Following first-line treatment, asymptomatic ovarian cancer patients with rising CA-125 levels face a difficult treatment decision with uncertain quality of life and survival outcomes; to commence immediate treatment based on increasing CA-125 alone or to delay second-line treatment until symptoms appear. It is therefore important that women feel supported during the decision-making process, and their treatment decision is informed and guided by their values. To address a paucity of rigorous decision-making studies in this setting, we developed and piloted an evidence-based decision-aid. The current study reports RCT findings on the effectiveness of the decision-aid in reducing decision-making difficulties and decisional regret whilst improving knowledge of the costs-benefits of treatment options and satisfaction with the decision, without increasing anxiety within this clinical population.
Eligible participants were randomised (1:1) to receive either the decision-aid booklet (Intervention) or a standard ovarian cancer information booklet (Control). Participants read through their allocated booklet and completed a series of validated/purpose-designed questionnaires assessing the target variables after they made their treatment decision (T1) and at four months’ follow-up (T2).
46 women completed T1 (Intervention: n=24; Control: n=22) and 37 T2questionnaires (Intervention: n=20, Control: n=17). At T1, the Intervention group demonstrated better understanding of the implications of raising CA-125 levels and more accurate knowledge of the benefits and costs of treatment options, compared to Controls (p<0.001). There were no group differences in: difficulties/satisfaction with decision-making at T1, decisional regret at T2, or in satisfaction with the decision and anxiety at T1 or T2 (p>0.05).
Receiving the DA booklet enhanced women’s understanding of treatment options for asymptomatic ovarian cancer with rising CA-125 levels, without increasing their anxiety. This research program addresses a neglected area in the management of women with ovarian cancer through the delivery of an evidence-based information and decisional support tool.