The Problem of Underrepresentation: Black Participants in Lifestyle Trials Among Patients with Prostate Cancer
Tóm tắt
Healthy lifestyle behaviors are an essential component of prostate cancer survivorship; however, it is unknown whether Black participants are adequately represented in randomized controlled trials (RCTs) on lifestyle interventions. The goal of this study was to identify types of lifestyle RCTs that may require improved recruitment resources to enhance generalizability of lifestyle recommendations to Black patients.
ClinicalTrials.gov
was used to identify lifestyle RCTs among patients with prostate cancer. Using racial distribution data from the Surveillance, Epidemiology, and End Results (SEER) program as a reference, one-sample proportion tests were performed to assess adequate recruitment of Black participants. Of 31 lifestyle trials, one trial reported race-specific results. Proportion of Black participants was acquired from 26 trials. Compared to the US population, Black participants were overrepresented in the overall study population (17% versus 15%, p = 0.019). Black participants were underrepresented in trials exploring exercise interventions (9% versus 15%, p = 0.041), trials among patients with advanced disease (9% versus 16%, p < 0.001), and in university-funded trials (12% versus 15%, p = 0.026). The reporting of race data, and race-specific results when feasible, is essential for clinicians to accurately generalize findings from lifestyle trials. Additional resources may be necessary to aid in strategic recruitment of Black participants for trials on exercise interventions, trials among patients with advanced disease, and in university-funded trials.
Tài liệu tham khảo
Chasan-Taber S, Rimm EB, Stampfer MJ, Spiegelman D, Colditz GA, Giovannucci E, et al. Reproducibility and validity of a self-administered physical activity questionnaire for male health professionals. Epidemiology (Cambridge, Mass). 1996;7(1):81–6.
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017;67(1):7–30. https://doi.org/10.3322/caac.21387.
Parker PM, Rice KR, Sterbis JR, Chen Y, Cullen J, McLeod DG, et al. Prostate cancer in men less than the age of 50: a comparison of race and outcomes. Urology. 2011;78(1):110–5. https://doi.org/10.1016/j.urology.2010.12.046.
Mahal BA, Chen YW, Muralidhar V, Mahal AR, Choueiri TK, Hoffman KE, et al. Racial disparities in prostate cancer outcome among prostate-specific antigen screening eligible populations in the United States. Ann Oncol. 2017;28(5):1098–104. https://doi.org/10.1093/annonc/mdx041.
Hoffman RM, Gilliland FD, Eley JW, Harlan LC, Stephenson RA, Stanford JL, et al. Racial and ethnic differences in advanced-stage prostate cancer: the prostate cancer outcomes study. J Natl Cancer Inst. 2001;93(5):388–95.
Bensen JT, Xu Z, McKeigue PM, Smith GJ, Fontham ETH, Mohler JL, et al. Admixture mapping of prostate cancer in African Americans participating in the North Carolina-Louisiana prostate cancer project (PCaP). Prostate. 2014;74(1):1–9. https://doi.org/10.1002/pros.22722.
Krishna S, Fan Y, Jarosek S, Adejoro O, Chamie K, Konety B. Racial disparities in active surveillance for prostate cancer. J Urol. 2017;197(2):342–9. https://doi.org/10.1016/j.juro.2016.08.104.
Lee DJ, Zhao Z, Huang LC, Koyoma T, Resnick MJ, Penson DF, et al. Racial variation in receipt of quality radiation therapy for prostate cancer. Cancer Causes Control. 2018;29(10):895–9. https://doi.org/10.1007/s10552-018-1065-5.
Ahaghotu C, Tyler R, Sartor O. African American participation in oncology clinical trials--focus on prostate cancer: implications, barriers, and potential solutions. Clin Genitourin Cancer. 2016;14(2):105–16. https://doi.org/10.1016/j.clgc.2015.12.003.
National Institutes of Health; National Cancer Institute; Surveillance, Epidemiology, and End Results Program: Cancer Stat Facts available at https://seercancergov/statfacts/html/prosthtml Accessed April 1, 2019.
Skolarus TA, Wolf AM, Erb NL, Brooks DD, Rivers BM, Underwood W 3rd, et al. American Cancer Society prostate cancer survivorship care guidelines. CA Cancer J Clin. 2014;64(4):225–49. https://doi.org/10.3322/caac.21234.
Peisch SF, Van Blarigan EL, Chan JM, Stampfer MJ, Kenfield SA. Prostate cancer progression and mortality: a review of diet and lifestyle factors. World J Urol. 2017;35(6):867–74. https://doi.org/10.1007/s00345-016-1914-3.
Goode PS, Burgio KL, Johnson TM 2nd, Clay OJ, Roth DL, Markland AD, et al. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA. 2011;305(2):151–9. https://doi.org/10.1001/jama.2010.1972.
Uth J, Hornstrup T, Christensen JF, Christensen KB, Jorgensen NR, Schmidt JF, et al. Efficacy of recreational football on bone health, body composition, and physical functioning in men with prostate cancer undergoing androgen deprivation therapy: 32-week follow-up of the FC prostate randomised controlled trial. Osteoporos Int. 2016;27(4):1507–18. https://doi.org/10.1007/s00198-015-3399-0.
Focht BC, Lucas AR, Grainger E, Simpson C, Fairman CM, Thomas-Ahner JM, et al. Effects of a group-mediated exercise and dietary intervention in the treatment of prostate cancer patients undergoing androgen deprivation therapy: results from the IDEA-P trial. Ann Behav Med. 2018;52(5):412–28. https://doi.org/10.1093/abm/kax002.
Layne TM, Graubard BI, Ma X, Mayne ST, Albanes D. Prostate cancer risk factors in black and white men in the NIH-AARP diet and health study. Prostate Cancer Prostatic Dis. 2019;22(1):91–100. https://doi.org/10.1038/s41391-018-0070-9.
Allott EH, Arab L, Su LJ, Farnan L, Fontham ETH, Mohler JL, et al. Saturated fat intake and prostate cancer aggressiveness: results from the population-based North Carolina-Louisiana prostate cancer project. Prostate Cancer Prostatic Dis. 2016;20:48–54. https://doi.org/10.1038/pcan.2016.39https://www.nature.com/articles/pcan201639#supplementary-information.
Mohanty S, Bilimoria KY. Comparing national cancer registries: the National Cancer Data Base (NCDB) and the surveillance, epidemiology, and end results (SEER) program. J Surg Oncol. 2014;109(7):629–30. https://doi.org/10.1002/jso.23568.
ClinicalTrialsgov: Glossary of Common Site Terms available at https://clinicaltrialsgov/ct2/about-studies/glossary Accessed March 1, 2019.
Ford JG, Howerton MW, Lai GY, Gary TL, Bolen S, Gibbons MC, et al. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer. 2008;112(2):228–42. https://doi.org/10.1002/cncr.23157.
Chen MS Jr, Lara PN, Dang JHT, Paterniti DA, Kelly K. Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual: renewing the case for enhancing minority participation in cancer clinical trials. Cancer. 2014;120 Suppl 7(0 7):1091–6. https://doi.org/10.1002/cncr.28575.
Geller SE, Koch A, Pellettieri B, Carnes M. Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress? J Women's Health (2002). 2011;20(3):315–20. https://doi.org/10.1089/jwh.2010.2469.
Spratt DE, Osborne JR. Disparities in castration-resistant prostate cancer trials. J Clin Oncol. 2015;33(10):1101–3. https://doi.org/10.1200/JCO.2014.58.1751.
Balakrishnan AS, Palmer NR, Fergus KB, Gaither TW, Baradaran N, Ndoye M, et al. Minority recruitment trends in phase III prostate cancer clinical trials (2003 to 2014): progress and critical areas for improvement. J Urol. 2019;201(2):259–67. https://doi.org/10.1016/j.juro.2018.09.029.
Moses KA, Paciorek AT, Penson DF, Carroll PR, Master VA. Impact of ethnicity on primary treatment choice and mortality in men with prostate cancer: data from CaPSURE. J Clin Oncol. 2010;28(6):1069–74. https://doi.org/10.1200/JCO.2009.26.2469.
Dess RT, Hartman HE, Mahal BA, Soni PD, Jackson WC, Cooperberg MR, et al. Association of black race with prostate cancer–specific and other-cause mortality. JAMA Oncol. 2019;5(7):975–83. https://doi.org/10.1001/jamaoncol.2019.0826.
Winters-Stone KM, Lyons KS, Bennett JA, Beer TM. Patterns and predictors of symptom incongruence in older couples coping with prostate cancer. Support Care Cancer. 2014;22(5):1341–8. https://doi.org/10.1007/s00520-013-2092-0.
Winters-Stone KM, Dobek JC, Bennett JA, Dieckmann NF, Maddalozzo GF, Ryan CW, et al. Resistance training reduces disability in prostate cancer survivors on androgen deprivation therapy: evidence from a randomized controlled trial. Arch Phys Med Rehabil. 2015;96(1):7–14. https://doi.org/10.1016/j.apmr.2014.08.010.
Winters-Stone KM, Lyons KS, Dobek J, Dieckmann NF, Bennett JA, Nail L, et al. Benefits of partnered strength training for prostate cancer survivors and spouses: results from a randomized controlled trial of the exercising together project. J Cancer Surviv. 2016;10(4):633–44. https://doi.org/10.1007/s11764-015-0509-0.
Lippman SM, Goodman PJ, Klein EA, Parnes HL, Thompson IM, Kristal AR, et al. Designing the selenium and vitamin E cancer prevention trial (SELECT). JNCI. 2005;97(2):94–102. https://doi.org/10.1093/jnci/dji009.
Heiney SP, Arp Adams S, Drake BF, Bryant LH, Bridges L, Hebert JR. Successful subject recruitment for a prostate cancer behavioral intervention trial. Clin Trials (London, England). 2010;7(4):411–7. https://doi.org/10.1177/1740774510373491.