Skip to main content

Advertisement

SpringerLink
Log in

The impact of sharing results of a randomized breast cancer clinical trial with study participants

  • Clinical Trial
  • Published:
Breast Cancer Research and Treatment Aims and scope Submit manuscript

Abstract

Background There has been growing interest in providing clinical trial participants with study results yet only limited information exists regarding the process and impact of sharing results. We sought to evaluate patient perceptions of how results had been shared from a large randomized cooperative group trial, and the impact of learning results. Patients and methods A subset of women who participated in NCCTG 9831 (A Phase III Trial of Adjuvant Chemotherapy with or without Trastuzumab for Women with HER2-positive Breast Cancer) were mailed surveys after the preliminary study results were released to the public and mailed to participants. Results One hundred and 67 of 228 surveys sent (73%) were returned; 61% reported receiving trastuzumab on study; 4% reported recurrent disease. Ninety-five percent of participants were glad they received results; 81% were satisfied with how results were shared; 23% were more anxious after learning the results. Sixty-nine percent correctly interpreted the results. Logistic regression revealed that satisfaction with the process of receiving results was associated with satisfaction with treatment (P = 0.04), and increased anxiety was associated with dissatisfaction with treatment (0.02), incorrect interpretation of results (0.04), and not having received trastuzumab (P < 0.0001). Conclusion Sharing results directly with study participants is met with overwhelmingly favorable responses from patients, although some may not initially understand the findings. The potential for increased anxiety should be considered, and psychosocial support may be required by some. A plan to share results should be routinely and prospectively considered in the design of cancer clinical 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.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Jemal A, Siegel R, Ward E et al (2007) Cancer statistics, 2007. CA Cancer J Clin 57:43–66

    Article  PubMed  Google Scholar 

  2. Wittes RE, Friedman MA (1988) Accrual to clinical trials. J Natl Cancer Inst 80:884–885. doi:10.1093/jnci/80.12.884

    Article  PubMed  CAS  Google Scholar 

  3. Comis RL, Aldige CR, Stovall EL et al (2000) A quantitative survey of public attitudes towards cancer clinical trials—a Harris Interactive poll. pp 1–10. www.cancersummit.org

  4. Cancer Leadership Counsel Cancer Research Foundation of America, Coalition of National Cancer Cooperative Groups et al. (2000) The summit series on clinical trials website—recommendations and action steps. www.cancersummit.org

  5. Partridge AH, Winer EP (2002) Informing clinical trial participants about study results. JAMA 288:363–365. doi:10.1001/jama.288.3.363

    Article  PubMed  Google Scholar 

  6. Fernandez CV, Kodish E, Weijer C (2003) Informing study participants of research results: an ethical imperative. IRB 25:12–19. doi:10.2307/3564300

    Article  PubMed  Google Scholar 

  7. Shalowitz DI, Miller FG (2005) Disclosing individual results of clinical research: implications of respect for participants. JAMA 294:737–740. doi:10.1001/jama.294.6.737

    Article  PubMed  CAS  Google Scholar 

  8. Shurin S (2001) Bioethics Committee: report and invitation. Child Oncol News 2:14

  9. Coalition of National Cancer Cooperative Groups Inc (2002) Guidelines for notifying patients about early closure of cancer clinical trials. www.cancertrialshelp.org [Last accessed on 12/1/02]

  10. Buchwald H, Fitch LL, Matts JP et al (1993) Perception of quality of life before and after disclosure of trial results: a report from the Program on the Surgical Control of the Hyperlipidemias (POSCH). Control Clin Trials 14:500–510. doi:10.1016/0197-2456(93)90030-H

    Article  PubMed  CAS  Google Scholar 

  11. Snowdon C, Garcia J, Elbourne D (1998) Reactions of participants to the results of a randomised controlled trial: exploratory study. BMJ 317:21–26

    PubMed  CAS  Google Scholar 

  12. Schulz CJ, Riddle MP, Valdimirsdottir HB et al (2003) Impact on survivors of retinoblastoma when informed of study results on risk of second cancers. Med Pediatr Oncol 41:36–43. doi:10.1002/mpo.10278

    Article  PubMed  Google Scholar 

  13. Partridge AH, Wong JS, Knudsen K et al (2005) Offering participants results of a clinical trial: sharing results of a negative study. Lancet 365:963–964. doi:10.1016/S0140-6736(05)71085-0

    Article  PubMed  Google Scholar 

  14. Dixon-Woods M, Jackson C, Windridge KC et al (2006) Receiving a summary of the results of a trial: qualitative study of participants’ views. BMJ 332:206–210. doi:10.1136/bmj.38675.677963.3A

    Article  PubMed  Google Scholar 

  15. Partridge AH, Burstein HJ, Bluman LG et al (2002) Should patients with cancer be offered aggregate results of clinical trials in which they have participated? Proc Am Soc Clin Oncol 21:259a. Abstract 1034

    Google Scholar 

  16. Partridge AH, Hackett N, Blood E et al (2004) Oncology physician and nurse practices and attitudes regarding offering clinical trial results to study participants. J Natl Cancer Inst 96:629–632

    Article  PubMed  Google Scholar 

  17. Markman M (2006) Providing research participants with findings from completed cancer-related clinical trials: not quite as simple as it sounds. Cancer 106:1421–1424. doi:10.1002/cncr.21757

    Article  PubMed  Google Scholar 

  18. Romond EH, Perez EA, Bryant J et al (2005) Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 353:1673–1684. doi:10.1056/NEJMoa052122

    Article  PubMed  CAS  Google Scholar 

  19. Agresti A (2002) Chapter 6, categorical data analysis, 2nd edn. New Jersey, Wiley, pp 211–267

  20. Johnson L, Barrett-Lee P, Ellis P et al (2008) How do patients want to learn of results of clinical trials? A survey of 1431 breast cancer patients. Br J Cancer 98:34–38. doi:10.1038/sj.bjc.6604119

    Article  PubMed  CAS  Google Scholar 

  21. Oddens BJ, Algra A, van Gijn J (1993) Informing patients about clinical trials. Clin Investig 71:572–573. doi:10.1007/BF00208484

    Article  PubMed  CAS  Google Scholar 

  22. Taylor KM, Kelner M (1987) Informed consent: the physician’s perspective. Soc Sci Med 24:135–143. doi:10.1016/0277-9536(87)90246-2

    Article  PubMed  CAS  Google Scholar 

  23. Harris KA (1998) The informational needs of patients with cancer and their families. Cancer Pract 6:39–46. doi:10.1046/j.1523-5394.1998.1998006039.x

    Article  PubMed  CAS  Google Scholar 

  24. Degner LF, Davison BJ, Sloan JA et al (1998) Development of a scale to measure information needs in cancer care. J Nurs Meas 6:137–153

    PubMed  CAS  Google Scholar 

  25. Beaver K, Luker KA, Owens RG et al (1996) Treatment decision making in women newly diagnosed with breast cancer. Cancer Nurs 19:8–19. doi:10.1097/00002820-199602000-00002

    Article  PubMed  CAS  Google Scholar 

  26. Hack TF, Degner LF, Dyck DG (1994) Relationship between preferences for decisional control and illness information among women with breast cancer: a quantitative and qualitative analysis. Soc Sci Med 39:279–289. doi:10.1016/0277-9536(94)90336-0

    Article  PubMed  CAS  Google Scholar 

  27. Degner LF, Russell CA (1988) Preferences for treatment control among adults with cancer. Res Nurs Health 11:367–374. doi:10.1002/nur.4770110604

    Article  PubMed  CAS  Google Scholar 

  28. Fernandez CV, Kodish E, Weijer C (2003) Importance of informed consent in offering to return research results to research participants. Med Pediatr Oncol 41:592–593. doi:10.1002/mpo.10435

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Dana-Farber Cancer Institute, 44 Binney St, Boston, MA, 02115, USA

    Ann H. Partridge, L. Zhang, R. Gelman, E. Sampson & E. P. Winer

  2. The Sidney Kimmel Cancer Center at Johns Hopkins, Baltimore, MD, USA

    A. C. Wolff

  3. Duke University Medical Center, Durham, NC, USA

    P. K. Marcom

  4. Dartmouth Hitchcock Medical Center, Lebanon, NH, USA

    P. A. Kaufman & C. Moore

  5. Memorial Sloan Kettering Cancer Center, New York, NY, USA

    D. Lake

  6. University of Chicago, Chicago, IL, USA

    G. F. Fleming

  7. University of California San Francisco Comprehensive Cancer Center, San Francisco, CA, USA

    H. S. Rugo

  8. Southeastern Medical Oncology Center, Goldsboro, NC, USA

    J. Atkins

  9. Cancer and Leukemia Group B and Patient Advocates in Research, Danville, CA, USA

    D. Collyar

Authors
  1. Ann H. Partridge
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. A. C. Wolff
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. P. K. Marcom
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. P. A. Kaufman
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. L. Zhang
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. R. Gelman
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. C. Moore
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. D. Lake
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. G. F. Fleming
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. H. S. Rugo
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. J. Atkins
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. E. Sampson
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. D. Collyar
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. E. P. Winer
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Ann H. Partridge.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Partridge, A.H., Wolff, A.C., Marcom, P.K. et al. The impact of sharing results of a randomized breast cancer clinical trial with study participants. Breast Cancer Res Treat 115, 123–129 (2009). https://doi.org/10.1007/s10549-008-0057-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10549-008-0057-7

Keywords

Search

Navigation