To randomize or not to randomize?: An analysis of women’s willingness to be randomized in a DCIS treatment de-escalation trial

The standard treatment for women with low-grade DCIS currently consists of surgery and/or radiation followed by a mammogram. To reduce over treatment, a phase III randomized clinical trial (the LORD) was set up to investigate an alternative treatment strategy, namely active surveillance. The LORD’s accrual rate, however, was poor and led to a change in study design. This thesis investigated self-reported reasons women joined or did not join the LORD, and the influence of specific treatment preference, cancer worry, anxiety, and tolerance of uncertainty on women’s willingness to be randomized in the LORD. The sample size consisted of 70 women diagnosed with low-risk DCIS, from 42 different hospitals in the Netherlands who completed questionnaires. A qualitative analysis was done on the self-reported reasons women listed, and logistic regression analyses were used to examine the influence of the factors of interest. Results indicate that randomization preference is not associated with...Show moreThe standard treatment for women with low-grade DCIS currently consists of surgery and/or radiation followed by a mammogram. To reduce over treatment, a phase III randomized clinical trial (the LORD) was set up to investigate an alternative treatment strategy, namely active surveillance. The LORD’s accrual rate, however, was poor and led to a change in study design. This thesis investigated self-reported reasons women joined or did not join the LORD, and the influence of specific treatment preference, cancer worry, anxiety, and tolerance of uncertainty on women’s willingness to be randomized in the LORD. The sample size consisted of 70 women diagnosed with low-risk DCIS, from 42 different hospitals in the Netherlands who completed questionnaires. A qualitative analysis was done on the self-reported reasons women listed, and logistic regression analyses were used to examine the influence of the factors of interest. Results indicate that randomization preference is not associated with specific treatment preference, cancer worry, or tolerance of uncertainty. Findings do suggest that women with higher levels of anxiety were less willing to be randomized (OR = .92, p = .10). Further, the qualitative analysis shows women who agreed to randomization seem to be driven by altruistic motives, whereas women who declined randomization seem to be more concerned with autonomy. Finally, both groups expressed a preference for active surveillance. This thesis forms a basis of understanding why women are (not) willing to join the LORD, and suggest more research be done into other factors such as optimism, altruism, autonomy, and patient understanding, specifically in the DCIS population.Show less

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To randomize or not to randomize? An analysis of women’s willingness to be randomized in a DCIS treatment de-escalation trial