This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Wallace, K. Articles by Crook, J. Search for Related Content PubMed Articles by Wallace, K. Articles by Crook, J. Social Bookmarking                            What's this?

Impact of a Multi-Disciplinary Patient Education Session on Accrual to a Difficult Clinical Trial: The Toronto Experience With the Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial

Kris Wallace, Neil Fleshner, Michael Jewett, Joan Basiuk, Juanita Crook

From the Departments of Radiation Medicine and the Division of Urology and Department of Surgical Oncology, Princess Margaret Hospital, University Health Network, Toronto, Canada

Address reprint requests to Juanita Crook, MD, FRCPC, Princess Margaret Hospital, 610 University Ave, Toronto, Canada, M5G 2M9; e-mail: juanita.crook{at}rmp.uhn.on.ca

Purpose Random assignment to clinical trials involving different treatment modalities can be difficult. We describe our experience with the Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial (SPIRIT; ACOSOG Z0070 NCIC PR10), a randomized trial for early-stage prostate cancer comparing radical prostatectomy (RP), and brachytherapy (BT). A multidisciplinary educational session was developed to improve patient understanding of treatment options and to facilitate accrual.

Patients and Methods Prostate cancer referrals were screened and men who met favorable risk criteria (T1c/T2a, prostate-specific antigen [PSA] < 10 ng/mL, Gleason 6) were invited to a structured education session before a specialty consultation. Men and their partners viewed the SPIRIT informed-consent video and heard from a cancer patient who described his participation in a randomized trial. Then, a urologist and radiation oncologist together compared and contrasted RP and BT to establish the rationale for the trial.

Results In May 2002, SPIRIT opened for accrual and was endorsed by the University Health Network urologists and radiation oncologists. The first 27 eligible patients were approached about SPIRIT, consulted both specialties, and viewed an educational video. No patients consented. The multidisciplinary education session was then introduced. Forty-seven education sessions with 263 patients resulted in 34 consents. Of 203 patients who were suitable for the study but declined random assignment, 62 chose surgery, 94 chose brachytherapy, three patients chose external radiotherapy, and 11 chose no treatment. Consent rates for eligible and suitable patients were one in six.

Conclusion Men who understand their treatment options and trial rationale as presented jointly by representative specialists from competing treatment modalities may be better equipped to make an informed decision and are more likely to consent to random assignment.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				M. G. Sanda and I. D. Kaplan A 64-Year-Old Man With Low-Risk Prostate Cancer: Review of Prostate Cancer Treatment JAMA, May 27, 2009; 301(20): 2141 - 2151. [Abstract] [Full Text] [PDF]

				I. Juraskova, P. Butow, A.-L. Lopez, M. Seccombe, F. Boyle, N. McCarthy, and J. F. Forbes Improving Informed Consent in Clinical Trials: Successful Piloting of a Decision Aid J. Clin. Oncol., April 10, 2007; 25(11): 1443 - 1444. [Full Text] [PDF]