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 < or = 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.
RCT Entities:
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 < or = 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 cancerpatient 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: Christine M Fisher; Patricia Troncoso; David A Swanson; Mark F Munsell; Deborah A Kuban; Andrew K Lee; Shih-Fan Yeh; Steven J Frank Journal: Brachytherapy Date: 2012-06-21 Impact factor: 2.362
Authors: Matthew R Cooperberg; Naren R Ramakrishna; Steven B Duff; Kathleen E Hughes; Sara Sadownik; Joseph A Smith; Ashutosh K Tewari Journal: BJU Int Date: 2012-12-28 Impact factor: 5.588
Authors: Jennifer K Logan; Chad Tang; Zhongxing Liao; J Jack Lee; John V Heymach; Stephen G Swisher; James W Welsh; Jianjun Zhang; Steven H Lin; Daniel R Gomez Journal: Int J Radiat Oncol Biol Phys Date: 2016-11-27 Impact factor: 7.038
Authors: Lydia T Madsen; Deborah A Kuban; Seungtaek Choi; John W Davis; Jeri Kim; Andrew K Lee; Delora Domain; Larry Levy; Louis L Pisters; Curtis A Pettaway; John F Ward; Christopher Logothetis; Karen E Hoffman Journal: J Natl Compr Canc Netw Date: 2014-07 Impact factor: 11.908
Authors: Daniel A Barocas; Vivien Chen; Matthew Cooperberg; Michael Goodman; John J Graff; Sheldon Greenfield; Ann Hamilton; Karen Hoffman; Sherrie Kaplan; Tatsuki Koyama; Alicia Morgans; Lisa E Paddock; Sharon Phillips; Matthew J Resnick; Antoinette Stroup; Xiao-Cheng Wu; David F Penson Journal: J Comp Eff Res Date: 2013-07 Impact factor: 1.744
Authors: S M Miller; S V Hudson; B L Egleston; S Manne; J S Buzaglo; K Devarajan; L Fleisher; J Millard; N Solarino; J Trinastic; N J Meropol Journal: Psychooncology Date: 2012-02-14 Impact factor: 3.894