A Double-Blind Randomized Sham-Controlled Trial of Two Online Cognitive Bias Modification Interventions for Fear of Cancer Recurrence in People With Breast or Ovarian Cancer

Abstract

Objective: In the context of cancer, pain demands interpretation. Our research has found that fear of cancer recurrence (FCR) is associated with the tendency to interpret ambiguous information as health-related. We aimed to determine whether we could modify these interpretation biases to improve FCR, and pain outcomes. Methods: We conducted a double-blind randomized controlled trial comparing two fully automated Cognitive Bias Modification for Interpretation (CBM-I) programs to a matched sham. We randomized 174 people with breast or ovarian cancer to one of three groups (pain-related CBM, cancer-specific CBM or sham). Participants completed four training sessions, and outcomes were assessed before and after intervention and 2 weeks later. We nominated co-primary outcomes as FCR and fear of progression (FoP) so that measures were suited to those with and without active disease and measured pain outcomes and other secondary psychosocial outcomes. Results: We analyzed data using mixed-model linear regression and intention-to-treat. Results indicated that both the cancer-specific and pain-related training groups showed significant improvements in FCR (F(2,440) = 17.19, p < 0.0005) and FoP (F(2,440) = 15.03, p < 0.0005) over time compared to sham. Both versions of CBM were associated with benefits in pain intensity (F(2,440) = 6.14, p < 0.0005) and pain interference (F(2,440) = 5.223, p = 0.001) compared to sham. No other secondary outcomes improved. Conclusion: CBM for interpretation is an efficacious treatment for FCR, FoP and pain outcomes in ovarian and breast cancer. This intervention was delivered wholly online, had high completion rates (80%) and therefore is highly scalable. CBM-I could be part of a stepped care model to meet the large unmet need for people who are living with and beyond cancer.