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

Publication ,  Journal Article
Partridge, AH; Wolff, AC; Marcom, PK; Kaufman, PA; Zhang, L; Gelman, R; Moore, C; Lake, D; Fleming, GF; Rugo, HS; Atkins, J; Sampson, E ...
Published in: Breast Cancer Res Treat
May 2009

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.

Duke Scholars

Published In

Breast Cancer Res Treat

DOI

EISSN

1573-7217

Publication Date

May 2009

Volume

115

Issue

1

Start / End Page

123 / 129

Location

Netherlands

Related Subject Headings

  • Trastuzumab
  • Research Design
  • Regression Analysis
  • Recurrence
  • Randomized Controlled Trials as Topic
  • Perception
  • Patient Satisfaction
  • Patient Education as Topic
  • Oncology & Carcinogenesis
  • Middle Aged
 

Citation

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Partridge, A. H., Wolff, A. C., Marcom, P. K., Kaufman, P. A., Zhang, L., Gelman, R., … Winer, E. P. (2009). The impact of sharing results of a randomized breast cancer clinical trial with study participants. Breast Cancer Res Treat, 115(1), 123–129. https://doi.org/10.1007/s10549-008-0057-7
Partridge, Ann H., A. C. Wolff, P. K. Marcom, P. A. Kaufman, L. Zhang, R. Gelman, C. Moore, et al. “The impact of sharing results of a randomized breast cancer clinical trial with study participants.Breast Cancer Res Treat 115, no. 1 (May 2009): 123–29. https://doi.org/10.1007/s10549-008-0057-7.
Partridge AH, Wolff AC, Marcom PK, Kaufman PA, Zhang L, Gelman R, et al. The impact of sharing results of a randomized breast cancer clinical trial with study participants. Breast Cancer Res Treat. 2009 May;115(1):123–9.
Partridge, Ann H., et al. “The impact of sharing results of a randomized breast cancer clinical trial with study participants.Breast Cancer Res Treat, vol. 115, no. 1, May 2009, pp. 123–29. Pubmed, doi:10.1007/s10549-008-0057-7.
Partridge AH, Wolff AC, Marcom PK, Kaufman PA, Zhang L, Gelman R, Moore C, Lake D, Fleming GF, Rugo HS, Atkins J, Sampson E, Collyar D, Winer EP. The impact of sharing results of a randomized breast cancer clinical trial with study participants. Breast Cancer Res Treat. 2009 May;115(1):123–129.
Journal cover image

Published In

Breast Cancer Res Treat

DOI

EISSN

1573-7217

Publication Date

May 2009

Volume

115

Issue

1

Start / End Page

123 / 129

Location

Netherlands

Related Subject Headings

  • Trastuzumab
  • Research Design
  • Regression Analysis
  • Recurrence
  • Randomized Controlled Trials as Topic
  • Perception
  • Patient Satisfaction
  • Patient Education as Topic
  • Oncology & Carcinogenesis
  • Middle Aged