Development of a Plain Language Decision Support Tool for Cancer Clinical Trials: Blending Health Literacy, Academic Research, and Minority Patient Perspectives

  • Aisha T. LangfordEmail author
  • Sarah T. Hawley
  • Sue Stableford
  • Jamie L. Studts
  • Margaret M. Byrne


Despite the promise of clinical trials for improving cancer care, less than 5% of all cancer patients participate. Racial/ethnic minorities continue to be underrepresented in cancer clinical trials (CCTs). To address this gap, we developed a plain language, web-based decision support tool (CHOICES DST) in English and Spanish to support decision-making about CCTs among Blacks and Hispanics. In phase 1 (information collection), we conducted qualitative interviews with 45 cancer patients, completed a thorough literature review, and reviewed results from a telephone survey of 1100 cancer patients. In phase 2 (content generation), we created the first iteration of the CHOICES DST. In phase 3 (usability testing), we gathered user experience and acceptability data from a small sample of cancer survivors (n = 9). The Knowledge, Empowerment, and Values Clarification (KEV) model of decision-making was developed based on data from phase 1. The KEV model and other phase 1 data allowed us to create the CHOICES DST platform. Usability testing of the CHOICES DST showed highly favorable responses from users, satisfaction with content, ease of navigation, and a desire to use the tool. Qualitative results identified addressable points that would benefit from content and navigation-related alterations. The final version of the CHOICES DST was well received and understood by Black and Hispanic participants, and adheres to the mandates for plain language communication. This research provides preliminary data that CHOICES DST holds promise for improving knowledge of CCTs and potentially improving informed decision-making about participation in trials.


Cancer survivors Hispanic Americans African Americans Decision making Patient participation Comprehension Choice behavior Clinical trials as topic Neoplasms Internet 



The authors would like to thank the following people and organizations for their assistance on this project: Pamela Burnett, President and Founder of the Beautiful Gate; Peggy Rios, Program Director of the Cancer Support Community Greater Miami; Adriana Cora, Executive Vice President of La Liga Contra el Cancer; and Martha Olivera (formerly of La Liga Contra el Cancer).


This research was supported by the National Cancer Institute and the National Institute of Minority Health and Disparities NIMHD (1RC2MD004784).

Compliance with Ethical Standards

Conflict of Interest

The authors declare that they have no competing interests.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. This study was reviewed and approved by the Institutional Review Board at the University of Miami.


  1. 1.
    Murphy SL, Xu J et al (2017) Deaths: Final Data for 2015. Natl Vital Stat Rep 61(4):1–117 (Print)Google Scholar
  2. 2.
    American Cancer Society. Cancer Facts & Figures 2018. Atlanta: American Cancer Society; 2018, Cancer Facts & Figures 2018Google Scholar
  3. 3.
    National Cancer Institute (2016) What Are Clinical Trials? [cited 2018 December 31]; Available from:
  4. 4.
    Institute of Medicine (2010) A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. Washington D.C. . p. 316Google Scholar
  5. 5.
    Chen MS et al (2014) Twenty years post-NIH revitalization act: renewing the case for enhancing minority participation in cancer clinical trials. Cancer 120(0 7):1091–1096CrossRefGoogle Scholar
  6. 6.
    Langford AT, Resnicow K, Dimond EP, Denicoff AM, Germain DS, McCaskill-Stevens W, Enos RA, Carrigan A, Wilkinson K, Go RS (2014) Racial/ethnic differences in clinical trial enrollment, refusal rates, ineligibility, and reasons for decline among patients at sites in the National Cancer Institute’s Community Cancer Centers Program. Cancer 120(6):877–884CrossRefGoogle Scholar
  7. 7.
    Wendler D, Kington R, Madans J, van Wye G, Christ-Schmidt H, Pratt LA, Brawley OW, Gross CP, Emanuel E (2006) Are racial and ethnic minorities less willing to participate in health research? PLoS Med 3(2):e19CrossRefGoogle Scholar
  8. 8.
    Jimenez R, Zhang B, Joffe S, Nilsson M, Rivera L, Mutchler J, Lathan C, Paulk ME, Prigerson HG (2013) Clinical trial participation among ethnic/racial minority and majority patients with advanced cancer: what factors most influence enrollment? J Palliat Med 16(3):256–262CrossRefGoogle Scholar
  9. 9.
    Holmes DR, Major J, Lyonga DE, Alleyne RS, Clayton SM (2012) Increasing minority patient participation in cancer clinical trials using oncology nurse navigation. Am J Surg 203(4):415–422CrossRefGoogle Scholar
  10. 10.
    Ford JG, Howerton MW, Lai GY, Gary TL, Bolen S, Gibbons MC, Tilburt J, Baffi C, Tanpitukpongse TP, Wilson RF, Powe NR, Bass EB (2008) Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer 112(2):228–242CrossRefGoogle Scholar
  11. 11.
    Byrne MM, Tannenbaum SL, Glück S, Hurley J, Antoni M (2014) Participation in cancer clinical trials: why are patients not participating? Med Decis Mak 34(1):116–126CrossRefGoogle Scholar
  12. 12.
    Fisher JA, Kalbaugh CA (2011) Challenging assumptions about minority participation in US clinical research. Am J Public Health 101(12):2217–2222CrossRefGoogle Scholar
  13. 13.
    Albrecht TL, Eggly SS, Gleason MEJ, Harper FWK, Foster TS, Peterson AM, Orom H, Penner LA, Ruckdeschel JC (2008) Influence of clinical communication on patients’ decision making on participation in clinical trials. J Clin Oncol 26(16):2666–2673CrossRefGoogle Scholar
  14. 14.
    Leiter A, Diefenbach MA, Doucette J, Oh WK, Galsky MD (2015) Clinical trial awareness: changes over time and sociodemographic disparities. Clin Trials 12(3):215–223CrossRefGoogle Scholar
  15. 15.
    Langford A, Resnicow K, An L (2010) Clinical trial awareness among racial/ethnic minorities in HINTS 2007: sociodemographic, attitudinal, and knowledge correlates. J Health Commun 15(Suppl 3):92–101CrossRefGoogle Scholar
  16. 16.
    Penberthy L, Brown R, Wilson-Genderson M, Dahman B, Ginder G, Siminoff LA (2012) Barriers to therapeutic clinical trials enrollment: differences between African-American and white cancer patients identified at the time of eligibility assessment. Clin Trials 9(6):788–797CrossRefGoogle Scholar
  17. 17.
    Shaya FT, Gbarayor CM, Huiwen Keri Yang, Agyeman-Duah M, Saunders E (2007) A perspective on African American participation in clinical trials. Contemp Clin Trials 28(2):213–217CrossRefGoogle Scholar
  18. 18.
    Rivers D, August EM, Sehovic I, Lee Green B, Quinn GP (2013) A systematic review of the factors influencing African Americans’ participation in cancer clinical trials. Contemp Clin Trials 35(2):13–32CrossRefGoogle Scholar
  19. 19.
    Ellington M Jr et al (2001) Child health status, neurodevelopmental outcome, and parental satisfaction in a randomized, controlled trial of nitric oxide for persistent pulmonary hypertension of the newborn. Pediatrics 107(6):1351–1356CrossRefGoogle Scholar
  20. 20.
    Lopez A (2009) Barriers to cancer clinical trial enrollment in Latinos. J Clin Oncol 27(15):e17519Google Scholar
  21. 21.
    Quinn GP, McIntyre J, Gonzalez LE, Antonia TM, Antolino P, Wells KJ (2013) Improving awareness of cancer clinical trials among Hispanic patients and families: audience segmentation decisions for a media intervention. J Health Commun 18(9):1131–1147CrossRefGoogle Scholar
  22. 22.
    National Center for Education Statistics (2003) 1992 National Adult Literacy Survey and 2003 National Assessment of Adult Literacy. [cited 2015 July 28]; Available from:
  23. 23.
    Nielsen-Bohlman L, Panzer AM, Kindig DA (2004) Health Literacy: A Prescription to End Confusion, ed. L. Nielsen-Bohlman, A.M. Panzer, and D.A. Kindig. The National Academies PressGoogle Scholar
  24. 24.
    Volk RJ, Linder SK, Lopez-Olivo MA, Kamath GR, Reuland DS, Saraykar SS, Leal VB, Pignone MP (2016) Patient decision aids for colorectal cancer screening: a systematic review and meta-analysis. Am J Prev Med 51(5):779–791CrossRefGoogle Scholar
  25. 25.
    Gillies K et al (2015) Decision aids for people considering taking part in clinical trials. Cochrane Database Syst Rev 11:Cd009736Google Scholar
  26. 26.
    Juraskova I, Butow P, Bonner C, Bell ML, Smith AB, Seccombe M, Boyle F, Reaby L, Cuzick J, Forbes JF (2014) Improving decision making about clinical trial participation - a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial. Br J Cancer 111(1):1–7CrossRefGoogle Scholar
  27. 27.
    Stacey D, et al. (2017) Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev, (4)Google Scholar
  28. 28.
    Stableford S, Mettger W (2007) Plain language: a strategic response to the health literacy challenge. J Public Health Policy 28(1):71–93CrossRefGoogle Scholar
  29. 29. What is Plain Language? [cited 2018 December 31]; Available from:
  30. 30.
    Juraskova I, Butow P, Lopez A, Seccombe M, Coates A, Boyle F, McCarthy N, Reaby L, Forbes JF (2008) Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS). Health Expect 11(3):252–262CrossRefGoogle Scholar
  31. 31.
    Entwistle V (2008) Supporting participation in clinical research: decision aids for trial recruitment? Health Expect 11(3):205–207CrossRefGoogle Scholar
  32. 32.
    Wood CG, Wei SJ, Hampshire MK, Devine PA, Metz JM (2006) The influence of race on the attitudes of radiation oncology patients towards clinical trial enrollment. Am J Clin Oncol 29(6):593–599CrossRefGoogle Scholar
  33. 33.
    McCaskill-Stevens W, Wilson JW, Cook ED, Edwards CL, Gibson RV, McElwain DL, Figueroa-Moseley CD, Paskett ED, Roberson NL, Wickerham DL, Wolmark N (2013) National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene trial: advancing the science of recruitment and breast cancer risk assessment in minority communities. Clin Trials 10(2):280–291CrossRefGoogle Scholar
  34. 34.
    Corbie-Smith G, Thomas SB, Williams MV, Moody-Ayers S (1999) Attitudes and beliefs of African Americans toward participation in medical research. J Gen Intern Med 14(9):537–546CrossRefGoogle Scholar
  35. 35.
    Brooke J (1996) SUS-A quick and dirty usability scale. In: Jordan PW, Thomas B, Weerdmeester BA, McClelland AL (eds) Usability evaluation in industry. Taylor and Francis, London, p 194Google Scholar
  36. 36.
    Wells AA, Zebrack B (2008) Psychosocial barriers contributing to the under-representation of racial/ethnic minorities in cancer clinical trials. Soc Work Health Care 46(2):1–14CrossRefGoogle Scholar
  37. 37.
    Byrne MM, S J., Hawley S, Bauza C, D’Almeida H, Fagerlin A, Glück S, Gonzalez M, Goodman K, Hurley J, Schmitz SL, Stableford S, Vinard A, Whitehead N (2012) A Abstract: Targeted Decision Aid for minority participation in cancer clinical trials: Effect on knowledge, preparedness for decision-making, self-efficacy, and willingness to participate,, in Society for Medical Decision Making 34th Annual MeetingGoogle Scholar
  38. 38.
    Shaffer VA, Zikmund-Fisher BJ (2013) All stories are not alike: a purpose-, content-, and valence-based taxonomy of patient narratives in decision aids. Med Decis Mak 33(1):4–13CrossRefGoogle Scholar
  39. 39.
    Fleisher L, Ruggieri DG, Miller SM, Manne S, Albrecht T, Buzaglo J, Collins MA, Katz M, Kinzy TG, Liu T, Manning C, Charap ES, Millard J, Miller DM, Poole D, Raivitch S, Roach N, Ross EA, Meropol NJ (2014) Application of best practice approaches for designing decision support tools: the preparatory education about clinical trials (PRE-ACT) study. Patient Educ Couns 96(1):63–71CrossRefGoogle Scholar
  40. 40.
    Elwyn G et al (2006) Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. Bmj 333(7565):417–410CrossRefGoogle Scholar
  41. 41.
    Holmes-Rovner M (2007) International Patient Decision Aid Standards (IPDAS): beyond decision aids to usual design of patient education materials. Health Expect 10(2):103–107CrossRefGoogle Scholar
  42. 42.
    McCaffery KJ et al (2013) Addressing health literacy in patient decision aids. BMC Med Inform Decis Mak 13(Suppl 2):S10CrossRefGoogle Scholar
  43. 43.
    Volk RJ et al (2013) Ten years of the international patient decision aid standards collaboration: evolution of the core dimensions for assessing the quality of patient decision aids. BMC Med Inform Decis Mak 13(Suppl 2):S1PubMedPubMedCentralGoogle Scholar

Copyright information

© American Association for Cancer Education 2019

Authors and Affiliations

  1. 1.Department of Population HealthNew York University School of MedicineNew YorkUSA
  2. 2.Ann Arbor VA Center of Excellence in Health Services Research & DevelopmentUniversity of Michigan Departments of Internal Medicine and Health Management & PolicyAnn ArborUSA
  3. 3.Health Literacy, Plain Language, & Clear Health Communication ConsultantBrunswickUSA
  4. 4.Department of Behavioral ScienceUniversity of Kentucky College of MedicineLexingtonUSA
  5. 5.Department of Health Outcomes and BehaviorMoffitt Cancer CenterTampaUSA

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