© 2003 by Oxford University Press
Journal of the National Cancer Institute, Vol. 95, No. 6, 491-492,
March 19, 2003
© 2003 Oxford University Press
CORRESPONDENCE |
Do Patients Participating in Clinical Trials Want to Know Study Results?
Affiliations of authors: A. H. Partridge, H. J. Burstein, E. P. Winer (Department of Medical Oncology), R. S. Gelman (Department of Biostatistical Science), Dana-Farber Cancer Institute, and Department of Medicine, Brigham and Women’s Hospital, and Harvard Medical School, Boston, MA; P. K. Marcom, Duke University Medical Center, Durham, NC.
Correspondence to: Ann H. Partridge, M.D., M.P.H., Dana-Farber Cancer Institute, 44 Binney St., Boston, MA 02115 (e-mail: ahpartridge{at}partners.org).
Patients with cancer are not routinely provided with results of trials in which they have participated unless the information would influence their future care. In recent years, there has been increasing interest on the part of patient advocates and clinical researchers in offering trial results to all study participants (1,2). The Summit Series on Clinical Trials stated that results of trials, both positive and negative, should be made available to participants and that providing results should be considered the ethical norm (3). We developed and administered a questionnaire to consecutive patients enrolled in a multicenter phase II study for first-line treatment of advanced breast cancer (4) during the outpatient visit on week 2 of treatment, after participating institution local institutional review board approval.
Sixteen sites enrolled patients on the treatment trial, and patients from 15 sites returned surveys. Fifty-one (93%) of 55 patients enrolled on the trial completed the survey. Median age of survey respondents was 54 years (range = 29–82 years) and 84% were white. Ninety-four percent of respondents graduated from high school, and 61% had a college degree (Table 1
).
|
The vast majority (96%, 49 patients) of the 51 patients surveyed indicated that they wanted to be informed of the results of the trial. Ninety-six percent (49 patients) of the 51 patients agreed or strongly agreed with the statement "As a participant in this trial, I believe that I have a ‘right’ to be informed of the results when available." Forty-seven percent (24 patients) of the 51 patients indicated that their interest in the results would be affected by how they personally fared with the treatment. College graduates were less likely to indicate that their interest would be affected by their response to the treatment (26% versus 80%, P<.001).
Although 47% (24 patients) of the 51 patients indicated that their interest in receiving results might vary, 96% (23 patients) of these 24 patients would still want to receive results, even if they did not benefit from the study treatment. Ninety percent (46 patients) of the 51 patients would want their family or loved ones informed of the results if they were unable to learn them. The women indicated that study results could be provided by their physicians (86%), nurses (37%), a member of the research team (45%), or a special person (4%). Thirty-seven percent wanted to be contacted only by their physician. They said results could be shared in various ways including in person (69%), over the telephone (22%), and by mail (69%). Twenty-five percent only wanted to be told the results in person.
There are two important observations from this study. First, most patients surveyed wanted to know the results of their treatment study. Second, many women felt that it should be their doctors who share study results with them. In much the same way that doctors are responsible for obtaining informed consent when entering a patient on study, patients expect their doctors to communicate research results. These findings warrant confirmation and further evaluation among patients in other settings. Although this study was multicenter and included a relatively broad patient population, the small sample size, administration of a single survey per patient, and use of an unvalidated survey limit the generalizability. Despite these limitations, the findings are of interest as efforts are implemented to provide feedback to participants about trial results (1,2,5). Future research should focus on providing trial results to interested participants with follow-up assessments to determine the impact of this information. Such research may ultimately improve patient–provider communication and patient satisfaction with care and could potentially lead to greater clinical trial participation.
NOTES
Supported in part by an American Society of Clinical Oncology Young Investigator Award.
REFERENCES
1 Partridge AH, Winer EP. Informing clinical trial participants about study results. JAMA 2002;288:363–5.
2 Coalition of National Cancer Cooperative Groups, Inc. Guidelines for notifying patients about early closure of cancer clinical trials. 2002. [Last accessed: 02/11/2003.] Available at: www.cancertrialshelp.org/patientAdvocates/policies.jsp.
3 Cancer Leadership Counsel, Cancer Research Foundation of America, Coalition of National Cancer Cooperative Groups, and the Oncology Nursing Society. The Summit Series on Clinical Trials. Increasing Patient Participation. [Last accessed: 02/11/2003.] Available at: http://www.cancersummit.com/pdfs/summit_iii_report.pdf.
4 Burstein HJ, Kuter I, Campos SM, Gelman RS, Tribou L, Parker LM, et al. Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. J Clin Oncol 2001;19:2722–30.
5 Shurin S. Bioethics Committee: report and invitation. Child Oncol News 2001;2:14.
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  S D. MacNeil and C. V Fernandez Attitudes of research ethics board chairs towards disclosure of research results to participants: results of a national survey J. Med. Ethics, September 1, 2007; 33(9): 549 - 553. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S D. MacNeil and C. V Fernandez Offering results to research participants BMJ, January 28, 2006; 332(7535): 188 - 189. [Full Text] [PDF]
|
|
|
|
|
|
M. Dixon-Woods, C. Jackson, K. C Windridge, and S. Kenyon Receiving a summary of the results of a trial: qualitative study of participants' views BMJ, January 28, 2006; 332(7535): 206 - 210. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S D MacNeil and C V Fernandez Informing research participants of research results: analysis of Canadian university based research ethics board policies J. Med. Ethics, January 1, 2006; 32(1): 49 - 54. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 H. Rigby and C. V. Fernandez Providing research results to study participants: support versus practice of researchers presenting at the American Society of Hematology annual meeting Blood, August 15, 2005; 106(4): 1199 - 1202. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 D. I. Shalowitz and F. G. Miller Disclosing Individual Results of Clinical Research: Implications of Respect for Participants JAMA, August 10, 2005; 294(6): 737 - 740. [Full Text] [PDF]
|
|
|
|
 |
|
 C. V. Fernandez, C. Skedgel, and C. Weijer Considerations and costs of disclosing study findings to research participants Can. Med. Assoc. J., April 27, 2004; 170(9): 1417 - 1419. [Full Text] [PDF]
|
|
|
|
 |
|
 A. H. Partridge, N. Hackett, E. Blood, R. Gelman, S. Joffe, S. Bauer-Wu, K. Knudsen, K. Emmons, D. Collyar, R. L. Schilsky, et al. Oncology Physician and Nurse Practices and Attitudes Regarding Offering Clinical Trial Results To Study Participants J Natl Cancer Inst, April 21, 2004; 96(8): 629 - 632. [Abstract] [Full Text] [PDF]
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||