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

Wallace, Kris; Fleshner, Neil; Jewett, Michael A.S.; Basiuk, Joan; Crook, Juanita

doi:10.1200/jco.2006.06.3875

Cited by 80 publications

(39 citation statements)

References 21 publications

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“…The AVPI could be made specific to an individual trial, although to achieve this would have substantial practical challenges. Wallace et al (2006) a 'difficult' randomised trial with very different treatment options, a multiprofessional education session with patients, which included viewing a customised video, did increase clinical trial consent rates. An important finding for the cancer trial setting, which is consistent with previous work (predominantly from other specialities), was the effectiveness of AVPI in improving knowledge and understanding without increasing anxiety (Luck et al, 1999;Mason et al, 2003).…”

Section: Discussionmentioning

confidence: 99%

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

et al. 2007

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Recruitment to cancer clinical trials needs to be improved, as does patient knowledge and understanding about clinical trials, in order for patients to make an informed choice about whether or not to take part. Audiovisual patient information (AVPI) has been shown to improve knowledge and understanding in various areas of practice, but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to consent rates. In this study, 173 patients were randomised to receive either the AVPI, in addition to the standard trial-specific written information, or the written information alone. There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% CI 0.55 -2.58, P ¼ 0.661). Knowledge scores increased more in the AVPI group compared to the standard group (P ¼ 0.0072). The change in anxiety score between the arms was also statistically significant (P ¼ 0.011) with anxiety improving in the intervention arm more than in the no intervention arm. Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety, but further work is necessary in relation to its effect on clinical trial recruitment rates.

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Section: Discussionmentioning

confidence: 99%

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

et al. 2007

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“…Based on data from the Cancer of the Prostate Strategic Urologic Research Endeavor (1), brachytherapy has become the single most common treatment modality for men with low-risk disease who are older than 75 years. Reported biochemical outcomes after brachytherapy have surpassed outcomes from the surgical literature, although a direct randomized comparison of the two modalities was unsuccessful (2).…”

Section: Introductionmentioning

confidence: 97%

Evaluation of Dosimetric Parameters and Disease Response After 125Iodine Transperineal Brachytherapy for Low- and Intermediate-Risk Prostate Cancer

Morris¹,

Keyes²,

Palma³

et al. 2009

International Journal of Radiation Oncology*Biology*Physics

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“…Attempts at randomized, prospective trials comparing both treatments have failed because patients ultimately prefer to make their own treatment decisions. 1 Furthermore, different definitions of biochemical recurrence (BCR) have been proposed for each treatment. The American Urological Association Prostate Cancer guideline panel recently recommended standardizing the definition of BCR after RP to an initial prostate-specific antigen (PSA) level of 0.2 ng/mL or greater, with a second confirmatory PSA level of 0.2 ng/mL or greater.…”

Section: Introductionmentioning

confidence: 99%

A comparative study of radical prostatectomy and permanent seed brachytherapy for low- and intermediate-risk prostate cancer

Taussky

Ouellet

Delouya

et al. 2016

CUAJ

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Introduction: We sought to compare the outcomes between radical prostatectomy (RP) and permanent seed prostate brachytherapy (PB) in patients with low-and low-intermediate-risk prostate cancer from a single tertiary care centre. Methods: Patients were selected from our institute's internal database based on preoperative selection criteria from the National Comprehensive Cancer Network (NCCN) guidelines (2015) for low-and intermediate-risk patients. No patient had received any neo-adjuvant androgen-deprivation therapy. The endpoint was biochemical recurrence (BCR) or any salvage treatment for both RP and PB at 48 ± 4 months after treatment. The biochemical relapse threshold was set at prostate-specific antigen (PSA) ≥0.5 ng/mL for PB and two PSA values of ≥0.2 ng/mL for RP. Patients from both treatment groups were compared using non-parametric tests. A binary logistic regression analysis was performed to determine an association of treatment and pretreatment factors with a BCR at 48 months. Results: A total of 575 patients were included in this study; 254 were treated with RP and 321 with PB. BCR was not different between both groups (p=0.84, Chi-square test), and occurred in 21.2% of patients treated with RP and in 20.6% with PB. Based on univariate and multivariate logistic regression analyses, younger age, higher percentage of positive biopsies, and initial PSA were predictive of BCR. IntroductionRadical prostatectomy (RP) and permanent seed prostate brachytherapy (PB) are two widely used treatment options for patients with low-and intermediate-risk prostate cancer. Both treatments are similar for excellent cancer control rates and patients often have difficulty deciding between the two. Published studies for both treatments are difficult to compare because of different definitions for recurrence and differences in baseline characteristics, such as age and comorbidity. Attempts at randomized, prospective trials comparing both treatments have failed because patients ultimately prefer to make their own treatment decisions.1 Furthermore, different definitions of biochemical recurrence (BCR) have been proposed for each treatment. The American Urological Association Prostate Cancer guideline panel recently recommended standardizing the definition of BCR after RP to an initial prostate-specific antigen (PSA) level of 0.2 ng/mL or greater, with a second confirmatory PSA level of 0.2 ng/mL or greater.2 The American Society for Therapeutic Radiology and Oncology considers BCR as a rise by 2 ng/mL or more above the nadir PSA (Phoenix definition). 3In this study, we compared patients treated with either RP or PB at a single university hospital, using closely related definitions of BCR. We defined BCR after RP as a PSA level of ≥0.2 ng/mL and BCR after PB as ≥0.5 ng/mL, at four years post-treatment. MethodsWith ethical review board approval, patients were selected as they underwent treatment for their prostate cancer at the

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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

Abstract: 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.

Cited by 80 publications

References 21 publications

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

Evaluation of Dosimetric Parameters and Disease Response After 125Iodine Transperineal Brachytherapy for Low- and Intermediate-Risk Prostate Cancer

A comparative study of radical prostatectomy and permanent seed brachytherapy for low- and intermediate-risk prostate cancer

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