Providing information about potential prostate cancer treatment options to men preparing to undergo a prostate cancer biopsy was well received by patients, and did not appear to increase anxiety. This finding is consistent with prior evaluations of DA among newly diagnosed men which have consistently shown that DA do not increase anxiety [26
]. However, to our knowledge this is the first study administering education about cancer treatment options to patients before they are definitively diagnosed with cancer. Undergoing a biopsy is stressful [27
] and there are concerns that providing information about cancer treatment options to men who have not yet been diagnosed may be inappropriate. However, the biopsy process may also be a unique chance to engage men in preparing for the treatment decision-making process and provide a better opportunity to process nuanced information about the risks and benefits of treatment before they have to psychologically cope with a cancer diagnosis [28
]. Our finding that providing information to patients at this unique timepoint did not increase anxiety, but rather seemed to lower anxiety and improve overall quality of life, provides strong preliminary support for engaging patients about potential treatment options early in the biopsy process.
Men receiving the educational intervention exhibited increased knowledge, although the difference did not reach statistical significance. In addition to general knowledge about risks and benefits of prostate cancer treatment, men who received the intervention reported being more familiar with available treatment options, including active surveillance. However, the gains in knowledge were only observed shortly after receiving the intervention. By the time men were diagnosed with cancer, knowledge scores and familiarity with treatment options was nearly identical between the ED and UC groups. One unexpected finding was that the intervention prompted some men to use the internet to learn more about prostate cancer. This may be because the intervention materials provided the website URLs for additional resources or the materials may have raised additional questions that men wanted to learn more about.
Although the sample size is small, every patient who received the intervention and went on to be diagnosed with cancer indicated they were “clear about the risks and side effects of each treatment option” and that they were “clear of which risks and side effects matter most to you,” compared to only half of participants in the UC group who were diagnosed with cancer (p
0.07). These two items from the Decisional Conflict Scale highlight one of the key dimensions of prostate cancer treatment decision making – that each of the treatment options differ in its side effect profile [1
]. While there continues to be uncertainty about how best to measure outcomes of decision support interventions [29
], this trend may indicate that the ED seemed to increase patient familiarity with side effects of prostate cancer treatments. One prior study of prostate cancer DA has examined decisional conflict, which was a trial among newly diagnosed men comparing a generic video about prostate cancer treatment options or combining the video with a computer program to identify tailored information preferences to provide to patients [5
]. This study did not observe a difference in decisional conflict between the two groups (p
0.40), noting that decisional conflict was low in both groups at baseline.
Our feasibility study has several limitations. First, our study was small, with a total of 29 men participating in the baseline evaluation. Only 9 participants diagnosed with cancer and 13 with negative biopsies participated in the follow-up evaluation. Although all measures appeared to favor the ED intervention, this small sample size precludes making any firm conclusions. Although p-values are provided, they should be interpreted with caution as this study was not powered to test specific hypotheses about the ED. Second, our study was conducted exclusively within a single VA urology clinic and our findings may not be generalizable to other settings. Third, although randomization was blinded, the remaining activities of the study were not. Men were aware of which study group they were assigned, and although the study interviewer was not specifically told which group the participants had been assigned, during the interview participants were asked to describe the study materials, effectively un-blinding the interviewer. Another limitation is that we explored multiple instruments, many of which were developed for patients with cancer, which was different from the context of our study. We acknowledge that the psychometric properties of the instruments in this context have not been evaluated.