Breast Cancer Research and Treatment

, Volume 115, Issue 1, pp 123–129

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

  • Ann H. Partridge
  • A. C. Wolff
  • P. K. Marcom
  • P. A. Kaufman
  • L. Zhang
  • R. Gelman
  • C. Moore
  • D. Lake
  • G. F. Fleming
  • H. S. Rugo
  • J. Atkins
  • E. Sampson
  • D. Collyar
  • E. P. Winer
Clinical Trial

DOI: 10.1007/s10549-008-0057-7

Cite this article as:
Partridge, A.H., Wolff, A.C., Marcom, P.K. et al. Breast Cancer Res Treat (2009) 115: 123. doi:10.1007/s10549-008-0057-7

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.

Keywords

Breast cancerClinical trial resultsCancer communicationResearch ethicsAdjuvant trastuzumab

Copyright information

© Springer Science+Business Media, LLC. 2008

Authors and Affiliations

  • Ann H. Partridge
    • 1
  • A. C. Wolff
    • 2
  • P. K. Marcom
    • 3
  • P. A. Kaufman
    • 4
  • L. Zhang
    • 1
  • R. Gelman
    • 1
  • C. Moore
    • 4
  • D. Lake
    • 5
  • G. F. Fleming
    • 6
  • H. S. Rugo
    • 7
  • J. Atkins
    • 8
  • E. Sampson
    • 1
  • D. Collyar
    • 9
  • E. P. Winer
    • 1
  1. 1.Dana-Farber Cancer InstituteBostonUSA
  2. 2.The Sidney Kimmel Cancer Center at Johns HopkinsBaltimoreUSA
  3. 3.Duke University Medical CenterDurhamUSA
  4. 4.Dartmouth Hitchcock Medical CenterLebanonUSA
  5. 5.Memorial Sloan Kettering Cancer CenterNew YorkUSA
  6. 6.University of ChicagoChicagoUSA
  7. 7.University of California San Francisco Comprehensive Cancer CenterSan FranciscoUSA
  8. 8.Southeastern Medical Oncology CenterGoldsboroUSA
  9. 9.Cancer and Leukemia Group B and Patient Advocates in ResearchDanvilleUSA