Strategies to Maximize Patient Participation in Clinical Trials

2017 ◽  
pp. 216-221
Author(s):  
Eric H. Rubin ◽  
Mary J. Scroggins ◽  
Kirsten B. Goldberg ◽  
Julia A. Beaver
Keyword(s):  
Clinical Trials ◽  
Patient Participation ◽  
Patient Perspective ◽  
Heterogeneous Population ◽  
Patient Access ◽  
Eligibility Criteria ◽  
Enrollment Rate ◽  
Patients With Cancer ◽  
Multiple Obstacles ◽  
Oncology Drug Development

Despite considerable interest and success in oncology drug development, the minority of patients with cancer diagnoses enroll in clinical trials. Multiple obstacles account for this low enrollment rate. An improvement in patient participation in clinical trials could increase patient access to novel and potentially promising agents, provide faster trial results, and, with implementation of rational eligibility criteria, allow for a better understanding of the drug’s safety and efficacy in a heterogeneous population. We present barriers and potential solutions to maximize patient participation, including a review of the ASCO and Friends of Cancer Research (FoCR) Modernizing Eligibility Criteria Project, U.S. Food and Drug Administration (FDA) regulatory considerations, an industry perspective, and a patient perspective.

Evaluation of the inclusion rate in clinical trials of bladder cancer patients evaluated for first time in the oncology department.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19219-e19219
Author(s):  
Natalia Vidal ◽  
Javier Puente ◽  
Fernando Moreno ◽  
María del Rosario Alfonso ◽  
Lydia Suárez ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Supportive Care ◽  
Cancer Patients ◽  
The Elderly ◽  
Eligibility Criteria ◽  
Enrollment Rate ◽  
Geriatric Evaluation ◽  
Inclusion Rate ◽  
First Time

e19219 Background: In the Genitourinary (GU) Cancer Unit of Clínico San Carlos Hospital the inclusion rate in Clinical-Trials (CTs) from January-October 2018 was 39%. However, in bladder cancer patients it was only 24%. We identified improvement areas in order to increase the inclusion rate of these patients up to 30% from November 2018-March 2019. Methods: We used as an instrument the American Society of Clinical Oncology (ASCO) Quality Training Program (QTP). We collected the number of proposals and available CTs, the number of bladder cancer patients evaluated for the first time and the patients enrolled in CTs. We also identified the causes of non-enrollment and elaborated a list of possible solutions. Results: We developed a cause-effect diagram showing that the most relevant causes of non-enrollment in CTs were the eligibility criteria (60%) and the absence of available CTs (35%). We created a list of measures and identified which would have a higher impact. On November 2018 we started a protocolized Supportive-Care evaluation by our Oncology nurses to increase the number of eligible patients. We also initiated the diffusion of CTs in the Investigation Unit and in the GU-board to increase the number of available CTs and recruitment. In January 2019 we implemented a Geriatric evaluation for the elderly, also to increase the number of eligible patients. With these measures the number of accepted trials increased from 5 in January-October 2018 to 12 in November 2018-March 2019. Also, in January-October 2018, 46% of patients were not-enrolled in a CT due to ineligibility, which decreased to 25% from November 2018-March 2019. As a result, the enrollment rate increased to 43, 75% from November 2018-March 2019. We maintained the measures, and achieved an enrollment rate of 54, 83% from May-December 2019. Conclusions: The implementation of a Supportive-Care and a Geriatric evaluation, and the diffusion of CTs helped increase the percentage of eligible patients and the number of available CTs. With these improvements, we were able to increase the enrollment rate in CTs from 24 to 58, 83%.

Barriers and facilitators to oncology clinical trial accrual: Comparing perceptions of community and academic oncologists.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18131-e18131
Author(s):  
Andrew R. Wong ◽  
Arti Hurria ◽  
Virginia Sun ◽  
Daneng Li ◽  
Kevin George ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Barriers And Facilitators ◽  
Structured Interviews ◽  
Eligibility Criteria ◽  
Patients With Cancer ◽  
Oncology Clinical Trial ◽  
Medical Oncologists ◽  
Academic Practices ◽  
Clinical Trial Accrual

e18131 Background: Multiple studies have described the barriers and facilitators to oncology clinical trial accrual in academic practices. However, few studies have been done in community settings, even though the majority of patients with cancer receive their care in the community. We examined and compared community and academic oncologists’ perceptions of the barriers and facilitators to cancer clinical trial accrual. Methods: Semi-structured interviews were conducted from March to June 2018 with 44 medical oncologists at City of Hope (24 in academia; 20 in community sites). Purposive sampling was used to ensure participant diversity. Primary measures were oncologists’ self-reported perceptions of the barriers and facilitators to clinical trial accrual. Responses were recorded digitally, transcribed, and de-identified. Data was managed using NVivo v12. Two analysts coded the interview data using thematic content analysis (kappa = 0.74). A third analyst adjudicated discrepancies. Results: Of the 44 participants, 36% were women, and 68% had > 10 years of experience. Compared to academic oncologists, community oncologists more often cited barriers due to the lack of protocols suitable for community patients’ histology and stage (13% vs. 6%) and insufficient trial personnel support (13% vs. 9%). Compared to community oncologists, academic oncologists more often cited barriers due to limited time (14% vs. 8%) and overly stringent eligibility criteria (14% vs. 9%). Community oncologists more commonly reported extrinsic facilitators (e.g. reminders of available protocols from trial support staff) (91% vs. 76%) while academic oncologists more commonly reported intrinsic facilitators for offering clinical trials (e.g. self-motivation to prioritize clinical trials) (24% vs. 9%). Conclusions: Community oncologists more often reported facing barriers to accrual due to limited suitable trials and insufficient personnel support compared to academic oncologists. Additionally, community oncologists cite the need for more infrastructure to support accrual. Interventions to increase trial accrual must be tailored to address the unique needs of both community and academic practices.

scholarly journals Development and Evaluation of a Digital Intervention for Fulfilling the Needs of Older Migrant Patients With Cancer: User-Centered Design Approach (Preprint)

2020 ◽  
Author(s):  
Hande Sungur ◽  
Nida Gizem Yılmaz ◽  
Brittany Ming Chu Chan ◽  
Maria E T C van den Muijsenbergh ◽  
Julia C M van Weert ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Patient Education ◽  
Patient Participation ◽  
Health Care Professionals ◽  
Psychosocial Support ◽  
Mother Tongue ◽  
Patient Rights ◽  
Ease Of Use ◽  
Patients With Cancer

BACKGROUND Older migrant patients with cancer face many language- and culture-related barriers to patient participation during medical consultations. To bridge these barriers, an eHealth tool called <i>Health Communicator</i> was developed in the Netherlands. Essentially used as a digital translator that can collect medical history information from patients, the Health Communicator did not include an oncological module so far, despite the fact that the prevalence of Dutch migrant patients with cancer is rising. OBJECTIVE This study aims to systematically develop, implement, and conduct a pilot evaluation of an oncological module that can be integrated into the Health Communicator to stimulate patient participation among older Turkish-Dutch and Moroccan-Dutch patients with cancer. METHODS The Spiral Technology Action Research model, which incorporates 5 cycles that engage key stakeholders in intervention development, was used as a framework. The <i>listen</i> phase consisted of a needs assessment. The <i>plan</i> phase consisted of developing the content of the oncological module, namely the question prompt lists (QPLs) and scripts for patient education videos. On the basis of pretests in the <i>do</i> phase, 6 audiovisual QPLs on <i>patient rights</i>, <i>treatment</i>, <i>psychosocial support</i>, <i>lifestyle and access to health care services</i>, <i>patient preferences</i>, and <i>clinical trials</i> were created. Additionally, 5 patient education videos were created about <i>patient rights</i>, <i>psychosocial support</i>, <i>clinical trials</i>, and <i>patient-professional communication</i>. In the <i>study</i> phase, the oncological module was pilot-tested among 27 older Turkish-Dutch and Moroccan-Dutch patients with cancer during their consultations. In the <i>act</i> phase, the oncological model was disseminated to practice. RESULTS The <i>patient rights</i> QPL was chosen most often during the pilot testing in the <i>study</i> phase. Patients and health care professionals perceived the QPLs as easy to understand and useful. There was a negative correlation between the tool’s ease of use and patient age. Patients reported that using the module impacted the consultations positively and thought they were more active compared with previous consultations. Health care professionals also found patients to be more active than usual. Health care professionals asked significantly more questions than patients during consultations. Patients requested to see the <i>patients’ rights</i> video most often. Patients rated the videos as easy to understand, useful, and informative. Most of the patients wanted to use the tool in the future. CONCLUSIONS Older migrant patients with cancer, survivors, and health care professionals found the oncological module to be a useful tool and have shown intentions to incorporate it into future consultation sessions. Both QPLs and videos were evaluated positively, the latter indicating that the use of narratives to inform older, low-literate migrant patients with cancer about health-related topics in their mother tongue is a viable approach to increase the effectiveness of health care communication with this target group.

scholarly journals Development and Evaluation of a Digital Intervention for Fulfilling the Needs of Older Migrant Patients With Cancer: User-Centered Design Approach

10.2196/21238 ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. e21238
Author(s):  
Hande Sungur ◽  
Nida Gizem Yılmaz ◽  
Brittany Ming Chu Chan ◽  
Maria E T C van den Muijsenbergh ◽  
Julia C M van Weert ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Patient Education ◽  
Patient Participation ◽  
Health Care Professionals ◽  
Psychosocial Support ◽  
Mother Tongue ◽  
Patient Rights ◽  
Study Phase ◽  
Patients With Cancer

Background Older migrant patients with cancer face many language- and culture-related barriers to patient participation during medical consultations. To bridge these barriers, an eHealth tool called Health Communicator was developed in the Netherlands. Essentially used as a digital translator that can collect medical history information from patients, the Health Communicator did not include an oncological module so far, despite the fact that the prevalence of Dutch migrant patients with cancer is rising. Objective This study aims to systematically develop, implement, and conduct a pilot evaluation of an oncological module that can be integrated into the Health Communicator to stimulate patient participation among older Turkish-Dutch and Moroccan-Dutch patients with cancer. Methods The Spiral Technology Action Research model, which incorporates 5 cycles that engage key stakeholders in intervention development, was used as a framework. The listen phase consisted of a needs assessment. The plan phase consisted of developing the content of the oncological module, namely the question prompt lists (QPLs) and scripts for patient education videos. On the basis of pretests in the do phase, 6 audiovisual QPLs on patient rights, treatment, psychosocial support, lifestyle and access to health care services, patient preferences, and clinical trials were created. Additionally, 5 patient education videos were created about patient rights, psychosocial support, clinical trials, and patient-professional communication. In the study phase, the oncological module was pilot-tested among 27 older Turkish-Dutch and Moroccan-Dutch patients with cancer during their consultations. In the act phase, the oncological model was disseminated to practice. Results The patient rights QPL was chosen most often during the pilot testing in the study phase. Patients and health care professionals perceived the QPLs as easy to understand and useful. There was a negative correlation between the tool’s ease of use and patient age. Patients reported that using the module impacted the consultations positively and thought they were more active compared with previous consultations. Health care professionals also found patients to be more active than usual. Health care professionals asked significantly more questions than patients during consultations. Patients requested to see the patients’ rights video most often. Patients rated the videos as easy to understand, useful, and informative. Most of the patients wanted to use the tool in the future. Conclusions Older migrant patients with cancer, survivors, and health care professionals found the oncological module to be a useful tool and have shown intentions to incorporate it into future consultation sessions. Both QPLs and videos were evaluated positively, the latter indicating that the use of narratives to inform older, low-literate migrant patients with cancer about health-related topics in their mother tongue is a viable approach to increase the effectiveness of health care communication with this target group.

Overcoming Barriers to Clinical Trial Enrollment

2019 ◽  
pp. 105-114 ◽  
Author(s):  
Ryan D. Nipp ◽  
Kessely Hong ◽  
Electra D. Paskett
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Treatment Strategies ◽  
Trial Participation ◽  
Routine Practice ◽  
Clinical Trial Participation ◽  
Eligibility Criteria ◽  
Financial Barriers ◽  
Patients With Cancer ◽  
Clinical Trial Enrollment

Clinical trials are imperative for testing novel cancer therapies, advancing the science of cancer care, and determining the best treatment strategies to enhance outcomes for patients with cancer. However, barriers to clinical trial enrollment contribute to low participation in cancer clinical trials. Many factors play a role in the persistently low rates of trial participation, including financial barriers, logistical concerns, and the lack of resources for patients and clinicians to support clinical trial enrollment and retention. Furthermore, restrictive eligibility criteria often result in the exclusion of certain patient populations, which thus adds to the widening disparities seen between patients who enroll in trials and those treated in routine practice. Moreover, additional factors, such as difficulty by patients and clinicians in coping with the uncertainty inherent to clinical trial participation, contribute to low trial enrollment and represent key components of the decision-making process. Specifically, patients and clinicians may struggle to assess the risk-benefit ratio and may incorrectly estimate the probability and severity of challenges associated with clinical trial participation, thus complicating the informed consent process. Importantly, research has increasingly focused on overcoming barriers to clinical trial enrollment. A promising solution involves the use of patient navigators to help enhance clinical trial recruitment, enrollment, and retention. Although clinical trials are essential for improving and prolonging the lives of patients with cancer, barriers exist that can impede trial enrollment; yet, efforts to recognize and address these barriers and enhance trial enrollment are being investigated.

Systematic Review of Barriers to the Recruitment of Older Patients With Cancer Onto Clinical Trials

2005 ◽  
Vol 23 (13) ◽  
pp. 3112-3124 ◽  
Author(s):  
Carol A. Townsley ◽  
Rita Selby ◽  
Lillian L. Siu
Keyword(s):  
Clinical Trials ◽  
Functional Status ◽  
Older Patients ◽  
Tumor Biology ◽  
Physician Education ◽  
Cancer Clinical Trials ◽  
Comorbid Conditions ◽  
Eligibility Criteria ◽  
Patients With Cancer ◽  
Significant Barrier

Purpose Older patients are significantly underrepresented in cancer clinical trials. A literature review was undertaken to identify the barriers that impede the accrual of this vulnerable population onto clinical trials and to determine what specific strategies are needed to improve the representation of older patients in research studies. Methods A systematic literature search was undertaken using several different strategies to identify relevant articles. Results Nine of 31 relevant papers from 159 citations were included. Age is a significant barrier to recruitment; only a quarter to one third of potentially eligible older patients are enrolled onto trials. Physicians' perceptions, protocol eligibility criteria with restrictions on comorbid conditions, and functional status to optimize treatment tolerability are the most important reasons resulting in the exclusion of older patients. Other barriers include the lack of social support and the need for extra time and resources to enroll these patients. Conversely, older patients do not view their age as an important reason for refusing trials. Conclusion Specific clinical trials confined to older patients should be conducted to evaluate tumor biology, treatment tolerability, and the effect of comorbid conditions. Protocol designs need to stratify for age and be less restrictive with respect to exclusions on functional status, comorbidity, and previous cancers, such that results are generalizable to older patients. Physician education to dispel unfounded perceptions, improved access to available clinical trials, and provision of personnel and resources to accommodate the unique requirements of an older population are possible solutions to remove the barriers of ageism.

Geriatric Oncology and Clinical Trials

2015 ◽  
pp. e127-e131 ◽  
Author(s):  
Stuart M. Lichtman
Keyword(s):  
Clinical Trials ◽  
Older Patients ◽  
Geriatric Oncology ◽  
Life Changes ◽  
Eligibility Criteria ◽  
Patients With Cancer ◽  
Eligibility Assessment ◽  
Dose Limiting Toxicity ◽  
Meaningful Data

The overall aging of the population has resulted in a marked increase in the number of older patients with cancer. These patients have specific needs that are different from those of the younger population. Cancer clinical trials have included an inadequate number of older patients, resulting in lack of meaningful data to make evidence-based decisions for this population. As a result, clinicians have to extrapolate data from younger and healthier patients. There are a number of reasons for this under-representation, including a design and implementation structure for clinical trials that does not meet the needs of this vulnerable population. Issues that need to be addressed include alterations in eligibility criteria to make them less restrictive by accounting for multiple comorbidities and prior malignancy and endpoints specific for older patients, such as quality of life, changes in function, and maintenance of independence. Other issues specific to the older population include alterations in dose-limiting toxicity, measures of treatment-related toxicity, and polypharmacy. Phase I trials can be appropriate for older patients but need to be tailored to their needs. Some form of geriatric assessment needs to be included to help with eligibility, assessment, and stratification. For future clinical trials to be truly meaningful they need to appropriately assess and incorporate the needs of the majority of the cancer population.

scholarly journals Effect of prior cancer on survival of hepatocellular carcinoma: implications for clinical trial eligibility criteria

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xuqi Sun ◽  
Lingling Li ◽  
Li Xu ◽  
Zhongguo Zhou ◽  
Jinbin Chen ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trials ◽  
Cox Regression ◽  
Tumor Stage ◽  
Eligibility Criteria ◽  
Cancer History ◽  
Cox Regression Analysis ◽  
Patients With Cancer ◽  
Kaplan Meier ◽  
Tumor Stages

Abstract Background Patients with cancer history are usually excluded from hepatocellular carcinoma (HCC) clinical trials. However, whether previous malignancy affects the oncological outcomes of HCC patients has not been fully assessed. This study aimed to evaluate whether prior cancer compromised the survival of HCC patients. Methods Patients with HCC were extracted from the Surveillance, Epidemiology, and End Results database between 2004 and 2015, and then they were classified into groups with and without prior cancer. The Kaplan-Meier and multivariate Cox regression analysis were adopted to evaluate whether prior cancer impacted clinical outcomes after propensity score matching (PSM) adjusting baseline differences. Validation was performed in the cohort from our institution. Results We identified 2642 HCC patients with prior cancer. After PSM, the median overall survival (OS) time were 14.5 and 12.0 months respectively for groups with and without prior cancer. Prior cancer did not compromise prognosis in patients with HCC (p = 0.49). The same tendency was found in subgroups stratified by tumor stages and cancer interval period: OS was similar between groups with and without prior cancer (both p values> 0.1). In the multivariate Cox regression model, prior cancer did not adversely impact patients’ survival (HR: 1.024; 95% CI: 0.961–1.092). In the validation cohort from our institution, prior cancer had no significant association with worse outcomes (p = 0.48). Conclusion For HCC patients, prior cancer did not compromise their survival, regardless of tumor stage and cancer interval period. Exclusion criteria for HCC clinical trials could be reconsidered.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

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.

Rationale for heparin treatment of colon cancer

2000 ◽  
Vol 20 (03) ◽  
pp. 136-142 ◽  
Author(s):  
D. L. Ornstein ◽  
L. R. Zacharski
Keyword(s):  
Clinical Trials ◽  
Substantial Improvement ◽  
Patients With Cancer ◽  
Coagulation Mechanism ◽  
Anticoagulant Drug ◽  
Cancer Outcome ◽  
Meta Analyses ◽  
Improvement In Survival ◽  
Spectrum Of Patients ◽  
To Receive

SummaryIt is widely known that the systemic blood coagulation mechanism is often activated in malignancy, leading to an increased incidence of vascular thromboses in patients with cancer. It is not widely appreciated, however, that products of the coagulation mechanism may also support tumor growth and dissemination. Interest in this approach to cancer therapy has surged recently because of mounting evidence that the familiar anticoagulant drug, heparin, may impede tumor progression. Heparin has the capacity to modify angiogenesis, growth factor and protease activity, immune function, cell proliferation and gene expression in ways that may block malignant dissemination. Clinical trials in which heparin has been administered to a broad spectrum of patients to prevent or treat thrombosis have unexpectedly shown improvement in survival in the subset of patients with malignancy entered to these studies. Meta-analyses of clinical trials comparing unfractionated (UF) versus low molecular weight (LMW) heparin treating venous thromboembolism suggest that there may be substantial improvement in cancer outcome in patients with malignancy randomized to receive LMW heparin. These findings provide a rationale for definitive clinical trials of LMW heparin in cancer, and the results of several such studies that are currently underway are awaited with interest.

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