Clinical trials navigator: Patient-centered access to clinical trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14024-e14024
Author(s):  
Caroline M. Hamm ◽  
Krista Naccarato ◽  
Stephen Sundquist ◽  
Suzana Kovacevic ◽  
Youshaa El-Abed ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Trial Design ◽  
Stage Iv ◽  
Trial Participation ◽  
Patient Centered ◽  
Number Of Patients ◽  
Significant Interest ◽  
Status Information ◽  
Turn Around Time

e14024 Background: Despite recommendations from premier institutions such as NCCN that all cancer patients should be entered on clinical trials, only 3 – 5 % of adult cancer patients are enrolled on clinical trials in North America. The reason for this is multi-factorial and includes poor trial design, inappropriate endpoints, inappropriate inclusion/exclusion factors, attitudes about trial participation held by patient and/or treating physician and lack of trial availability. Methods: To address issues of trial availability, in March 2019, we initiated a novel service to help Canadian patients find clinical trial options. The service compares patient demographic and health status information provided against potential opportunities sourced using clinicaltrials.gov and Canadian clinical trials websites. A report presenting outcomes of CTN review is developed for the requesting patient or physician. An interview is provided for the self-referring patient by supporting physicians. Results: To date 96 patients have used this service. Most (94%) were stage IV or refractory/ relapsed. Smaller disease sites represented 23% of our patient population (brain, sarcoma, pancreas). Our turn-around-time from request of services to delivery of report to patient or physician improved over time and is currently 24 hours during the working week. Of those eligible, 25% of patients died before referral, the median time from referral to the CTN to the patient’s death was 109 days (3 – 188 days). Conclusions: Significant interest from both physicians and patients for this service was identified. Strategies are being developed to encourage earlier referrals to clinical trials would improve number of patients entering clinical trials as 25% of our patients. [Table: see text]

Improving the inclusion rate in clinical trials of bladder cancer despite COVID-19 pandemic by using ASCO quality training program.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18674-e18674
Author(s):  
Natalia Vidal ◽  
Juan Gomez ◽  
Isabel Galante ◽  
Jose Luis Senovilla ◽  
Jose-Luis Gonzalez-Larriba ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Training Program ◽  
Cancer Patients ◽  
Stage Iv ◽  
Invasive Disease ◽  
Enrollment Rate ◽  
Number Of Patients ◽  
Inclusion Rate ◽  
First Time

e18674 Background: In 2019, we used the American Society of Clinical Oncology (ASCO) Quality Training Program (QTP) as an instrument to improve the inclusion rate in clinical trials (CTs) for bladder cancer patients from 24% in 2018 to 43,75% in 2019. CTs play an important role in developing new treatments, expanding or refining treatments that are already available, and/or identifying behavioral changes that can prolong or improve the lives of subjects. Therefore, we believe it is important for patients and for society to maintain the inclusion rate in clinical trials despite COVID-19 pandemic. Methods: We collected the number of bladder cancer patients evaluated for the first time in the Oncology department, the number of patients who were offered a clinical trial, the screen failures and the number of patients enrolled in CTs. Results: In 2019, we were able to increase the enrollment rate in CTs for bladder cancer patients to from 24% to 43,75% thanks to the ASCO-QTP. With this program we created a list of measures and identified the ones that would have a greater impact. The one that seems to have had the highest impact is the diffusion of CTs in the Investigation Unit and the Genitourinary (GU) board. In 2020, thanks to this measure and despite the COVID-19 pandemic, we were able to maintain a 40,81% enrollment rate. When analyzing the patients evaluated for the first time in the Oncology department, 48 in 2019 and 49 in 2020, there were some interesting differences. In 2020, 42,86% had stage IV disease with respect to 39,6% in 2019, and only 22,44% had non-muscle invasive disease (NMIBC) versus 33,33% in 2019. However, thanks to the diffusion of CTs in the Investigation Unit and in the GU-board, which translates in an early derivation of patients to Medical Oncology and an increase in the number of available CTs, we were able to offer a CT to 73,5% of patients in 2020 against 60,4% in 2019. Although there was an increase of screen failures in 2020 (32,65% vs. 16,66%), 50% of them were due to the absence of a biomarker in a biomarker driven CT, with respect to 25% in 2019. Conclusions: Using ASCO-QTP as an instrument, we identified the importance of the diffusion of CTs and the close collaboration between departments. Maintaining these measures, we were able to uphold the inclusion rate in CTs for bladder cancer patients in 40,81% despite the later diagnosis of patients due to COVID-19 pandemic.

A novel, hybrid, single- and multi-site clinical trial design for CLN3 disease, an ultra-rare lysosomal storage disorder

2019 ◽  
Vol 16 (5) ◽  
pp. 555-560 ◽  
Author(s):  
Heather R Adams ◽  
Sara Defendorf ◽  
Amy Vierhile ◽  
Jonathan W Mink ◽  
Frederick J Marshall ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Rare Diseases ◽  
Trial Design ◽  
Neurodegenerative Disorder ◽  
Clinical Trial Design ◽  
Trial Participation ◽  
Local Participation ◽  
Cln3 Disease ◽  
Study Participants

Background Travel burden often substantially limits the ability of individuals to participate in clinical trials. Wide geographic dispersion of individuals with rare diseases poses an additional key challenge in the conduct of clinical trials for rare diseases. Novel technologies and methods can improve access to research by connecting participants in their homes and local communities to a distant research site. For clinical trials, however, understanding of factors important for transition from traditional multi-center trial models to local participation models is limited. We sought to test a novel, hybrid, single- and multi-site clinical trial design in the context of a trial for Juvenile Neuronal Ceroid Lipofuscinosis (CLN3 disease), a very rare pediatric neurodegenerative disorder. Methods We created a “hub and spoke” model for implementing a 22-week crossover clinical trial of mycophenolate compared with placebo, with two 8-week study arms. A single central site, the “hub,” conducted screening, consent, drug dispensing, and tolerability and efficacy assessments. Each participant identified a clinician to serve as a collaborating “spoke” site to perform local safety monitoring. Study participants traveled to the hub at the beginning and end of each study arm, and to their individual spoke site in the intervening weeks. Results A total of 18 spoke sites were established for 19 enrolled study participants. One potential participant was unable to identify a collaborating local site and was thus unable to participate. Study start-up required a median 6.7 months (interquartile range = 4.6–9.2 months). Only 33.3% (n = 6 of 18) of spoke site investigators had prior clinical trial experience, thus close collaboration with respect to study startup, training, and oversight was an important requirement. All but one participant completed all study visits; no study visits were missed due to travel requirements. Conclusions This study represents a step toward local trial participation for patients with rare diseases. Even in the context of close oversight, local participation models may be best suited for studies of compounds with well-understood side-effect profiles, for those with straightforward modes of administration, or for studies requiring extended follow-up periods.

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.

Screening cancer patients for clinical trial eligibility: A randomized study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6529-6529
Author(s):  
J. Wright ◽  
T. Whelan ◽  
J. Julian ◽  
M. Simunovic ◽  
M. Levine
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Primary Outcome ◽  
Randomized Study ◽  
Secondary Analysis ◽  
Chi Square ◽  
Ongoing Research ◽  
Number Of Patients ◽  
The Difference

6529 Background: The overall proportion of cancer patients enrolled into clinical trials is undesirably low. Research suggests many aspects of the recruitment process can be improved. The present study was undertaken to evaluate the benefit of identifying potentially eligible (PE) clinical trial patients for physicians. Methods: Consenting physicians were randomized to 26 weeks of screening support or not, and were then crossed-over to the other strategy for a second 26-week time period. A computer program reviewed new patient consultations to identify PE clinical trial patients. Physicians receiving support were provided with written individualized details of patient eligibility for trials prior to their medical consultation. The primary outcome of interest was the difference, by physician, in the number of patients who were approached for consent to enter a clinical trial. Results: Thirty-six physicians participated in the 52-week study. 5051 consultations were screened in a blinded fashion, 2,376 when physicians had support and 2,675 when they did not. 939 of 2,376 (39.5%) consultations were identified as involving PE patients when physicians were receiving support, and 1,061 of 2,675 (39.7%) when without. The primary outcome of the study, by physician, did not demonstrate a statistically significant improvement, with 4.1 patients per physician without vs. 4.7 patients with screening support (p>0.05). Secondary analysis demonstrated that the overall proportion of patients approached with the clinical trial option increased from 149/2,675 (5.6%) to 169/2,376 (7.1%) with screening support (Chi-square, p=0.024) and that the number of patients that entered a clinical trial also increased from 60/2,675 (2.2%) to 83/2,376 (3.5%) (Chi-square, p=0.007). Conclusions: This study suggests that individualized patient screening for clinical trial eligibility may be useful to improve the numbers of patients approached to consider clinical trials. The number of new patients that entered clinical trials remained low, and ongoing research to facilitate improvements is required. No significant financial relationships to disclose.

Barriers to participation in breast cancer trials

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6593-6593
Author(s):  
O. Herasme ◽  
J. Goldberg ◽  
R. Sandoval ◽  
C. Harris ◽  
Y. Ortiz-Pride ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Child Care ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Demographic Factors ◽  
Trial Participation ◽  
Barriers To Participation ◽  
Cancer Trials

6593 Background: Clinical cancer trials allow investigators to test the effectiveness and safety of new cancer drugs and treatments. Historically, fewer that 5% of cancer patients have participated in clinical trials. The purpose of this study was to assess attitudes, beliefs, and practical barriers to clinical trial recruitment. Methods: Women were recruited in the Herbert Irving Comprehensive Cancer Center while waiting for routine breast screening or for oncology care in connection with a diagnosis of breast cancer. The 29-item survey questionnaire covered demographic factors, prior cancer diagnosis or risk factors, past experience with clinical trials if any, willingness to participate in different types of trials, and attitudinal and practical barriers to participation. Results: Of 329 respondents, 48.9% were non- Hispanic white, 10.9% non-Hispanic black, 34.9% Hispanic, and 5.30% other/unknown. The mean age of participants was 52.5 (SD=12.1). Of 131 (39.8%) participants reporting that they had been asked to participate in clinical trial, 82 were white, 17 black and 32 Hispanic. Of those who enrolled, 64 were white, 14 were black, and 19 Hispanic. Of those asked to participate 56/63 breast cancer patients (88.9%) and 44/68 others (64.7%) enrolled (P=0.002). Of 48 who reported that they had child care responsibilities, 33 enrolled (68.8) compared to 67/83 (80.7%) of those without such responsibilities (P=0.07). Of the total sample, 88/220 (40.0%) of those without childcare responsibilities but only 32/109 (29.4) said they would be willing to participate in a placebo-controlled trial. Respondents were twice as likely to say they would participate in a trial comparing two active agents as a placebo-controlled trial. Conclusion: Our findings suggest that being asked to participate in a clinical trial may be associated with demographic factors, and that specific circumstances, such as child care responsibilities, may also affect trial participation. Awareness of these barriers may help investigators to develop effective strategies for overcoming them and for improving trial participation overall. No significant financial relationships to disclose.

scholarly journals Bayesian Adaptive Randomized Trial Design for Patients With Recurrent Glioblastoma

2012 ◽  
Vol 30 (26) ◽  
pp. 3258-3263 ◽  
Author(s):  
Lorenzo Trippa ◽  
Eudocia Q. Lee ◽  
Patrick Y. Wen ◽  
Tracy T. Batchelor ◽  
Timothy Cloughesy ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Survival Data ◽  
Trial Design ◽  
Statistical Power ◽  
Power Level ◽  
Recurrent Glioblastoma ◽  
Phase Ii Trials ◽  
Number Of Patients ◽  
Short Time

Purpose To evaluate whether the use of Bayesian adaptive randomized (AR) designs in clinical trials for glioblastoma is feasible and would allow for more efficient trials. Patients and Methods We generated an adaptive randomization procedure that was retrospectively applied to primary patient data from four separate phase II clinical trials in patients with recurrent glioblastoma. We then compared AR designs with more conventional trial designs by using realistic hypothetical scenarios consistent with survival data reported in the literature. Our primary end point was the number of patients needed to achieve a desired statistical power. Results If our phase II trials had been a single, multiarm trial using AR design, 30 fewer patients would have been needed compared with a multiarm balanced randomized (BR) design to attain the same power level. More generally, Bayesian AR trial design for patients with glioblastoma would result in trials with fewer overall patients with no loss in statistical power and in more patients being randomly assigned to effective treatment arms. For a 140-patient trial with a control arm, two ineffective arms, and one effective arm with a hazard ratio of 0.6, a median of 47 patients would be randomly assigned to the effective arm compared with 35 in a BR trial design. Conclusion Given the desire for control arms in phase II trials, an increasing number of experimental therapeutics, and a relatively short time for events, Bayesian AR designs are attractive for clinical trials in glioblastoma.

scholarly journals Clinical trial participation in America: The roles of eHealth engagement and patient–provider communication

2021 ◽  
Vol 7 ◽  
pp. 205520762110676
Author(s):  
Shaohai Jiang ◽  
Y. Alicia Hong
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
The United States ◽  
Equation Modeling ◽  
Trial Participation ◽  
Provider Communication ◽  
Clinical Trial Participation ◽  
Patient Centered ◽  
Targeted Interventions ◽  
Patient Provider Communication

Objective Public participation in a clinical trial is the foundation of clinical research and the cornerstone for the discovery of new treatment and improving health outcomes. This study aims to examine how eHealth engagement, patient–provider communication, and clinical trial knowledge are associated with clinical trial participation in the United States. Methods Data were drawn from the Health Information National Trends Survey Iteration 5 Cycle 4 conducted in 2020. The sample included 3865 American adults aged 18 years and above. Path analysis using structural equation modeling and hierarchical linear regression was performed to examine the effects of eHealth engagement and patient–provider communication on clinical trial participation. Results About 5% of American adults have ever participated in a clinical trial. Younger adults, males, minorities, and people with lower education, less clinical trial knowledge, and less eHealth engagement were less likely to participate. After controlling for demographic variables, we found that more eHealth engagement led to a better knowledge of clinical trials, which was strongly associated with participation. Further, patient-centered communication did not directly lead to clinical trial participation; instead, it positively moderated the relationship between clinical trial knowledge and participation. Conclusions The national survey data indicate that American participation in clinical trials remains low and a significant disparity exists. Within the context of the eHealth movement, it is critical to implement targeted interventions to improve clinical trial knowledge, address the digital divide, and enhance patient-centered communication.

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.

Transforming Clinical Trial Eligibility Criteria to Reflect Practical Clinical Application

2016 ◽  
pp. 83-90 ◽  
Author(s):  
Edward S. Kim ◽  
Jennifer Atlas ◽  
Gwynn Ison ◽  
Jennifer L. Ersek
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Diagnostic Testing ◽  
Standard Of Care ◽  
Trial Participation ◽  
Eligibility Criteria ◽  
Number Of Patients ◽  
Oncology Clinical Trials ◽  
Clinical Trial Accrual ◽  
Clinical Trial Results

Historically, oncology clinical trials have focused on comparing a new drug’s efficacy to the standard of care. However, as our understanding of molecular pathways in oncology has evolved, so has our ability to predict how patients will respond to a particular drug, and thus comparison with a standard therapy has become less important. Biomarkers and corresponding diagnostic testing are becoming more and more important to drug development but also limit the type of patient who may benefit from the therapy. Newer clinical trial designs have been developed to assess clinically meaningful endpoints in biomarker-enriched populations, and the number of modern, molecularly driven clinical trials are steadily increasing. At the same time, barriers to clinical trial enrollment have also grown. Many barriers contribute to nonenrollment in clinical trials, including patient, physician, institution, protocol, and regulatory barriers. At the protocol level, eligibility criteria have become a large roadblock to clinical trial accrual. Over time, eligibility criteria have become more and more restrictive. To accrue an adequate number of patients to molecularly driven trials, we should consider eligibility criteria carefully and attempt to reduce restrictive criteria. Reducing restrictive eligibility criteria will allow more patients to be eligible for clinical trial participation, will likely increase the speed of drug approvals, and will result in clinical trial results that more accurately reflect treatment of the population in the clinical setting.

scholarly journals Psychosocial and Functional Distress of Cancer Patients in A Tertiary Care Hospital: A Descriptive Cross-sectional Study

2019 ◽  
Vol 57 (218) ◽  
Author(s):  
Guru Sharan Sah
Keyword(s):  
Cancer Patients ◽  
Stage Iv ◽  
Cross Sectional Study ◽  
Distress Thermometer ◽  
Care Hospital ◽  
Care Providers ◽  
Sectional Study ◽  
Cross Sectional ◽  
Number Of Patients ◽  
Patient Department

Introduction: Global burden of cancer is witnessing an exponential increase. Nepal is no exception. In the recent years, cancer care has seen a focus shift towards holistic healing. This includes screening and assessing for psychosocial distress, allowing health care providers to deliver timely psychological interventions. The goal of this study was to find the prevalence of psychosocial and functional impact of cancer diagnoses in Nepal. Methods: A descriptive cross-sectional study was carried out on 169 cancer patients attending out-patient department, day-care and in-patient department at B.P. Koirala Memorial Cancer Hospital, Nepal. National Comprehensive Cancer Network Distress Thermometer was used to evaluate spiritual/religious concerns, practical, family, emotional and physical issues and the distress score of these patients. Results: One-hundred and thirty eight (81.7%) of respondents had a Distress Thermometer score of ≥4. Distress Thermometer score of 7 was reported by the largest number of patients. Highest average Distress Thermometer scores were found in patients with hepatobiliary, head & neck and lung cancers. More than 50% of the patients reported to experience spiritual or religious concerns, fatigue, pain, worry and insurance or financial related concerns. Pain, sadness, worry and spiritual/religious concerns were significantly associated with distress levels. Sixty-two (36.7%) of respondents were in stage IV of cancer. Average Distress Thermometer score for patients in stage IV cancer was 5.69, the highest among all cancer stages. Ninety-six (56.8%) of the respondents were females, 73 (43.2%) were males. Gynaecological, haematological, gastrointestinal, head & neck and breast cancers were the top 5 cancer types. Conclusions: Cancer patients in Nepal have clinically significant psychosocial issues that directly impact on their distress.

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