Study protocol of the SWORD-study: a randomised controlled trial comparing combined online and face-to-face cognitive behaviour therapy versus treatment as usual in managing fear of cancer recurrence

Marieke A van de Wal, Marieke FM Gielissen, Petra Servaes, Hans Knoop, Anne EM Speckens, Judith B Prins

Fear of cancer recurrence (FCR) is one of the most frequently cited problems by cancer survivors. More than one third report high FCR, which is a clinical concern due to its association with negative health outcomes. The aim of the current study is to evaluate the efficacy of cognitive behaviour therapy (CBT) in reducing FCR in high fearful cancer survivors. The SWORD-study has a randomised controlled design with two arms. A sample of 104 high fearful cancer survivors (breast, prostate or colorectal cancer) will be recruited from local hospitals. Cancer survivors will be randomised to receive CBT (intervention condition) or treatment as usual (control condition). For those in the intervention condition, the therapy will be individually delivered in a combination of 5 face-to-face therapy sessions and 3 online or telephone sessions by a trained therapist. Furthermore, these survivors will have access to a supportive website (or workbook) throughout the therapy. Survivors in the control condition will not receive the intervention and will not have access to the website. The primary outcome will be severity of fear of recurrence (Cancer Worry Scale). Quality of life (EORTC Quality of Life Questionnaire Core 30) and general psychological wellbeing will be assessed as secondary outcomes. Assessments will take place at baseline (before random assignment), at 3, 9 and 15 months after the baseline assessment. The study has been approved by an ethical review board. If the intervention proves to be effective an evidence-based therapy to manage high FCR will become available for use in clinical practice.