Barriers to Clinical Trial Participation as Perceived by Oncologists and Patients

Authors:
Neal J. Meropol From the Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia; Temple University Hospital, Philadelphia; and Delaware County Regional Cancer Center, Drexel Hill, Pennsylvania.
From the Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia; Temple University Hospital, Philadelphia; and Delaware County Regional Cancer Center, Drexel Hill, Pennsylvania.

Search for other papers by Neal J. Meropol in
Current site
Google Scholar
PubMed Close
 MD
,
Joanne S. Buzaglo From the Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia; Temple University Hospital, Philadelphia; and Delaware County Regional Cancer Center, Drexel Hill, Pennsylvania.

Search for other papers by Joanne S. Buzaglo in
Current site
Google Scholar
PubMed Close
 PhD
,
Jennifer Millard From the Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia; Temple University Hospital, Philadelphia; and Delaware County Regional Cancer Center, Drexel Hill, Pennsylvania.

Search for other papers by Jennifer Millard in
Current site
Google Scholar
PubMed Close
 BS
,
Nevena Damjanov From the Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia; Temple University Hospital, Philadelphia; and Delaware County Regional Cancer Center, Drexel Hill, Pennsylvania.
From the Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia; Temple University Hospital, Philadelphia; and Delaware County Regional Cancer Center, Drexel Hill, Pennsylvania.

Search for other papers by Nevena Damjanov in
Current site
Google Scholar
PubMed Close
 MD
,
Suzanne M. Miller From the Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia; Temple University Hospital, Philadelphia; and Delaware County Regional Cancer Center, Drexel Hill, Pennsylvania.

Search for other papers by Suzanne M. Miller in
Current site
Google Scholar
PubMed Close
 PhD
,
Caroline Ridgway From the Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia; Temple University Hospital, Philadelphia; and Delaware County Regional Cancer Center, Drexel Hill, Pennsylvania.

Search for other papers by Caroline Ridgway in
Current site
Google Scholar
PubMed Close
 BA
,
Eric A. Ross From the Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia; Temple University Hospital, Philadelphia; and Delaware County Regional Cancer Center, Drexel Hill, Pennsylvania.

Search for other papers by Eric A. Ross in
Current site
Google Scholar
PubMed Close
 PhD
,
John D. Sprandio From the Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia; Temple University Hospital, Philadelphia; and Delaware County Regional Cancer Center, Drexel Hill, Pennsylvania.

Search for other papers by John D. Sprandio in
Current site
Google Scholar
PubMed Close
 MD
, and
Perry Watts From the Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia; Temple University Hospital, Philadelphia; and Delaware County Regional Cancer Center, Drexel Hill, Pennsylvania.

Search for other papers by Perry Watts in
Current site
Google Scholar
PubMed Close
 MS
Volume/Issue:
Volume 5: Issue 8
Online Publication Date:
Sep 2007
DOI:
https://doi.org/10.6004/jnccn.2007.0067
Full access

Although clinical trial research is required for the development of improved treatment strategies, very few cancer patients participate in these studies. The purpose of this study was to describe psychosocial barriers to clinical trial participation among oncologists and their cancer patients. A survey was distributed to all medical oncologists in Pennsylvania and a subset of their patients. Relevant background information and assessment of practical and psychosocial barriers to clinical trial participation were assessed. Among 137 oncologists and 170 patients who completed the surveys, 84% of patients were aware of clinical trials, and oncologists and patients generally agreed that clinical trials are important to improving cancer treatment. However, oncologists and patients were more likely to consider clinical trials in advanced or refractory disease. When considering 7 potential barriers to clinical trials, random assignment and fear of receiving a placebo were ranked highly by both patients and oncologists. Patients identified fear of side effects as the greatest barrier to clinical trial participation, whereas oncologists ranked this psychosocial barrier as least important to their patients. Overall, the study found that although oncologists and patients are aware of clinical trials and have favorable attitudes toward them, psychosocial barriers exist for patients that may impact participation in clinical trials. Furthermore, important discrepancies exist between the perceptions of oncologists and those of patients regarding what the psychosocial barriers are. We concluded that characterizing oncologist and patient perceived barriers can help improve communication and decision making about clinical trials, such that participation may be optimized.

Correspondence: Neal J. Meropol, MD, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA 19111. E-mail: Neal.Meropol@fccc.edu
  • Collapse
  • Expand
Print ISSN:
1540-1405
Online ISSN:
1540-1413
Publisher:
National Comprehensive Cancer Network
Cover Journal of the National Comprehensive Cancer Network
  • 1.

    NCCN Clinical Practice Guidelines in Oncology. Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp?button=I+Agree. Accessed August 16, 2007.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 2.

    Klabunde CN, Springer BC, Butler B et al.. Factors influencing enrollment in clinical trials for cancer treatment. South Med J 1999;92:1189–1193.

  • 3.

    Friedman MA, Cain DF. National Cancer Institute sponsored cooperative clinical trials. Cancer 1990;65(10 Suppl):2376–2382.

  • 4.

    Go RS, Frisby KA, Lee JA et al.. Clinical trial accrual among new cancer patients at a community-based cancer center. Cancer 2006;106:426–433.

  • 5.

    Lara PN Jr, Higdon R, Lim N et al.. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol 2001;19:1728–1733.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 6.

    Sung NS, Crowley WF Jr, Genel M et al.. Central challenges facing the national clinical research enterprise. JAMA 2003;289:1278–1287.

  • 7.

    Goldman DP, Schoenbaum ML, Potosky AL et al.. Measuring the incremental cost of clinical cancer research. J Clin Oncol 2001;19:105–110.

  • 8.

    Siminoff LA, Zhang A, Colabianchi N et al.. Factors that predict the referral of breast cancer patients onto clinical trials by their surgeons and medical oncologists. J Clin Oncol 2000;18:1203–1211.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 9.

    Lara PN Jr, Paterniti DA, Chiechi C et al.. Evaluation of factors affecting awareness of and willingness to participate in cancer clinical trials. J Clin Oncol 2005;23:9282–9289.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 10.

    Comis RL, Miller JD, Aldige CR et al.. Public attitudes toward participation in cancer clinical trials. J Clin Oncol 2003;21:830–835.

  • 11.

    Ellis PM, Butow PN, Tattersall MH et al.. Randomized clinical trials in oncology: understanding and attitudes predict willingness to participate. J Clin Oncol 2001;19:3554–3561.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 12.

    Mischel W, Shoda Y. A cognitive-affective system theory of personality: reconceptualizing situations, dispositions, dynamics, and invariance in personality structure. Psychol Rev 1995;102:246–268.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 13.

    Miller SM, Rodoletz M, Mangan CE et al.. Applications of the monitoring process model to coping with severe long-term medical threats. Health Psychol 1996;15:216–225.

  • 14.

    Merz JF, Fischhoff B. Informed consent does not mean rational consent. Cognitive limitations on decision-making. J Leg Med 1990;11:321–350.

  • 15.

    Kahnemann D, Snell J. Predicting utility. In: Hogarth RM, ed. Insights in Decision Making. Chicago: University of Chicago Press; 1990:295–310.

  • 16.

    Shafir E, Tversky A. Thinking through uncertainty: nonconsequential reasoning and choice. Cognit Psychol 1992;24:449–474.

  • 17.

    Miller SM, Shoda Y, Hurley K. Applying cognitive-social theory to health-protective behavior: breast self-examination in cancer screening. Psychol Bull 1996;119:70–94.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 18.

    Miller SM. Monitoring versus blunting styles of coping with cancer influence the information patients want and need about their disease. Implications for cancer screening and management. Cancer 1995;76:167–177.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 19.

    Miller SM, Fang CY, Manne SL et al.. Decision making about prophylactic oophorectomy among at-risk women: psychological influences implications. Gynecol Oncol 1999;75:406–412.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 20.

    Miller SM, Fleisher L, Roussi P et al.. Facilitating informed decision making about breast cancer risk and genetic counseling among women calling the NCI's Cancer Information Service. J Health Commun 2005;10(Suppl):S119–136.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 21.

    Ellis PM. Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature. Ann Oncol 2000;11:939–945.

  • 22.

    Ross S, Grant A, Counsell C et al.. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol 1999;52:1143–1156.

  • 23.

    Miller SM, Diefenbach M. C-SHIP: a cognitive-social health information processing approach to cancer. In: Krantz D, ed. Perspectives in Behavioral Medicine. Mahwah: Lawrence Erlbaum; 1998:219–244.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 24.

    Meropol NJ, Weinfurt KP, Burnett CB et al.. Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication. J Clin Oncol 2003;21:2589–2596.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 25.

    Daugherty C, Ratain MJ, Grochowski E et al.. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 1995;13:1062–1072.

  • 26.

    Cheng JD, Hitt J, Koczwara B et al.. Impact of quality of life on patient expectations regarding phase I clinical trials. J Clin Oncol 2000;18:421–428.

  • 27.

    Horstmann E, McCabe MS, Grochow L et al.. Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med 2005;352:895–904.

  • 28.

    Kreuter MW, Lukwago SN, Bucholtz RD et al.. Achieving cultural appropriateness in health promotion programs: targeted and tailored approaches. Health Educ Behav 2003;30:133–146.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 29.

    Kreuter MW, Steger-May K, Bobra S et al.. Sociocultural characteristics and responses to cancer education materials among African American women. Cancer Control 2003;10(5 Suppl):69–80.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 30.

    Lukwago SN, Kreuter MW, Holt CL et al.. Sociocultural correlates of breast cancer knowledge and screening in urban African American women. Am J Public Health 2003;93:1271–1274.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 31.

    Miller SM, Bowen DJ, Campbell MK et al.. Current research promises and challenges in behavioral oncology: report from the American Society of Preventive Oncology Annual Meeting, 2002. Cancer Epidemiol Biomarkers Prev 2004;13:171–180.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 32.

    Miller SM, Siejak KK, Schroeder CM et al.. Enhancing adherence following abnormal pap smears among low-income minority women: a preventive telephone counseling strategy. J Natl Cancer Inst 1997;89:703–708.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 33.

    Martel CL, Li Y, Beckett L et al.. An evaluation of barriers to accrual in the era of legislation requiring insurance coverage of cancer clinical trial costs in California. Cancer J 2004;10:294–300.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 34.

    Sateren WB, Trimble EL, Abrams J et al.. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol 2002;20:2109–2117.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 35.

    Guarino MJ, Masters GA, Schneider CJ et al.. Barriers exist to patient participation in clinical trials. J Clin Oncol 2005;23(Suppl 16):6015.

  • 36.

    National Center for Policy Analysis. Crisis of the Uninsured: 2006 Update. No. 568: September 6, 2006. Available at: http://www.ncpa.org/pub/ba/ba568/. Accessed August 16, 2007.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 37.

    AARP Public Policy Institute. State Profiles—Pennsylvania: Reforming the Health Care System. December 2005, 13th ed. Available at: http://www.aarp.org/research/health/carefinancing/reform_profiles.html. Accessed August 16, 2007.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 38.

    U.S. Census Bureau: State and County QuickFacts. Data derived from Population Estimates, 2000 Census of Population and Housing, 1990 Census of Population and Housing, Small Area Income and Poverty Estimates, County Business Patterns, 1997 Economic Census, Minority- and Women-Owned Business, Building Permits, Consolidated Federal Funds Report, 1997 Census of Governments [Internet]. 02/2005. Available at: http://quickfacts.census.gov/qfd/states/42000.html. Accessed August 16, 2007.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 39.

    Pennsylvania Department of Health. EpiQMS. Available at: http://app2.health.state.pa.us/epiqms. Accessed November 3, 2006.

  • 40.

    Commonwealth of Pennsylvania, Department of Health, Bureau of Health Statistics and Research. Number of cancer case by county, age, sex and race, by 23 primary sites. Pennsylvania residents 2003. Available at: http://www.dsf.health.state.pa.us/health?a=175&q=230674. Accessed 11/03/06.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 41.

    Mills EJ, Seely D, Rachlis B et al.. Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol 2006;7:141–148.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 42.

    Melisko ME, Hassin F, Metzroth L et al.. Patient and physician attitudes toward breast cancer clinical trials: developing interventions based on understanding barriers. Clin Breast Cancer 2005;6:45–54.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 43.

    Coyne CA, Demian-Popescu C, Brown P. Rural cancer patients' perspectives on clinical trials: a qualitative study. J Cancer Educ 2004;19:165–169.

  • 44.

    Llewellyn-Thomas HA, McGreal MJ, Thiel EC et al.. Patients' willingness to enter clinical trials: measuring the association with perceived benefit and preference for decision participation. Soc Sci Med 1991;32:35–42.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 45.

    Eng M, Taylor L, Verhoef M et al.. Understanding participation in a trial comparing cryotherapy and radiation treatment. Can J Urol 2005;12:2607–2613.

  • 46.

    Meropol NJ. Meropol, NJ: Health Services Research Poster Discussion Session: 2005 ASCO Annual Meeting. Orlando, FL. May 16, 2005. Available at: http://www.asco.org/ac/1,1003,_12-002514-00_18-0034-00_19-00706-00_21-0030,00.asp. Accessed December 16, 2005.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 47.

    Engelman KK, Perpich DL, Peterson SL et al.. Cancer information needs in rural areas. J Health Commun 2005;10:199–208.

  • 48.

    Liang W, Burnett CB, Rowland JH et al.. Communication between physicians and older women with localized breast cancer: implications for treatment and patient satisfaction. J Clin Oncol 2002;20:1008–1016.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 49.

    Fallowfield L, Jenkins V. Effective communication skills are the key to good cancer care. Eur J Cancer 1999;35:1592–1597.

  • 50.

    Fallowfield L, Jenkins V, Farewell V, Solis-Trapala I. Enduring impact of communication skills training: results of a 12-month follow-up. Br J Cancer 2003;89:1445–1449.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 51.

    Sepucha KR, Belkora JK, Tripathy D, Esserman LJ. Building bridges between physicians and patients: results of a pilot study examining new tools for collaborative decision making in breast cancer. J Clin Oncol 2000;18:1230–1238.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 52.

    Albrecht TL, Blanchard C, Ruckdeschel JC et al.. Strategic physician communication and oncology clinical trials. J Clin Oncol 1999;17:3324–3332.

  • 53.

    Jenkins V, Fallowfield L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer 2000;82:1783–1788.

  • 54.

    Ruckdeschel JC, Albrecht TL, Blanchard C, Hemmick RM. Communication, accrual to clinical trials, and the physician-patient relationship: implications for training programs. J Cancer Educ 1996;11:73–79.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 55.

    Jenkins V, Fallowfield L, Solis-Trapala I et al.. Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programme. BMJ 2005;330:400.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 56.

    Cegala DJ, McClure L, Marinelli TM, Post DM. The effects of communication skills training on patients' participation during medical interviews. Patient Educ Couns 2000;41:209–222.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 57.

    Cegala DJ, Post DM, McClure L. The effects of patient communication skills training on the discourse of older patients during a primary care interview. J Am Geriatr Soc 2001;49:1505–1511.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 58.

    Robinson EJ, Whitfield MJ. Improving the efficiency of patients' comprehension monitoring: a way of increasing patients' participation in general practice consultations. Soc Sci Med 1985;21:915–919.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 59.

    Roter DL. Patient participation in the patient-provider interaction: the effects of patient question asking on the quality of interaction, satisfaction and compliance. Health Educ Monogr 1977;5:281–315.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 60.

    Thompson SC, Nanni C, Schwankovsky L. Patient-oriented interventions to improve communication in a medical office visit. Health Psychol 1990;9:390–404.

  • 61.

    Cegala DJ, Marinelli T, Post D. The effects of patient communication skills training on compliance. Arch Fam Med 2000;9:57–64.

  • 62.

    Greenfield S, Kaplan S, Ware JE Jr. Expanding patient involvement in care. Effects on patient outcomes. Ann Intern Med 1985;102:520–528.

  • 63.

    Greenfield S, Kaplan SH, Ware JE Jr et al.. Patients' participation in medical care: effects on blood sugar control and quality of life in diabetes. J Gen Intern Med 1988;3:448–457.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 64.

    Kaplan SH, Greenfield S, Ware JE Jr. Assessing the effects of physician-patient interactions on the outcomes of chronic disease. Med Care 1989;27(3 Suppl):S110–127.

    • PubMed
    • Search Google Scholar
    • Export Citation
Copyright:
Copyright © 2007 by the National Comprehensive Cancer Network
Page Numbers:
10
Article Category:
Research Article
Received:
13 Jun 2006
Accepted:
05 Mar 2007
Print Publication Date:
01 Sep 2007
Online Publication Date:
Sep 2007
Keywords:
Barriers to clinical trials; health services research; psychology; psychosocial factors; doctor–patient communication; cancer

Metrics

All Time Past Year Past 30 Days
Abstract Views 0 0 0
Full Text Views 3855 1147 161
PDF Downloads 2259 460 31
EPUB Downloads 0 0 0