Prospective evaluation of two recruitment strategies for a randomized controlled cancer prevention trial

Abstract

Purpose To evaluate two recruitment strategies used during the full-scale randomized, placebo-controlled Selenium and Vitamin E Cancer Prevention Trial (SELECT) at one clinical center.

Background Recruitment of participants to cancer prevention trials is challenging and costly and more efficient methods are needed.

Methods SELECT participants were males ≥60 years old who were solicited with two recruitment strategies. In the control strategy, potential participants, identified through purchased mailing lists, were sent a SELECT invitation letter. In the ‘spouse’ strategy, letters were sent to married postmenopausal women already participating in the Women’s Health Initiative (WHI) at our clinical center asking them to provide an enclosed SELECT invitation letter (identical to the one in the control strategy) to the ‘man in her life’. Our hypothesis was that SELECT recruitment of men would be enhanced by this indirect mailing to their spouses already participating in a similar program.

Results In the control strategy, 183,315 invitation letters were mailed to 60,000 men; cumulative response was 2.16%; 600 men ultimately enrolled in SELECT (15.1% of respondents) for a mailing recruitment cost of $259 per participant. In the spouse strategy, 800 women participating in WHI clinical studies had husbands; of the 2214 invitation letters mailed to this group of women, cumulative response was 2.75%; 34 men ultimately enrolled in SELECT (55.7% of respondents) for a mailing recruitment cost of $59 per participant.

Limitation Process information on how invitation letters were handled in the spouse strategy was not collected.

Conclusion A direct mail recruitment strategy was successful in recruiting men to a cancer prevention trial. A recruitment strategy involving indirect mailing to married women participating in a similar research program in the same center did not increase initial response substantially, but a higher proportion of respondents ultimately entered the prevention trial.

Get full access to this article

View all access options for this article.

References

de Salis I. , Tomlin Z. , Toerien M. , Donovan J. Qualitative research to improve RCT recruitment: issues arising in establishing research collaborations. Contemp Clin Trials 2008; 29: 663-70.

Biesecker BB , Ishibe N. , Hadley DW , et al. Psychosocial factors predicting BRCA1/BRCA2 testing decisions in members of hereditary breast and ovarian cancer families . Am J Med Genet 2000; 93: 257-63.

Lewis FM , Deal L. Balancing our lives: A study of the married couple’s experience with breast cancer recurrence. Oncol Nurs Forum 1995; 22: 943-53.

Sadler GR , Ko CM , Malcarne VL , et al. Costs of recruiting couples to a clinical trial. Contemp Clin Trials 2007; 28: 423-32.

Witte SS , El- Bassel N. , Gilbert L. , et al. Recruitment of minority women and their main sexual partners in an HIV/STI prevention trial. J Womens Health ( Larchmt) 2004; 13: 1137-47.

Ridda I. , MacIntyre CR , Lindley RI , Tan CI Difficulties in recruiting older people in clinical trials: An examination of barriers and solutions. Vaccine 2010; 28: 901-06.

Hays J. , Hunt JR , Hubbell FA , et al. The Women’s Health Initiative recruitment methods and results. Ann Epidemiol 2003; 13: S18-77.

Fouad MN , Corbie-Smith G. , Curb D. , et al. Special populations recruitment for the Women’s Health Initiative: successes and limitations. Control Clin Trials 2004; 25: 335-52.

The Women’s Health Initiative Study Group. Design of the Women’s Health Initiative clinical trial and observational study. Control Clin Trials 1998; 19: 61-109.

10.

Chlebowski RT , Hendrix SL , Langer RD , et al. For the WHI Investigators. Estrogen plus progestin influence on breast cancer and mammography in healthy postmenopausal women: The Women’s Health Initiative randomized trial. JAMA 2003; 289: 3243-53.

11.

Chlebowski RT , Wactawski-Wende JM , Hubbell A. , et al. Estrogen plus progestin and colorectal cancer in postmenopausal women. N Engl J Med 2004; 350: 991-1004.

12.

Chlebowski RT , Kuller L. , Prentice RL , et al. Breast cancer after estrogen plus progestin use in postmenopausal women. N Engl J Med 2009; 360: 573-87.

13.

Klein EA , Thopson IM , Lippman SM , et al. SELECT: the selenium and vitamin E cancer prevention trial. J Urology 2001; 166: 1311-15.

14.

Lippman SM , Goodman PJ , Klein EA , et al. Designing the Selenium and Vitamin E Cancer Prevention Trial (SELECT). J Natl Cancer Inst 2005; 97: 94-102.

15.

Lippman SM , Klein EA , Goodman PJ , et al. Effect of selenium and vitamin D on risk of prostate cancer and other cancers. JAMA 2009; 301: 39-51.

16.

Gren L. , Broski K. , Childs J. , et al. Recruitment methods employed in the prostate, lung, colorectal, and ovarian cancer screening trial. Clin Trials 2009; 6: 52-59.

17.

Rubin RR , Fujimoto WY , Marrero DG , et al. Diabetes Prevention Program Research Group. The Diabetes Prevention Program: recruitment methods and results. Control Clin Trials 2002; 23: 157-71.

18.

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

19.

Garrett SKM , Thomas AP , Cicuttini F. , et al. Community based recruitment strategies for a longitudinal interventional study: the VECAT experience. J Clin Epidemiol 2000; 53: 541-48.

20.

Hinshaw LB , Jackson SA , Chen MY Direct mailing was a successful recruitment strategy for a lung-cancer screening trial. J Clin Epidemiol 2007; 60: 853-57.

21.

Cohort Consortium. Available at: http://epi.grants.gov/Consortia.cohort.html (accessed 28 July 2010).