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Recruitment Strategies for Cancer Prevention Trials

  • Chapter
Cancer Chemoprevention

Part of the book series: Cancer Drug Discovery and Development ((CDD&D))

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Abstract

A prevention trial based on solid preclinical or clinical data may fail without a well-thought-out strategy for recruitment, retention of subjects, and sufficient expenditure of resources. Ruffin and Baron (1) point out that less than 10% of subjects identified as eligible for the trials are ultimately recruited. Since prevention trial subjects are well, they may feel that they have little to gain by participating. Concerns over waiting, travel time, costs, and fear of randomization are some of the barriers to recruitment. In addition, failure to recognize the importance of health care providers in recruitment and overly complex trial designs may also delay or inhibit accrual goals. In studies involving hereditary high-risk subjects, participants may not wish to enroll because of fear of loss of employment or loss of insurability.

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References

  1. Ruffin MT, Baron J. Recruiting subjects in cancer prevention and control studies. J Cell Biochem Suppl 2000;34:80–83.

    Article  PubMed  Google Scholar 

  2. Lovato LC, Hill K, Hertert S, et al. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials 1997;18:328–352.

    Article  PubMed  CAS  Google Scholar 

  3. Rimer BK. Participant enrollment, participation, and compliance in chemoprevention trials. Adv Exp Med Biol 1992;320:111–117.

    PubMed  CAS  Google Scholar 

  4. Prout TE. Patient recruitment techniques in clinical trials. Control Clin Trials 1981;1: 313–318.

    Article  PubMed  CAS  Google Scholar 

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

    PubMed  CAS  Google Scholar 

  6. Tilley BC, Peterson EL, Kleerekoper M, et al. Designing clinical trials of treatment for osteoporosis: recruitment and follow-up. Calcif Tissue Int 1990;47:327–331.

    Article  PubMed  CAS  Google Scholar 

  7. Trauth JM, Musa D, Siminoff L, et al. Public attitudes regarding willingness to participate in medical research studies. J Health Soc Policy 2000;12:23–43.

    Article  PubMed  CAS  Google Scholar 

  8. Hudmon KS, Stoltzfus C, Chamberlain RM, et al. Participants’ perceptions of a Phase I colon cancer chemoprevention trial. Control Clin Trials 1996;17:494–508.

    Article  PubMed  CAS  Google Scholar 

  9. Tangrea JA, Adrianza ME, Helsel WE. Patients’ perceptions on participation in a cancer chemoprevention trial. Cancer Epidemiol Biomarkers Prev 1992;1:325–330.

    CAS  Google Scholar 

  10. Arnold A, Johnstone B, Stoskopf B, et al. Recruitment for an efficacy study in chemoprevention—the concerned smoker study. Prev Med 1989;18:700–710.

    Article  PubMed  CAS  Google Scholar 

  11. Tangrea JA. Patient participation and compliance in cancer chemoprevention trials: issues and concerns. Proc Soc Exp Biol Med 1997;216:260–265.

    PubMed  CAS  Google Scholar 

  12. Britton A, McKee M, Black N, et al. Threats to applicability of randomised trials: exclusions and selective participation. J Health Serv Res Policy 1999;4:112–121.

    PubMed  CAS  Google Scholar 

  13. King AC, Harris RB, Haskell WL. Effect of recruitment strategy on types of subjects entered into a primary prevention clinical trial. Ann Epidemiol 1994;4:312–320.

    Article  PubMed  CAS  Google Scholar 

  14. Rudick C, Anthonisen NR, Manfreda J. Recruiting healthy participants for a large clinical trial. Control Clin Trials 1993;14:68S–79S.

    Article  PubMed  CAS  Google Scholar 

  15. Boles M, Getchell WS, Feldman G, et al. Primary prevention studies and the healthy elderly: evaluating barriers to recruitment. J Community Health 2000;25:279–292.

    Article  PubMed  CAS  Google Scholar 

  16. Kaakko T, Murtomaa H, Milgrom P, et al. Recruiting phobic research subjects: effectiveness and cost. Anesth Prog 2001;48:3–8.

    PubMed  CAS  Google Scholar 

  17. Kinney AY, Richards C, Vernon SW, Vogel VG. The effect of physician recommendation on enrollment in the breast cancer chemoprevention trial. Prev Med 1998;27:713–719.

    Article  PubMed  CAS  Google Scholar 

  18. Wadland WC, Hughes JR, Secker-Walker RH, et al. Recruitment in a primary care trial on smoking cessation. Fam Med 1990;22:201–204.

    PubMed  CAS  Google Scholar 

  19. McBride PE, Massoth KM, Underbakke G, et al. Recruitment of private practices for primary care research: experience in a preventive services clinical trial. J Fam Pract 1996;43:389–395.

    PubMed  CAS  Google Scholar 

  20. Gerace TA, George VA, Arango IG. Response rates to six recruitment mailing formats and two messages about a nutrition program for women 50-79 years old. Control Clin Trials 1995;16:422–431.

    Article  PubMed  CAS  Google Scholar 

  21. Garrett SK, Thomas AP, Cicuttini F, et al. Community-based recruitment strategies for a longitudinal interventional study: the VECAT experience. J Clin Epidemiol 2000;53:541–548.

    Article  PubMed  CAS  Google Scholar 

  22. Daly M, Seay J, Balshem A, et al. Feasibility of a telephone survey to recruit health maintenance organization members into a tamoxifen chemoprevention trial. Cancer Epidemiol Biomarkers Prev 1992;1:413–416.

    PubMed  CAS  Google Scholar 

  23. Silagy CA, Campion K, McNeil JJ, et al. Comparison of recruitment strategies for a large-scale clinical trial in the elderly. J Clin Epidemiol 1991;44:1105–1114.

    Article  PubMed  CAS  Google Scholar 

  24. Newcomb PA, Love RR, Phillips JL, Buckmaster BJ. Using a population-based cancer registry for recruitment in a pilot cancer control study. Prev Med 1990;19:61–65.

    Article  PubMed  CAS  Google Scholar 

  25. Sugarman J, Regan K, Parker B, et al. Ethical ramifications of alternative means of recruiting research participants from cancer registries. Cancer 1999;86:647–651.

    Article  PubMed  CAS  Google Scholar 

  26. Simpson NK, Johnson CC, Ogden SL, et al. Recruitment strategies in the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial: the first six years. Control Clin Trials 2000;21:356S–378S.

    Article  PubMed  CAS  Google Scholar 

  27. Loescher LJ, Graham VE, Aickin M, et al. Development of a contingency recruitment plan for a Phase III chemoprevention trial of cervical dysplasia. Prog Clin Biol Res 1990;339: 151–163.

    PubMed  CAS  Google Scholar 

  28. Thornquist MD, Patrick DL, Omenn GS. Participation and adherence among older men and women recruited to the beta-carotene and retinol efficacy trial (CARET). Gerontologist 1991;31:593–597.

    PubMed  CAS  Google Scholar 

  29. Paskett ED, DeGraffinreid C, Tatum CM, Margitic SE. The recruitment of African-Americans to cancer prevention and control studies. Prev Med 1996;25:547–553.

    Article  PubMed  CAS  Google Scholar 

  30. Roberson NL. Clinical trial participation. Viewpoints from racial/ethnic groups. Cancer 1994;74: 2687–2691.

    Article  PubMed  CAS  Google Scholar 

  31. Mouton CP, Harris S, Rovi S, et al. Barriers to black women’s participation in cancer clinical trials. J Natl Med Assoc 1997;89:721–727.

    PubMed  CAS  Google Scholar 

  32. Zhu K, Hunter S, Bernard LJ, et al. Recruiting elderly African-American women in cancer prevention and control studies: a multifaceted approach and its effectiveness. J Natl Med Assoc 2000;92:169–175.

    PubMed  CAS  Google Scholar 

  33. Fitzgibbon ML, Prewitt TE, Blackman LR, et al. Quantitative assessment of recruitment efforts for prevention trials in two diverse black populations. Prev Med 1998;27:838–845.

    Article  PubMed  CAS  Google Scholar 

  34. Lewis CE, George V, Fouad M, et al. Recruitment strategies in the women’s health trial: feasibility study in minority populations. WHT:FSMP Investigators Group. Control Clin Trials 1998;19:461–476.

    Article  PubMed  CAS  Google Scholar 

  35. Stallings FL, Ford ME, Simpson NK, et al. Black participation in the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial. Control Clin Trials 2000;21:379S–389S.

    Article  PubMed  CAS  Google Scholar 

  36. Outlaw FH, Bourjolly JN, Barg FK. A study on recruitment of black Americans into clinical trials through a cultural competence lens. Cancer Nurs 2000;23:444–451.

    Article  PubMed  CAS  Google Scholar 

  37. Moinpour CM, Lovato LC, Thompson IM Jr, et al. Profile of men randomized to the prostate cancer prevention trial: baseline health-related quality of life, urinary and sexual functioning, and health behaviors. J Clin Oncol 2000;18: 1942–1953.

    PubMed  CAS  Google Scholar 

  38. Moinpour CM, Atkinson JO, Thomas SM, et al. Minority recruitment in the prostate cancer prevention trial. Ann Epidemiol 2000;10:S85–S91.

    Article  PubMed  CAS  Google Scholar 

  39. Holcombe RF, Jacobson J, Li A, Moinpour CM. Inclusion of black Americans in oncology clinical trials: the Louisiana State University Medical Center experience. Am J Clin Oncol 1998;22:18–21.

    Article  Google Scholar 

  40. Brown DR, Fouad MN, Basen-Engquist K, Tortolero-Luna G. Recruitment and retention of minority women in cancer screening, prevention, and treatment trials. Ann Epidemiol 2000;10:S13–S21.

    Article  PubMed  CAS  Google Scholar 

  41. Lerman C, Rimer BK, Daly M, et al. Recruiting high risk women into a breast cancer health promotion trial. Cancer Epidemiol Biomarkers Prev 1994;3:271–276.

    PubMed  CAS  Google Scholar 

  42. McCabe MS, Varricchio CG, Padberg RM. Efforts to recruit the economically disadvantaged to national clinical trials. Semin Oncol Nurs 1994;10:123–129.

    Article  PubMed  CAS  Google Scholar 

  43. Petchers MK, Milligan SE. Access to health care in a black urban elderly population. Gerontologist 1988;28:213–217.

    PubMed  CAS  Google Scholar 

  44. Valanis B, Blank J, Glass A. Mailing strategies and costs of recruiting heavy smokers in CARET, a large chemoprevention trial. Control Clin Trials 1998;19:25–38.

    Article  PubMed  CAS  Google Scholar 

  45. Vogel VG, Parker LS. Ethical issues of chemoprevention clinical trials. Cancer Control 1997;4:142–149.

    PubMed  Google Scholar 

  46. Weed DL. Ethics and chemoprevention research. Semin Oncol 1983;10:355–359.

    PubMed  CAS  Google Scholar 

  47. Tambor ES, Bernhardt BA, Geller G, et al. Should women at increased risk for breast and ovarian cancer be randomized to prophylactic surgery? An ethical and empirical assessment. J Womens Health Gend Based Med 2000; 9:223–233.

    Article  PubMed  CAS  Google Scholar 

  48. Parascandola M. Ethics and breast cancer risk assessment. Ann Epidemiol 2000;10:461.

    Article  PubMed  Google Scholar 

  49. Nyrén O. Chemoprevention trials in cancer research—ethical considerations. Acta Oncol 1998;37:235–239.

    Article  PubMed  Google Scholar 

  50. Guest S. Compensation for subjects of medical research: the moral rights of patients and the power of research ethics committees. J Med Ethics 1997;23:181–185.

    Article  PubMed  CAS  Google Scholar 

  51. Fitzmaurice JM. Anew twist in US health care data standards development: adoption of electronic health care transactions standards for administrative simplification. Int J Med Inform 1998;48:19–28.

    Article  PubMed  CAS  Google Scholar 

  52. Gostin LO. National health information privacy: regulations under the health insurance portability and accountability act. JAMA 2001;285:3015–3021.

    Article  PubMed  CAS  Google Scholar 

  53. Melton LJ III. The threat to medical-records research. N Engl J Med 1997;337:1466–1470.

    Article  PubMed  Google Scholar 

  54. Korn D. Medical information privacy and the conduct of biomedical research. Acad Med 2000;75: 963–968.

    Article  PubMed  CAS  Google Scholar 

  55. Loprinzi CL, Love RR, Therneau TM, Verma AK. Inhibition of human skin ornithine decarboxylase activity by alphadifluoromethylornithine. Cancer Ther Control 1989;1: 75–80.

    Google Scholar 

  56. Love RR, Carbone PP, Verma AK, et al. Randomized Phase I chemoprevention dose-seeking study of alpha-difluoromethylornithine. J Natl Cancer Inst 1993;85:732–737.

    Article  PubMed  CAS  Google Scholar 

  57. Carbone PP, Douglas JA, Larson PO, et al. Phase I chemoprevention study of piroxicam and alpha-difluoromethylornithine. Cancer Epidemiol Biomarkers Prev 1998;7: 907–912.

    PubMed  CAS  Google Scholar 

  58. Love RR, Jacoby R, Newton MA, et al. A randomized, placebo-controlled trial of low-dose alpha-difluoromethylornithine in individuals at risk for colorectal cancer. Cancer Epidemiol Biomarkers Prev 1998;7:989–992.

    PubMed  CAS  Google Scholar 

  59. Messing EM, Love RR, Tutsch KD, et al. Low-dose difluoromethylornithine and polyamine levels in human prostate tissue. J Natl Cancer Inst 1999;91:1416–1417.

    Article  PubMed  CAS  Google Scholar 

  60. Carbone PP, Pirsch JD, Thomas JP, et al. Phase I chemoprevention study of difluoromethylornithine in subjects with organ transplants. Cancer Epidemiol Biomarkers Prev 2001;10:657–661.

    PubMed  CAS  Google Scholar 

  61. Loprinzi CL, Messing EM, O’Fallon JR, et al. Toxicity evaluation of difluoromethylornithine: doses for chemoprevention trials. Cancer Epidemiol Biomarkers Prev 1996;5: 371–374.

    PubMed  CAS  Google Scholar 

  62. Carbone PP. Chemoprevention of skin cancers with DFMO: a controlled, randomized clinical trial (NCI Contract no. U01-CA-77158) (personal communication), 2001.

    Google Scholar 

  63. Carbone PP. Phase III randomized, double-blind study of DFMO vs placebo in low-grade superficial bladder cancer (NCI Contract no. N01-CN-25434-01-Phase C) (personal communication), 2001.

    Google Scholar 

  64. Mansour EG. Barriers to clinical trials. Part III: knowledge and attitudes of health care providers. Cancer 1994;74: 2672–2675.

    Article  PubMed  CAS  Google Scholar 

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Author information

Authors and Affiliations

  1. Department of Medicine, University of Wisconsin Comprehensive Cancer Center and Medical Oncology Section, Madison, WI

    Paul P. Carbone MD & Howard Bailey MD

  2. University of Wisconsin Comprehensive Cancer Center, Madison, WI

    Paul P. Carbone MD, Karen Sielaff BSN, Mary Hamielec BA & Howard Bailey MD

  3. University of Wisconsin Medical School, Madison, WI

    Karen Sielaff BSN & Mary Hamielec BA

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  1. Paul P. Carbone MD
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  2. Karen Sielaff BSN
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  3. Mary Hamielec BA
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  4. Howard Bailey MD
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Editors and Affiliations

  1. Biomedical Imaging Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD

    Gary J. Kelloff MD

  2. Gastrointestinal and Other Cancers Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD

    Ernest T. Hawk MD, MPH

  3. CCS Associates, Mountain View, CA

    Caroline C. Sigman PhD

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© 2005 Humana Press Inc., Totowa, NJ

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Carbone, P.P., Sielaff, K., Hamielec, M., Bailey, H. (2005). Recruitment Strategies for Cancer Prevention Trials. In: Kelloff, G.J., Hawk, E.T., Sigman, C.C. (eds) Cancer Chemoprevention. Cancer Drug Discovery and Development. Humana Press. https://doi.org/10.1007/978-1-59259-768-0_14

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  • DOI: https://doi.org/10.1007/978-1-59259-768-0_14

  • Publisher Name: Humana Press

  • Print ISBN: 978-1-58829-077-9

  • Online ISBN: 978-1-59259-768-0

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