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How Cancer Patients Perceive Clinical Trials (CTs) in the Era of CTs: Current Perception and Its Differences Between Common and Rare Cancers

  • Ji Hyun Park
  • Ji Sung Lee
  • HaYeong Koo
  • Jeong Eun Kim
  • Jin-Hee Ahn
  • Min-Hee Ryu
  • Sook-ryun Park
  • Shin-kyo Yoon
  • Jae Cheol Lee
  • Yong-Sang Hong
  • Sun Young Kim
  • Kyo-Pyo Kim
  • Chang-Hoon Yoo
  • Jung Yong Hong
  • Jae Lyun Lee
  • Kyung Hae Jung
  • Baek-Yeol Rhyoo
  • Tae Won KimEmail author
Article
  • 104 Downloads

Abstract

Perception has recently been highlighted as a critical determinant for participation in clinical trials (CTs) among cancer patients. We evaluated cancer patients’ current perceptions of CTs using the PARTAKE questionnaires, focusing on differences between patients with common and rare cancers. From November 2015 to May 2017, we prospectively surveyed patients who had received anti-cancer treatment at Asan Medical Center. Among 333 respondents, 70.9% had common and 29.1% had rare cancers. In the cohort, 87.7% of patients with common cancers and 75.3% of patients with rare cancers answered that they heard of and knew about CTs. However, willingness to participate in CTs was expressed only in approximately 56% of patients, although it was significantly associated with awareness and perception. Surprisingly, patients with rare cancers when compared with patients with common cancers showed significantly lower levels of awareness and perception (64.2% vs 79.9%, p = 0.003 and 77.3% vs 91.9%, p < 0.001), and consequently less willingness to participate in CTs (47.4% vs 58.9%, p = 0.06). In addition, cancer patients still harbored fear and concerns about safety and reward of CTs, and demonstrated substantial lack of knowledge about the voluntary nature of CTs, which was more obvious in patients with rare cancers. We identified relatively modest willingness of cancer patients to participate in CTs regardless of generally favorable perception. These findings are highlighted by the more negative perception of CTs among patients with rare cancers relative to those with common cancers. Further education and encouragement by research and public entities seem essential to improve motivation of CTs in cancer patients beyond good perception, especially for patients with rare cancers.

Keywords

Clinical trial Current perception Rare cancer Common cancer Difference 

Notes

Acknowledgments

The current research was supported by two grants from the Korea Health Technology R&D Project of the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI14C1061, HI18C2383).

Authors’ Contributions

JHP reviewed the literature, prepared and designed the analysis of data, and drafted and revised the manuscript. JSL, out statistician, made substantial contributions to the methodological process with the whole statistical analysis presented in the study. HYK made a core assistance in directing and proceeding PARTAKE survey and contributed to data management. All other listed co-authors contributed to enrollment of patients for they, as physician oncologist and co-investigators, primarily introduced the scope and aim of the current survey to their patients. TWK initially inspired the conception and design of the study and finally gave final approval of the version to be published. All authors read and approved the final manuscript.

Compliance with Ethical Standards

The study protocol was reviewed and approved by the Institutional Review Board (IRB approval number: 2014-1061) of Asan Medical Center and was conducted in full accordance with the guidelines for Good Clinical Practice and the Declaration of Helsinki.

Conflict of Interest

The authors declare that they have no conflict of interest.

Supplementary material

13187_2019_1494_MOESM1_ESM.docx (135 kb)
ESM 1 (DOCX 135 kb)

References

  1. 1.
    Lara PN Jr, Paterniti DA, Chiechi C, Turrell C, Morain C, Horan N, Montell L, Gonzalez J, Davis S, Umutyan A, Martel CL, Gandara DR, Wun T, Beckett LA, Chen MS Jr (2005) Evaluation of factors affecting awareness of and willingness to participate in cancer clinical trials. J Clin Oncol 23(36):9282–9289CrossRefPubMedGoogle Scholar
  2. 2.
    Lee SJ, Park LC, Lee J, Kim S, Choi MK, Hong JY, Park S, Maeng CH, Chang W, Kim YS, Park SH, Park JO, Lim HY, Kang WK, Park YS (2012) Unique perception of clinical trials by Korean cancer patients. BMC Cancer 12:594CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Lim Y, Lim JM, Jeong WJ, Lee KH, Keam B, Kim TY, Kim TM, Han SW, Oh DY, Kim DW, Kim TY, Heo DS, Bang YJ, Im SA (2017) Korean cancer patients' awareness of clinical trials, perceptions on the benefit and willingness to participate. Cancer Res Treat 49(4):1033–1043CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Kim JW, Kim SJ, Chung YH, Kwon JH, Lee HJ, Chung YJ, Kim YJ, Oh DY, Lee SH, Kim DW, Im SA, Kim TY, Heo DS, Bang YJ (2008) Cancer patients' awareness of clinical trials, perceptions on the benefit and willingness to participate: Korean perspectives. Br J Cancer 99(10):1593–1599CrossRefPubMedPubMedCentralGoogle Scholar
  5. 5.
    Choi YJ, Beck SH, Kang WY, Yoo S, Kim SY, Lee JS, Burt T, Kim TW (2016) Knowledge and perception about clinical research shapes behavior: face to face survey in Korean general public. J Korean Med Sci 31(5):674–681CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Staniszewska A, Lubiejewska A, Czerw A, Dabrowska-Bender M, Duda-Zalewska A, Olejniczak D et al (2018) Awareness and attitudes towards clinical trials among polish oncological patients who had never participated in a clinical trial. Adv Clin Exp Med 27:525–529CrossRefPubMedGoogle Scholar
  7. 7.
    Blakeney N, Michaels M, Green M, Richmond A, Long D, Robinson WS, Spicer C, Elliott-Bynum S, Corbie-Smith G (2015) Collaborative development of clinical trials education programs for African-American community-based organizations. J Cancer Educ 30(2):400–406CrossRefPubMedPubMedCentralGoogle Scholar
  8. 8.
    Panageas KS (2015) Clinical trial design for rare cancers: why a less conventional route may be required. Expert Rev Clin Pharmacol 8(6):661–663CrossRefPubMedPubMedCentralGoogle Scholar
  9. 9.
    Bogaerts J, Sydes MR, Keat N, McConnell A, Benson A, Ho A, Roth A, Fortpied C, Eng C, Peckitt C, Coens C, Pettaway C, Arnold D, Hall E, Marshall E, Sclafani F, Hatcher H, Earl H, Ray-Coquard I, Paul J, Blay JY, Whelan J, Panageas K, Wheatley K, Harrington K, Licitra L, Billingham L, Hensley M, McCabe M, Patel PM, Carvajal R, Wilson R, Glynne-Jones R, McWilliams R, Leyvraz S, Rao S, Nicholson S, Filiaci V, Negrouk A, Lacombe D, Dupont E, Pauporté I, Welch JJ, Law K, Trimble T, Seymour M (2015) Clinical trial designs for rare diseases: studies developed and discussed by the international rare cancers initiative. Eur J Cancer 51(3):271–281CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Casali PG, Bruzzi P, Bogaerts J, Blay JY (2015) Rare cancers Europe (RCE) methodological recommendations for clinical studies in rare cancers: a European consensus position paper. Ann Oncol 26(2):300–306CrossRefPubMedGoogle Scholar
  11. 11.
    Davis LE, Janeway KA, Weiss AR, Chen YE, Scharschmidt TJ, Krailo M et al (2017) Clinical trial enrollment of adolescents and young adults with sarcoma. Cancer 123(18):3434–3440CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    Gatta G, van der Zwan JM, Casali PG, Siesling S, Dei Tos AP, Kunkler I, Otter R, Licitra L, Mallone S, Tavilla A, Trama A, Capocaccia R, RARECARE working group (2011) Rare cancers are not so rare: the rare cancer burden in Europe. Eur J Cancer 47(17):2493–2511CrossRefPubMedGoogle Scholar
  13. 13.
    Shirazee N, Ives A, Collins J, Phillips M, Preen D (2016) Patterns in clinical trial enrollment and supportive care services provision among adolescents and young adults diagnosed with having cancer during the period 2000-2004 in Western Australia. J Adolesc Young Adult Oncol 5(3):254–260CrossRefPubMedGoogle Scholar
  14. 14.
    DeSantis CE, Kramer JL, Jemal A (2017) The burden of rare cancers in the United States. CA Cancer J Clin 67(4):261–272CrossRefPubMedGoogle Scholar
  15. 15.
    Tamaki T, Dong Y, Ohno Y, Sobue T, Nishimoto H, Shibata A (2014) The burden of rare cancer in Japan: application of the RARECARE definition. Cancer Epidemiol 38(5):490–495CrossRefPubMedGoogle Scholar
  16. 16.
    Gagne JJ, Thompson L, O'Keefe K, Kesselheim AS (2014) Innovative research methods for studying treatments for rare diseases: methodological review. BMJ 349:g6802CrossRefPubMedPubMedCentralGoogle Scholar
  17. 17.
    Keat N, Law K, Seymour M, Welch J, Trimble T, Lascombe D, Negrouk A (2013) International rare cancers initiative. Lancet Oncol 14(2):109–110CrossRefPubMedGoogle Scholar
  18. 18.
    Schott AF, Welch JJ, Verschraegen CF, Kurzrock R (2015) The National Clinical Trials Network: conducting successful clinical trials of new therapies for rare cancers. Semin Oncol 42(5):731–739CrossRefPubMedPubMedCentralGoogle Scholar
  19. 19.
    Andre F (2018) Developing anticancer drugs in orphan molecular entities - a paradigm under construction. N Engl J Med 378(8):763–765CrossRefPubMedGoogle Scholar
  20. 20.
    Gaddipati H, Liu K, Pariser A, Pazdur R (2012) Rare cancer trial design: lessons from FDA approvals. Clin Cancer Res 18(19):5172–5178CrossRefPubMedGoogle Scholar
  21. 21.
    Mallone S, De Angelis R, van der Zwan JM, Trama A, Siesling S, Gatta G et al (2013) Methodological aspects of estimating rare cancer prevalence in Europe: the experience of the RARECARE project. Cancer Epidemiol 37(6):850–856CrossRefPubMedGoogle Scholar
  22. 22.
    Group. RW. Cancer list. [cited 2018 Sep 30]. Available from http://www.rarecareeu/rarecarenet/indexphp/cancerlist
  23. 23.
    Sprague Martinez L, Freeman ER, Winkfield KM (2017) Perceptions of cancer care and clinical trials in the black community: implications for care coordination between oncology and primary care teams. Oncologist 22(9):1094–1101CrossRefPubMedPubMedCentralGoogle Scholar
  24. 24.
    Almutairi KM, Alonazi WB, Alodhayani AA, Vinluan JM, Moussa M, Al-Ajlan AS et al (2017) Barriers to cancer clinical trial participation among Saudi nationals: a cross-sectional study. J Relig Health 56(2):623–634CrossRefPubMedGoogle Scholar
  25. 25.
    Drilon A, Laetsch TW, Kummar S, Du Bois SG, Lassen UN, Demetri GD et al (2018) Efficacy of larotrectinib in TRK fusion-positive cancers in adults and children. N Engl J Med 378(8):731–739CrossRefPubMedPubMedCentralGoogle Scholar
  26. 26.
    ClinicalTrials.gov. [Internet]. Bethesda MUSNIoHccM. [cited 2018 Sep 30]. Available from: https://clinicaltrialsgov/ct2
  27. 27.
    Cherny NI, Dafni U, Bogaerts J, Latino NJ, Pentheroudakis G, Douillard JY, Tabernero J, Zielinski C, Piccart MJ, de Vries EGE (2017) ESMO-magnitude of clinical benefit scale version 1.1. Ann Oncol 28(10):2340–2366CrossRefPubMedGoogle Scholar
  28. 28.
    AACR Project GENIE: Powering precision medicine through an international consortium. Cancer Discov 2017;7(8):818–31Google Scholar
  29. 29.
    [Internet] S. [citied 2018 Sep 30]. Available from https://www.swog.org/clinical-trials/s1609

Copyright information

© American Association for Cancer Education 2019

Authors and Affiliations

  • Ji Hyun Park
    • 1
    • 2
  • Ji Sung Lee
    • 3
  • HaYeong Koo
    • 3
    • 4
  • Jeong Eun Kim
    • 1
  • Jin-Hee Ahn
    • 1
  • Min-Hee Ryu
    • 1
  • Sook-ryun Park
    • 1
  • Shin-kyo Yoon
    • 1
  • Jae Cheol Lee
    • 1
  • Yong-Sang Hong
    • 1
  • Sun Young Kim
    • 1
  • Kyo-Pyo Kim
    • 1
  • Chang-Hoon Yoo
    • 1
  • Jung Yong Hong
    • 1
  • Jae Lyun Lee
    • 1
  • Kyung Hae Jung
    • 1
  • Baek-Yeol Rhyoo
    • 1
  • Tae Won Kim
    • 1
    Email author
  1. 1.Departments of Oncology, Asan Medical CenterUniversity of Ulsan College of MedicineSeoulSouth Korea
  2. 2.Department of Hemato-oncology, Konkuk Medical CenterUniversity of Konkuk College of MedicineSeoulSouth Korea
  3. 3.Clinical Research Center, Asan Institute of Life SciencesAsan Medical CenterSeoulSouth Korea
  4. 4.Korea Clinical Trials Global InitiativeSeoulSouth Korea

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