

Abstract Background Research and cancer care are closely intertwined; however, it is not clear whether physicians and nurses believe that clinical trials offer the best treatment for patients and, if so, whether this belief is justified. The aim of this study was therefore: (i) to explore how physicians and nurses perceive the benefits of clinical trial participation compared with standard care and (ii) whether it is justified to claim that clinical trial participation improves outcomes for cancer patients. Methods A mixed methods approach was used employing semi-structured interviews with 57 physicians and nurses in oncology and haematology and a literature review of the evidence for trial superiority, i.e. the idea that receiving treatment in a clinical trial leads to a better outcome compared with standard care. Inductive thematic analysis was used to examine the interview data. A literature review comprising nine articles was conducted according to a conceptual framework developed by Peppercorn et al. and evaluated recent evidence on trial superiority. Results Our findings show that many physicians and nurses make claims supporting trial superiority, however very little evidence is available in the literature comparing outcomes for trial participants and non-participants that supports their assertions. Conclusions Despite the recent rapid development and use of targeted therapy and immunotherapy, we find no support for trial participation to provide better outcomes for cancer patients than standard care. Hence, our present results are in line with previous results from Peppercorn et al. A weaker version of the superiority claim is that even if a trial does not bring about a direct positive effect, it brings about indirect positive effects. However, as the value of such indirect effects is dependent on the individual’s specific circumstances and preferences, their existence cannot establish the general claim that treatment in trials is superior. Belief in trial superiority is therefore unfounded. Hence, if such beliefs are communicated to patients in a trial recruitment context, it would provide misleading information. Instead emphasis should be on patients volunteering to give an altruistic contribution to the furthering of knowledge and to the potential benefit of future patients.

scholarly journals Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program

2016 ◽  
Vol 21 (4) ◽  
pp. 467-474 ◽  
Author(s):  
Ryan D. Nipp ◽  
Hang Lee ◽  
Elizabeth Powell ◽  
Nicole E. Birrer ◽  
Emily Poles ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cancer Care ◽  
Financial Burden ◽  
Cancer Clinical Trial ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
The Impact ◽  
Financial Burden Of Cancer

Barriers to Clinical Trial Participation as Perceived by Oncologists and Patients

2007 ◽  
Vol 5 (8) ◽  
pp. 753-762 ◽  
Author(s):  
Neal J. Meropol ◽  
Joanne S. Buzaglo ◽  
Jennifer Millard ◽  
Nevena Damjanov ◽  
Suzanne M. Miller ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Treatment Strategies ◽  
Background Information ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Clinical Trial Research ◽  
Psychosocial Barriers ◽  
Medical Oncologists

Although clinical trial research is required for the development of improved treatment strategies, very few cancer patients participate in these studies. The purpose of this study was to describe psychosocial barriers to clinical trial participation among oncologists and their cancer patients. A survey was distributed to all medical oncologists in Pennsylvania and a subset of their patients. Relevant background information and assessment of practical and psychosocial barriers to clinical trial participation were assessed. Among 137 oncologists and 170 patients who completed the surveys, 84% of patients were aware of clinical trials, and oncologists and patients generally agreed that clinical trials are important to improving cancer treatment. However, oncologists and patients were more likely to consider clinical trials in advanced or refractory disease. When considering 7 potential barriers to clinical trials, random assignment and fear of receiving a placebo were ranked highly by both patients and oncologists. Patients identified fear of side effects as the greatest barrier to clinical trial participation, whereas oncologists ranked this psychosocial barrier as least important to their patients. Overall, the study found that although oncologists and patients are aware of clinical trials and have favorable attitudes toward them, psychosocial barriers exist for patients that may impact participation in clinical trials. Furthermore, important discrepancies exist between the perceptions of oncologists and those of patients regarding what the psychosocial barriers are. We concluded that characterizing oncologist and patient perceived barriers can help improve communication and decision making about clinical trials, such that participation may be optimized.

scholarly journals “When Offered to Participate”: A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials

2020 ◽  
Author(s):  
Joseph M Unger ◽  
Dawn L Hershman ◽  
Cathee Till ◽  
Lori M Minasian ◽  
Raymond U Osarogiagbon ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Meta Analysis ◽  
Cancer Control ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Black Patients

Abstract Background Patient participation in clinical trials is vital for knowledge advancement and outcomes improvement. Few adult cancer patients participate in trials. Although patient   decision-making about trial participation has been frequently examined, the participation rate for patients actually offered a trial is unknown. Methods A systematic review and meta-analysis using 3 major search engines was undertaken. We identified studies from January 1, 2000, to January 1, 2020, that examined clinical trial participation in the United States. Studies must have specified the numbers of patients offered a trial and the number enrolled. A random effects model of proportions was used. All statistical tests were 2-sided. Results We identified 35 studies (30 about treatment trials and 5 about cancer control trials) among which 9759 patients were offered trial participation. Overall, 55.0% (95% confidence interval [CI] = 49.4% to 60.5%) of patients agreed to enroll. Participation rates did not differ between treatment (55.0%, 95% CI = 48.9% to 60.9%) and cancer control trials (55.3%, 95% CI = 38.9% to 71.1%; P = .98). Black patients participated at similar rates (58.4%, 95% CI = 46.8% to 69.7%) compared with White patients (55.1%, 95% CI = 44.3% to 65.6%; P = .88). The main reasons for nonparticipation were treatment choice or lack of interest. Conclusions More than half of all cancer patients offered a clinical trial do participate. These findings upend several conventional beliefs about cancer clinical trial participation, including that Black patients are less likely to agree to participate and that patient decision-making is the primary barrier to participation. Policies and interventions to improve clinical trial participation should focus more on modifiable systemic structural and clinical barriers, such as improving access to available trials and broadening eligibility criteria.

Improved clinical trial accrual using a communication tool: Best case/worst case—Clinical trials.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 26-26 ◽  
Author(s):  
Toby Christopher Campbell
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Chart Review ◽  
Treatment Options ◽  
Advanced Lung Cancer ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Worst Case

26 Background: Clinical trials are crucial to the development of new treatments that may improve survival and quality of life for patients. Cancer clinical trials are hampered by chronically low participation rates. A decision support intervention designed to facilitate a shared decision making discussion with cancer patients regarding chemotherapy options could help oncologists align patient preferences with treatment options, including clinical trials. We performed a retrospective chart review comparing lung cancer patients seen in our integrated onco-palliative care clinic (PC) with standard oncology care (SOC) patients for clinical trial participation as a means of assessing potential effectiveness of the tool. The PC clinic is staffed exclusively by the author who also developed the tool. The tool is a combination of a structured discussion paired with a paper diagram the patient takes home which details all the treatment options including best supportive care alone, standard chemotherapy, and a clinical trial. Methods: Charts of every patient seen in our institution with advanced lung cancer from July 2007-June 2011 were reviewed. Eligible patients were those who received any care at our center thus excluding patient seen only for a second opinion. Demographic, treatment details, survival, and hospice utilization data were obtained. There were five oncologists included the SOC group though the vast majority of patients were seen by two providers. All providers (PC and SOC) are academic physicians who work closely together, meet weekly, have clinic on the same day, share the same research staff and have the same promotion requirements. Results: 207 patients with advanced lung cancer were identified, 82 in the PC group. A significantly higher proportion of patients participated in therapeutic clinical trials in the PC group when compared to the SOC group (29% versus 19%, adjusted OR = 2.54, p = 0.014). No difference in overall chemotherapy utilization was seen between the groups. Conclusions: Our chart review provides initial evidence that the best case/worst case: clinical trials tool may help facilitate clinical trial participation in patients with advanced lung cancer who are exploring their options.

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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