scholarly journals Financial Concerns About Participation in Clinical Trials Among Patients With Cancer

2016 ◽  
Vol 34 (5) ◽  
pp. 479-487 ◽  
Author(s):  
Yu-Ning Wong ◽  
Mark D. Schluchter ◽  
Terrance L. Albrecht ◽  
Al Bowen Benson ◽  
Joanne Buzaglo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Sex Education ◽  
Self Efficacy ◽  
Secondary Data ◽  
Decisional Conflict ◽  
Decision Quality ◽  
Patients With Cancer ◽  
Financial Concern

Purpose The decision to enroll in a clinical trial is complex given the uncertain risks and benefits of new approaches. Many patients also have financial concerns. We sought to characterize the association between financial concerns and the quality of decision making about clinical trials. Methods We conducted a secondary data analysis of a randomized trial of a Web-based educational tool (Preparatory Education About Clinical Trials) designed to improve the preparation of patients with cancer for making decisions about clinical trial enrollment. Patients completed a baseline questionnaire that included three questions related to financial concerns (five-point Likert scales): “How much of a burden on you is the cost of your medical care?,” “I'm afraid that my health insurance won't pay for a clinical trial,” and “I’m worried that I wouldn’t be able to afford the costs of treatment on a clinical trial.” Results were summed, with higher scores indicating greater concerns. We used multiple linear regressions to measure the association between concerns and self-reported measures of self-efficacy, preparation for decision making, distress, and decisional conflict in separate models, controlling for sociodemographic characteristics. Results One thousand two hundred eleven patients completed at least one financial concern question. Of these, 27% were 65 years or older, 58% were female, and 24% had a high school education or less. Greater financial concern was associated with lower self-efficacy and preparation for decision making, as well as with greater decisional conflict and distress, even after adjustment for age, race, sex, education, employment, and hospital location (P < .001 for all models). Conclusion Financial concerns are associated with several psychological constructs that may negatively influence decision quality regarding clinical trials. Greater attention to patients’ financial needs and concerns may reduce distress and improve patient decision making.

scholarly journals Effects of a Brief Multimedia Psychoeducational Intervention on the Attitudes and Interest of Patients With Cancer Regarding Clinical Trial Participation: A Multicenter Randomized Controlled Trial

2012 ◽  
Vol 30 (20) ◽  
pp. 2516-2521 ◽  
Author(s):  
Paul B. Jacobsen ◽  
Kristen J. Wells ◽  
Cathy D. Meade ◽  
Gwendolyn P. Quinn ◽  
Ji-Hyun Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Self Efficacy ◽  
Psychoeducational Intervention ◽  
Trial Participation ◽  
Willingness To Participate ◽  
Patients With Cancer ◽  
Multicenter Randomized Controlled Trial ◽  
Educational Information

Purpose The negative attitudes of patients with cancer regarding clinical trials are an important contributor to low participation rates. This study evaluated whether a brief psychoeducational intervention was effective in improving patients' attitudes as well as their knowledge, self-efficacy for decision making, receptivity to receiving more information, and general willingness to participate in clinical trials. Patients and Methods A total of 472 adults with cancer who had not been asked previously to participate in a clinical trial were randomly assigned to receive printed educational information about clinical trials or a psychoeducational intervention that provided similar information and also addressed misperceptions and concerns about clinical trials. The primary (attitudes) and secondary outcomes (knowledge, self-efficacy, receptivity, and willingness) were assessed via patient self-report before random assignment and 7 to 28 days later. Results Patients who received the psychoeducational intervention showed more positive attitudes toward clinical trials (P = .016) and greater willingness to participate (P = .011) at follow-up than patients who received printed educational information. Evidence of an indirect effect of intervention assignment on willingness to participate (estimated at 0.168; 95% CI, 0.088 to 0.248) suggested that the benefits of psychoeducation on willingness to participate were explained by the positive impact of psychoeducation on attitudes toward clinical trials. Conclusion A brief psychoeducational intervention can improve the attitudes of patients with cancer toward clinical trials and thereby increase their willingness to participate in clinical trials. Findings support conducting additional research to evaluate effects of this intervention on quality of decision making and rates of participation among patients asked to enroll onto therapeutic clinical trials.

scholarly journals Perceptions of Participation in a Phase I, II, or III Clinical Trial Among African American Patients With Cancer: What Do Refusers Say?

2013 ◽  
Vol 9 (6) ◽  
pp. 287-293 ◽  
Author(s):  
Richard F. Brown ◽  
Debbie L. Cadet ◽  
Robert H. Houlihan ◽  
Maria D. Thomson ◽  
Emily C. Pratt ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
African American ◽  
Phase I ◽  
Family Members ◽  
Patients With Cancer ◽  
Aid Decision ◽  
Physician Recommendations

Low rates of physician recommendations of African American patients to clinical trials warrant further investigation. Interventions to reduce misunderstandings and aid decision making need to target both patients and family members.

scholarly journals ACTA A Tool for Argumentative Clinical Trial Analysis

2019 ◽  
Author(s):  
Tobias Mayer ◽  
Elena Cabrio ◽  
Serena Villata
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Online Discussion ◽  
Trial Analysis ◽  
Persuasive Essays

Argumentative analysis of textual documents of various nature (e.g., persuasive essays, online discussion blogs, scientific articles) allows to detect the main argumentative components (i.e., premises and claims) present in the text and to predict whether these components are connected to each other by argumentative relations (e.g., support and attack), leading to the identification of (possibly complex) argumentative structures. Given the importance of argument-based decision making in medicine, in this demo paper we introduce ACTA, a tool for automating the argumentative analysis of clinical trials. The tool is designed to support doctors and clinicians in identifying the document(s) of interest about a certain disease, and in analyzing the main argumentative content and PICO elements.

Increasing Health Literacy to Improve Clinical Trial Recruitment

2018 ◽  
pp. 94-108
Author(s):  
Saliha Akhtar
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Health Literacy ◽  
Trial Recruitment ◽  
Negative Perception ◽  
Consent Forms ◽  
Clinical Trial Recruitment ◽  
And Training

Health literacy has been found to be linked to healthcare understanding and decision making. Therefore, it makes sense why individuals who do not understand clinical trials will be less likely to want to enroll in one. In fact, three major barriers found in the literature that prevent potential participants from enrolling in clinical trials include a distrust or negative perception, lack of understanding, and lack of accessible and affordable healthcare. Hence, there is a need to increase potential participants' healthcare understanding so that they can make the best healthcare decisions for themselves. Strategies suggested to help increase potential participants' health literacy include revising informed consent forms, utilizing culturally targeted statements, using a variety of material, and training investigative site personnel. These proposed strategies may help increase health literacy, which in turn could improve clinical trial recruitment. Furthermore, these strategies focus on different elements of health literacy and coupled together may bring the most improvement.

Simulation Modeling as a Decision-Making Aid in Economic Evaluation for Randomized Clinical Trials

2011 ◽  
pp. 1738-1758
Author(s):  
Tillal Eldabi ◽  
Robert D. Macredie ◽  
Ray J. Paul
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Economic Evaluation ◽  
Simulation Model ◽  
Randomized Clinical Trial ◽  
Simulation Modeling ◽  
Randomized Clinical Trials ◽  
Healthcare Systems ◽  
Modeling Process

This chapter reports on the use of simulation in supporting decision-making about what data to collect in a randomized clinical trial (RCT). We show how simulation also allows the identification of critical variables in the RCT by measuring their effects on the simulation model’s “behavior.” Healthcare systems pose many of the challenges, including difficulty in understanding the system being studied, uncertainty over which data to collect, and problems of communication between problem owners. In this chapter we show how simulation also allows the identification of critical variables in the RCT by measuring their effects on the simulation model’s “behavior.” The experience of developing the simulation model leads us to suggest simple but extremely valuable lessons. The first relates to the inclusion of stakeholders in the modeling process and the accessibility of the resulting models. The ownership and confidence felt by stakeholders in our case is, we feel, extremely important and may provide an example to others developing models.

scholarly journals Provider Recommendations for Phase I Clinical Trials Within a Shared Decision-Making Model in Phase I Cancer Clinical Trial Discussions

2020 ◽  
Vol 16 (9) ◽  
pp. e859-e867
Author(s):  
Rachel S. Hianik ◽  
Gavin P. Campbell ◽  
Eli Abernethy ◽  
Colleen Lewis ◽  
Christina S. Wu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Phase I ◽  
Shared Decision Making ◽  
Phase I Trial ◽  
Performance Status ◽  
Shared Decision ◽  
Phase I Clinical Trials ◽  
Decision Making Model

PURPOSE: Debate continues over whether explicit recommendations for a clinical trial should be included as an element of shared decision making within oncology. We aimed to determine if and how providers make explicit recommendations in the setting of phase I cancer clinical trials. METHODS: Twenty-three patient/provider conversations about phase I trials were analyzed to determine how recommendations are made and how the conversations align with a shared decision-making framework. In addition, 19 providers (9 of whose patient encounters were observed) were interviewed about the factors they consider when deciding whether to recommend a phase I trial. RESULTS: We found that providers are comprehensive in the factors they consider when recommending clinical trials. The two most frequently stated factors were performance status (89%) and patient preferences (84%). Providers made explicit recommendations in 19 conversations (83%), with 12 of those being for a phase I trial (12 [63%] of 19). They made these recommendations in a manner consistent with a shared decision-making model; 18 (95%) of the 19 conversations during which a recommendation was made included all steps, or all but 1 step, of shared decision making, as did 11 of the 12 conversations during which a phase I trial was recommended. In 7 (58%) of these later conversations, providers also emphasized the importance of the patient’s opinion. CONCLUSION: We suggest that providers not hesitate to make explicit recommendations for phase I clinical trials, because they are able to do so in a manner consistent with shared decision making. With further research, these results can be applied to other clinical trial settings.

Relationship Between Parental Intolerance of Uncertainty and Decisional Conflict in Pediatric Otolaryngologic Surgery

2020 ◽  
pp. 019459982097364
Author(s):  
Chelsea Cleveland ◽  
Vijay A. Patel ◽  
Shari A. Steinman ◽  
Reena Razdan ◽  
Michele M. Carr
Keyword(s):  
Decision Making ◽  
Shared Decision Making ◽  
Sex Education ◽  
Short Form ◽  
Intolerance Of Uncertainty ◽  
Decisional Conflict ◽  
Shared Decision ◽  
Cross Sectional ◽  
Pediatric Otolaryngology ◽  
State Worry

Objective To assess the relationship between depression, anxiety, stress, worry, intolerance of uncertainty (IU), and shared decision making (SDM) in parents of pediatric otolaryngology surgical patients with their perceptions of decisional conflict (DC). Study Design Cross-sectional. Setting Academic pediatric otolaryngology outpatient clinic. Methods Participants were legal guardians of pediatric patients who met criteria for otolaryngologic surgery. Participants completed a demographic survey as well as validated Decisional Conflict Scale (DCS); Shared Decision-Making Scale (SDMS); Depression, Anxiety and Stress Scale–21 (DASS-21); Penn State Worry Questionnaire (PSWQ); and short form of the Intolerance of Uncertainty Scale (IUS-12). Results A total of 114 participants were enrolled. Respondents were predominantly female (93.0%) and married (60.5%). Most guardians had not consented previously for otolaryngologic surgery for their child (69.3%). Participants reported low levels of DC and depression as well as moderate levels of anxiety and stress. DC scores were not significantly correlated to DASS-21, PSWQ, or SDM. IUS-12 Total and subscale IUS-12 prospective negatively correlated with Total DC. DC was not related to age, sex, education level, previous otolaryngologic surgery, or type of surgery recommended. Conclusion In this group, an association was found between IU and DC. Clinicians should be aware that DC is not modified by previous surgical experience. Interventions aimed at addressing parental IU related to surgery may reduce DC. Further research efforts could help us understand how mental health relates to surgical decision making.

Artificial Intelligence Tool for Optimizing Eligibility Screening for Clinical Trials in a Large Community Cancer Center

2020 ◽  
pp. 50-59 ◽  
Author(s):  
J. Thaddeus Beck ◽  
Melissa Rammage ◽  
Gretchen P. Jackson ◽  
Anita M. Preininger ◽  
Irene Dankwa-Mullan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Language Processing ◽  
Medical Records ◽  
Cancer Center ◽  
Patients With Cancer ◽  
Attribute Extraction ◽  
Time Required ◽  
Manual Review

PURPOSE Less than 5% of patients with cancer enroll in clinical trials, and 1 in 5 trials are stopped for poor accrual. We evaluated an automated clinical trial matching system that uses natural language processing to extract patient and trial characteristics from unstructured sources and machine learning to match patients to clinical trials. PATIENTS AND METHODS Medical records from 997 patients with breast cancer were assessed for trial eligibility at Highlands Oncology Group between May and August 2016. System and manual attribute extraction and eligibility determinations were compared using the percentage of agreement for 239 patients and 4 trials. Sensitivity and specificity of system-generated eligibility determinations were measured, and the time required for manual review and system-assisted eligibility determinations were compared. RESULTS Agreement between system and manual attribute extraction ranged from 64.3% to 94.0%. Agreement between system and manual eligibility determinations was 81%-96%. System eligibility determinations demonstrated specificities between 76% and 99%, with sensitivities between 91% and 95% for 3 trials and 46.7% for the 4th. Manual eligibility screening of 90 patients for 3 trials took 110 minutes; system-assisted eligibility determinations of the same patients for the same trials required 24 minutes. CONCLUSION In this study, the clinical trial matching system displayed a promising performance in screening patients with breast cancer for trial eligibility. System-assisted trial eligibility determinations were substantially faster than manual review, and the system reliably excluded ineligible patients for all trials and identified eligible patients for most trials.

scholarly journals Patients with cancer in the COVID-19 era: the clinical trial issue

2020 ◽  
Vol 106 (4) ◽  
pp. 271-272 ◽  
Author(s):  
Marcello Scarcia ◽  
Giuseppe Mario Ludovico ◽  
Angela Fortunato ◽  
Alba Fiorentino
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Physical Examination ◽  
Regulatory Agencies ◽  
Study Medication ◽  
Therapeutic Modalities ◽  
Patients With Cancer ◽  
Safety Guidelines ◽  
Trial Discontinuation

Coronavirus disease 2019 (COVID-19) hospital reorganization may result in reduced ability for the hospital to fully use its armamentarium for battling cancer. Thus different therapeutic modalities have been recommended. During the pandemic, despite regulatory agencies’ recommendations, several considerations and doubts remain for oncologic clinical trials. Considering patients who had been enrolled before the pandemic, and who plan to take the study medication, the situation becomes complicated. These patients should undergo monitoring visits, blood sampling, questionnaire, physical examination, and drug and radiation administration. To avoid deviations from the protocol and trial discontinuation, follow-up should be performed regularly, in concordance with safety guidelines. Here we report several considerations.

scholarly journals INFORMED CONSENT IN CLINICAL TRIALS FOR PERSONS WITH DEMENTIA

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S28-S28 ◽  
Author(s):  
Joan G Carpenter
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Nursing Homes ◽  
Decision Maker ◽  
Surrogate Decision Maker ◽  
Decision Making Capacity ◽  
Consent Document ◽  
Surrogate Decision

Abstract Informed consent is one of the most important processes during the implementation of a clinical trial; special attention must be given to meeting the needs of persons with dementia in nursing homes who have impaired decision making capacity. We overcame several challenges during enrollment and consent of potential participants in a pilot clinical trial including: (1) the consent document was designed for legally authorized representatives however some potential participants were capable of making their own decisions; (2) the written document was lengthy yet all seven pages were required by the IRB; (3) the required legal wording was difficult to understand and deterred potential participants; and (4) the primary mode of communication was via phone. We tailored assent and informed consent procedures to persons with dementia and their legally authorized representative/surrogate decision maker to avoid risking an incomplete trial and to improve generalizability of trial results to all persons with dementia.

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