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.

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.

Clinical Trials: Are They a Good Buy?

2001 ◽  
Vol 19 (23) ◽  
pp. 4330-4339 ◽  
Author(s):  
Charles L. Bennett ◽  
Jared R. Adams ◽  
Kirstin S. Knox ◽  
Andrew M. Kelahan ◽  
Samuel M. Silver ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase Ii ◽  
Standard Care ◽  
Current Status ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Pilot Studies ◽  
Policy Initiatives ◽  
American Society

PURPOSE: Concern that clinical trials may be too costly has been used to justify traditionally restrictive insurer policies regarding clinical trials. Additionally, fear of insurer reimbursement denial can be a significant barrier to clinical trial participation. In this study, we reviewed the empirical data on costs of clinical trials versus standard care and summarized the current status of policy initiatives related to clinical trial insurance reimbursement. METHODS: Electronic and print data sources were searched for studies on the costs of oncology clinical trials. Information on policy initiatives for clinical trial reimbursement was obtained from the American Society of Clinical Oncology, the American Society of Hematology, and the Coalition of National Cancer Cooperative Groups and from searches of World Wide Web sites. RESULTS: Five pilot studies provided information for 377 patients on phase II/III clinical trials matched with controls on standard care. Cost estimates ranged from 10% lower to 23% higher costs/charges for clinical trials in comparison to standard medical care. Medicare, 14 states, and several private insurers now cover the costs of patient care in “qualifying” clinical trials. CONCLUSION: Findings from small pilot studies suggest that phase II and III clinical trials result in at most modest increases in cost over standard treatment costs. Also, an increasing number of policy makers have decided to support clinical trial reimbursement initiatives. It is hoped that economic data from large observational studies will facilitate widespread and permanent decisions that support reimbursement for phase I, II, and III clinical trial participation.

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 “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.

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]

Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials.

1996 ◽  
Vol 14 (3) ◽  
pp. 984-996 ◽  
Author(s):  
N K Aaronson ◽  
E Visser-Pol ◽  
G H Leenhouts ◽  
M J Muller ◽  
A C van der Schot ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Cancer Patients ◽  
Intervention Group ◽  
Nursing Intervention ◽  
Informed Consent Process ◽  
Consent Process ◽  
Trial Participation ◽  
Oncology Nurse

PURPOSE Here we report the results of a randomized study undertaken to test the efficacy of a supplementary, telephone-based nursing intervention in increasing patients' awareness and understanding of the clinical trials in which they are asked to participate. METHODS During a 12-month period, 180 cancer patients who were approached to participate in a phase II or III clinical trial were randomized to undergo either of the following: (1) standard informed consent procedures based on verbal explanations from the treating physician plus written information (controls); or (2) standard informed consent procedures plus a supplementary, telephone-based contact with an oncology nurse (intervention). For purposes of evaluation, face-to-face interviews were conducted with all patients approximately 1 week after the informed consent process had been completed. RESULTS The two groups were comparable with regard to sociodemographic and clinical variables. Both groups had a high level of awareness of the diagnosis and of the nature and objectives of the proposed treatments. The intervention group was significantly (P < .01) better informed about the following: (1) the risks and side effects of treatment; (2) the clinical trial context of the treatment; (3) the objectives of the clinical trial; (4) where relevant, the use of randomization in allocating treatment; (5) the availability of alternative treatments; (6) the voluntary nature of participation; and (7) the right to withdraw from the clinical trial. The intervention did not have any significant effect on patients' anxiety levels or on rates of clinical trial participation. Patients reported high levels of satisfaction with the intervention. CONCLUSION The use of a supplementary, telephone-based nursing intervention is a feasible and effective means to increase cancer patients' awareness and understanding of the salient issues that surround the clinical trials in which they are asked to participate.

scholarly journals Parental perspectives long term after neonatal clinical trial participation: a survey

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Thomas Salaets ◽  
Emilie Lavrysen ◽  
Anne Smits ◽  
Sophie Vanhaesebrouck ◽  
Maissa Rayyan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Participation ◽  
Drug Trials ◽  
Clinical Trial Participation ◽  
Parental Perspectives ◽  
Positive Experiences ◽  
Almost All

Abstract Background Although recruiting newborns is ethically challenging, clinical trials remain essential to improve neonatal care. There is a lack of empirical data on the parental perspectives following participation of their neonate in a clinical trial, especially at long term. The objective of this study is to assess experiences and emotions of parents, long term after trial participation in an interventional drug trial. Methods Parents of former participants of five neonatal interventional drug trials were surveyed at long term (3–13 years ago) after participation. The survey assessed parental contentment with trial participation, perceived influence of the trial on care and health, emotional consequences of participation, and awareness of typical clinical trial characteristics on 6-point Likert scales. Results Complete responses were received from 123 parents (52% of involved families). Twenty percent of parents did not remember participation. Those who remembered participation reported high contentment with overall trial participation (median 5.00), but not with follow-up (median 3.00). Most parents did not perceive any influence of the trial on care (median 2.00) and health (median 2.43). Almost all parents reported satisfaction and pride (median 4.40), while a minority of parents reported anxiety and stress (median 1.44) or guilt (median 1.33) related to trial participation. A relevant minority was unaware of typical trial characteristics (median 4.20; 27% being unaware). Conclusions Overall, parents reported positive experiences and little emotional distress long term after participation. Future efforts to improve the practice of neonatal clinical trials should focus on ensuring effective communication about the concept and characteristics of a clinical trial during consent discussions and on the follow-up after the trial.

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.

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