Head to head randomized trial of two decision aids for prostate cancer

Abstract

Background While many studies have tested the impact of a decision aid (DA) compared to not receiving any DA, far fewer have tested how different types of DAs affect key outcomes such as treatment choice, patient–provider communication, or decision process/satisfaction. This study tested the impact of a complex medical oriented DA compared to a more simplistic decision aid designed to encourage shared decision making in men with clinically localized prostate cancer. Methods 1028 men at 4 VA hospitals were recruited after a scheduled prostate biopsy. Participants completed baseline measures and were randomized to receive either a simple or complex DA. Participants were men with clinically localized cancer (N = 285) by biopsy and who completed a baseline survey. Survey measures: baseline (biopsy); immediately prior to seeing the physician for biopsy results (pre- encounter); one week following the physician visit (post-encounter). Outcome measures included treatment preference and treatment received, knowledge, preference for shared decision making, decision making process, and patients’ use and satisfaction with the DA. Results Participants who received the simple DA had greater interest in shared decision making after reading the DA (p = 0.03), found the DA more helpful (p’s < 0.01) and were more likely to be considering watchful waiting (p = 0.03) compared to those receiving the complex DA at Time 2. While these differences were present before patients saw their urologists, there was no difference between groups in the treatment patients received. Conclusions The simple DA led to increased desire for shared decision making and for less aggressive treatment. However, these differences disappeared following the physician visit, which appeared to change patients’ treatment preferences. Trial registration This trial was pre-registered prior to recruitment of participants.

Examining the effectiveness and implementation of patient treatment decision‐aid tools for men with localised prostate cancer: A systematic review

“…From these, 98 articles were excluded for not meeting the eligibility criteria. A total of 24 articles 21–44 were included for the analysis (7 non‐randomised studies, 16 randomised control trial (RCT) studies, and one qualitative study). Three articles 21,23,26 had their data combined with trials reporting results from the same study 22,24,27 leaving 21 original studies.…”

“…Lower scores in non‐RCT studies were largely due to confounders in design and analysis not being accounting for. One RCT 31 study and one qualitative study 35 included in our analysis scored 100%.…”

“…Three studies recruited patients only from urology clinics 28,32,44 . Various studies specifically recruited from a multidisciplinary genitourinary oncology clinic, 38 a telephone‐based cancer information service, 30 and veterans' administration centers 31 . One study did not specify the recruitment setting 34 …”

“…Most DAs discussed treatment options including “watchful waiting” (treating symptoms as they arise) or AS (planned, regular surveillance of the cancer), surgery options (open/robotic‐assisted radical prostatectomy), and radiation therapy (external beam radiation, brachytherapy). Four studies also included the treatment option of hormonal therapy 31,32,41,42 …”

“…Davison and colleagues 28 compared an individualised DA with a generic DA, while Taylor and colleagues 42 assessed an interactive CD‐ROM DA with an information only DA. One study compared a simple booklet DA to a complex booklet DA 31 . Holmes‐Rovner and colleagues 34 used historical controls to compare their DA intervention.…”