Korean Cancer Patients’ Awareness of Clinical Trials, Perceptions on the Benefit and Willingness to Participate

Lim, Yoojoo; Lim, Jee Min; Jeong, Won Jae; Lee, Kyung Hun; Keam, Bhumsuk; Kim, Tae Yong; Han, Sae Won; Oh, Do Youn; Kim, Dong Wan; Heo, Dae Seog; Bang, Yung Jue; Im, Seock Ah

doi:10.4143/crt.2016.413

Cited by 15 publications

(10 citation statements)

References 18 publications

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“…This remarkable growth was fuelled by state-led policies, such as establishing criteria for clinical trials practices that were pursuant to the International Conference on Harmonisation Good Clinical Practice in 2000, introducing the Investigational New Drug application in 2002, initiating the operation of Regional Clinical Trial Centres in 2004, and launching the Korean National Enterprise for Clinical Trials in 2007. Social recognition of clinical trials has also increased; shares of Korean who were aware of the concept of clinical trial have raised 83% out of 524 persons in 2007 [3], 94% out of 137 in 2009 [4], and 97% out of 397 in 2012–2015 [5].…”

Section: Introductionmentioning

confidence: 99%

Challenges in informed consent decision-making in Korean clinical research: A participant perspective

Choi

Lee

2019

PLoS ONE

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Objectives This study investigated how the essential elements of informed consent are realised during the consent process and examined the challenges in obtaining genuine informed consent in Korea. Methods Through purposive sampling, we recruited 21 subjects from those participating in anticancer drug research since 2013. We undertook 1:1 in-depth interviews and analysed the data by framework analysis. Results Themes raised throughout the interviews were categorised into ‘disclosure’ and ‘understanding’ of clinical information and ‘decision’. Provider-centred information, both verbal and written, was delivered to each participant. There were few tools that the research staff might evaluate study participants’ level of understanding of the provided information during the clinical trial. Although participants did not understand basic clinical trial concepts as much as desired, they may not seek to solve difficulties through communication with trial researchers. Doubts were raised about whether participants had sufficient capacity and free will to provide informed consent. Conclusion There is a concern that informed consent can fall short of genuine in Korea. To ensure informed consent meets the international standard, greater efforts should be made to establish an explicit standard operational protocol for obtaining informed consent.

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Section: Introductionmentioning

confidence: 99%

Challenges in informed consent decision-making in Korean clinical research: A participant perspective

Choi

Lee

2019

PLoS ONE

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“…Depression was also reported in a review of phase I clinical trials. 2 In addition, many participants in clinical trials have a relatively poor understanding of the process, which can impose a psychological burden after the occurrence of serious adverse events (SAEs), 3 defined as an adverse medical event that occurs in response to any dose of a drug, including death, life threatening illness, inpatient hospitalization or prolonged hospitalization, persistent or significant disability/incapacity, and congenital anomalies/birth defects. 4 In clinical trials, SAEs are an important measure of drug safety and they can lead to discontinuation of treatment, hospitalization, or death.…”

Section: Introductionmentioning

confidence: 99%

Depression and anxiety in cancer patient enrolled in clinical trials with serious adverse events

Peng,

Wang,

Sun

et al. 2023

Cancer Medicine

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ObjectiveDrug‐induced side effects, particularly serious adverse events (SAEs), often affect cancer patients enrolled in clinical trials. However, little is known about anxiety and depression in cancer patients who experienced SAEs. This study evaluated the prevalence of anxiety and depression in cancer patients enrolled in clinical trials who experienced SAEs and explored the risk factors.MethodsA multi‐center, cross‐sectional survey was conducted in hospitals affiliated with the University of Science and Technology of China from December 2021 to November 2022. A total of 112 cancer patients who experienced SAEs while enrolled in clinical trials, and who completed the informed consent process and study questionnaires, were included in the final analysis.ResultsThe rate of moderate–severe depression in cancer patients was 38.4% and that of moderate–severe anxiety was 13.4%. Among the patients who had moderate–severe anxiety, 93.3% had concurrent moderate–severe depression. Lower cognitive function and lower global quality of life were risk factors for depression in cancer patients who experienced SAEs. Pain, low emotional function, low global quality of life, and a high Impact of Events Scale score were risk factors for anxiety.ConclusionsCancer patients enrolled in a clinical trial who experienced SAEs tended to be anxious and depressed, particularly the latter. These results indicate the need to evaluate anxiety and depression, and mental health treatment among cancer patients with SAEs in clinical trials.

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“…Participation in breast cancer trials is increasingly seen as a multifactorial problem, spanning patient-specific [7], social [7,8] and systemic issues such as narrow eligibility criteria and poor access to trials [9]. Studies have identified dozens of factors that might affect participation under different circumstances and for different trials [7,8,[10][11][12][13][14][15]. We propose that a systematic way is needed to identify and address the factors relevant to specific trials (as opposed to trials in general), and then match these factors with recruitment activities (e.g., study advertisement, informed consent processes, participation support) known to address these factors; in essence, forming a tailored 'recruitment strategy' for that specific trial.…”

Section: Introductionmentioning

confidence: 99%

Results from a Theory-Guided Survey to Support Breast Cancer Trial Participation: Barriers, Enablers, and What to Do about them

et al. 2021

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Background: Ensuring adequate, informed, and timely participation in clinical trials is a multifactorial problem. We have previously developed a systematic, tailorable survey development approach that is informed by theory, can identify barriers and enablers to participation, and can suggest recruitment strategies to address these issues. In this study, we surveyed subscribers to the Canadian Breast Cancer Network (CBCN) in order to identify a comprehensive list of theory-informed barriers and enablers relevant to participation in a hypothetical breast cancer trial. Methods: We developed and conducted an online survey of breast cancer patients informed by the Theoretical Domains Framework and designed to determine previous experience with clinical trials, knowledge about clinical trials, and importance of a comprehensive list of barriers and enablers to trial participation. Participants were contacted by email or through social media. Results: From 2451 subscribers of the CBCN, we received 244 responses and 210 completed surveys (244/2451 or 9.9% participation, 210/244 or 86.1% completion). A total of 38% of respondents indicated experience in trial participation, but 83% indicated confidence in their knowledge about clinical trials. Those who had previously participated in clinical trials were more confident in their knowledge (χ2= 6.77, p = 0.009) and answered more knowledge questions (t = −3.90 p = 0.000). Endorsed barriers and enablers to participation included 39 factors across 12 of 14 domains relevant to behaviour change. Our approach identifies barriers that might be meaningfully addressed by careful knowledge provision (‘If I would learn more about my condition’; ‘If I find the trial documents hard to understand’), those that may require other theory-informed approaches to address (‘my feelings about the quality of my drug plan’; ‘my worry over unknown side effects’), and those that may require tailored approaches depending on participant differences such as previous experience in trials (‘If there were patient-friendly decision-making tools to help you make your participation decision’). Discussion: This work demonstrates that a comprehensive, theory-guided survey of barriers and enablers to participation in breast cancer clinical trials is feasible, can lead to detailed knowledge about the issues related to participation in specific trials, and most importantly, can lead to insights about evidence-based ways to better support patient participation.

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Korean Cancer Patients’ Awareness of Clinical Trials, Perceptions on the Benefit and Willingness to Participate

Cited by 15 publications

References 18 publications

Challenges in informed consent decision-making in Korean clinical research: A participant perspective

Challenges in informed consent decision-making in Korean clinical research: A participant perspective

Depression and anxiety in cancer patient enrolled in clinical trials with serious adverse events

Results from a Theory-Guided Survey to Support Breast Cancer Trial Participation: Barriers, Enablers, and What to Do about them

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