Skip to main content
SpringerLink
Log in

The Problem of Underrepresentation: Black Participants in Lifestyle Trials Among Patients with Prostate Cancer

  • Published:
Journal of Racial and Ethnic Health Disparities Aims and scope Submit manuscript

Abstract

Introduction

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.

Materials and Methods

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.

Results

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).

Conclusions

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. 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.

    Article  CAS  Google Scholar 

  2. 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.

    Article  PubMed  Google Scholar 

  3. 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.

    Article  PubMed  Google Scholar 

  4. 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.

    Article  CAS  PubMed  Google Scholar 

  5. 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.

    Article  CAS  Google Scholar 

  6. 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.

    Article  CAS  PubMed  Google Scholar 

  7. 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.

    Article  PubMed  Google Scholar 

  8. 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.

    Article  PubMed  Google Scholar 

  9. 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.

    Article  PubMed  Google Scholar 

  10. 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.

  11. 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.

    Article  PubMed  Google Scholar 

  12. 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.

    Article  CAS  PubMed  Google Scholar 

  13. 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.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  14. 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.

    Article  CAS  PubMed  Google Scholar 

  15. 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.

    Article  PubMed  PubMed Central  Google Scholar 

  16. 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.

    Article  PubMed  Google Scholar 

  17. 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.

    Article  CAS  PubMed  Google Scholar 

  18. 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.

    Article  PubMed  Google Scholar 

  19. ClinicalTrialsgov: Glossary of Common Site Terms available at https://clinicaltrialsgov/ct2/about-studies/glossary Accessed March 1, 2019.

  20. 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.

    Article  PubMed  Google Scholar 

  21. 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.

    Article  PubMed  Google Scholar 

  22. 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.

    Article  Google Scholar 

  23. 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.

    Article  PubMed  PubMed Central  Google Scholar 

  24. 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.

    Article  PubMed  Google Scholar 

  25. 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.

    Article  PubMed  PubMed Central  Google Scholar 

  26. 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.

    Article  PubMed  PubMed Central  Google Scholar 

  27. 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.

    Article  PubMed  Google Scholar 

  28. 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.

    Article  PubMed  Google Scholar 

  29. 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.

    Article  PubMed  Google Scholar 

  30. 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.

    Article  CAS  PubMed  Google Scholar 

  31. 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.

    Article  Google Scholar 

Download references

Acknowledgments

The investigators would like to thank Karen Basen-Engquist, Janet Cowan, Wendy Demark-Wahnefried, Mark Magbanua, Richard Sloan, Denise Snyder, and Kerri Winters-Stone for their assistance with the preparation of this article.

Funding

This work was funded in part by the National Center for Complementary and Integrative Health (T32AT003997), the National Cancer Institute (R01CA207749, R21CA184605, R01CA181802, K07CA197077), the UCSF Integrative Cancer Pilot Award, the Steven & Christine Burd-Safeway Distinguished Professorship, and the Helen Diller Family Chair in Population Science for Urologic Cancer.

Author information

Author notes

  1. Hala Borno and Stacey A. Kenfield contributed equally as principal investigators.

Authors and Affiliations

  1. UCSF Osher Center for Integrative Medicine, University of California, San Francisco, UCSF Box 1726, 1545 Divisadero Street, Suite 301, San Francisco, CA, 94143, USA

    Kyle B. Zuniga

  2. College of Physicians and Surgeons, Columbia University Medical Center, 630 W 168th Street, New York, NY, 10032, USA

    Kyle B. Zuniga

  3. Division of Hematology and Medical Oncology, University of California, San Francisco, San Francisco, CA, USA

    Hala Borno, Terence W. Friedlander & Li Zhang

  4. Department of Urology, University of California, San Francisco, San Francisco, CA, USA

    June M. Chan, Erin L. Van Blarigan & Stacey A. Kenfield

  5. Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA

    June M. Chan, Erin L. Van Blarigan & Li Zhang

  6. Division of Hematology-Oncology, San Francisco VA Health Care System, San Francisco, CA, USA

    Sunny Wang

Authors
  1. Kyle B. Zuniga
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Hala Borno
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. June M. Chan
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Erin L. Van Blarigan
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Terence W. Friedlander
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Sunny Wang
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Li Zhang
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Stacey A. Kenfield
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kyle B. Zuniga.

Ethics declarations

Conflict of Interest

Kyle B Zuniga has no conflicts of interest to disclose. Hala Borno has a family member with employment, leadership, and stock and other ownership interests in Collective Health. June M Chan has a family member with employment; travel, accommodation, and expense payments; stock and other ownership interests; and research funding from GRAIL; a family member with employment; travel, accommodation, and expense payments; and research funding from Myriad Genetics; institutional affiliation that has research funding from Genomic Health; and research funding from GenomeDx. Erin L Van Blarigan has no conflicts of interest to disclose. Terrence Friedlander has a consulting/advisory role in Genentech; a consulting/advisory role in AstraZeneca; a consulting/advisory role and travel, accommodations, and expense payments in Clovis Oncology; a consulting/advisory role in Foundation Medicine; a leadership role in Med BioGene; a speakers’ bureau role in Sanofi; a speakers’ bureau role in Dendreon; a speakers’ bureau role in Astellas Medivation; travel, accommodations, and expenses payments in AstraZeneca/MedImmune; travel, accommodations, and expenses payments in Genentech/Roche; honoraria in EMD Soreno; research funding from Janssen; research funding from ImClone Systems; research funding from Aragon Pharmaceuticals; and research funding from GlaxoSmithKline. Sunny Wang has institutional affiliation that has research funding from Clovis Oncology. Li Zhang has no conflicts of interest to disclose. Stacey A Kenfield has research funding from GenomeDx and has a consulting/advisory role at Mojo Enterprises, Inc.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee of the University of California, San Francisco and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was deemed unnecessary as de-identified data was gathered retrospectively from publicly available sources or in aggregate from corresponding authors.

Data Availability

The datasets generated during and analyzed during the current study for the reference population are publicly available in the Surveillance, Epidemiology, and End Results (SEER) repository, https://seer.cancer.gov/seerstat/. The datasets generated and analyzed during the current study for the study population were obtained from trial publications, ClinicalTrials.gov, and corresponding author request, and aggregate data can be found in Online Resource 2.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

ESM 1

(DOCX 18.3 kb)

ESM 2

(DOCX 72.1 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Zuniga, K.B., Borno, H., Chan, J.M. et al. The Problem of Underrepresentation: Black Participants in Lifestyle Trials Among Patients with Prostate Cancer. J. Racial and Ethnic Health Disparities 7, 996–1002 (2020). https://doi.org/10.1007/s40615-020-00724-8

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40615-020-00724-8

Keywords

Search

Navigation