Smartphone problem-solving and behavioural activation therapy to reduce fear of recurrence among patients with breast cancer (SMartphone Intervention to LEssen fear of cancer recurrence: SMILE project): protocol for a randomised controlled trial

INTRODUCTION: One of the most common distressing conditions experienced by breast cancer survivors is fear of cancer recurrence (FCR). There is, however, no standard intervention for ameliorating FCR. Our clinical experience and previous studies have suggested the potential benefits of problem-solving therapy (PST) and behavioural activation (BA). Given the huge number of cancer survivors and limited number of therapists to competently conduct PST and BA, we have developed PST and BA smartphone applications. This study aimed to evaluate the efficacy of the smartphone-based PST (Kaiketsu-App) and BA (Genki-App) apps in reducing FCR in patients with breast cancer. METHODS AND ANALYSIS: The SMartphone Intervention to LEssen fear of cancer recurrence project is an open-label, individually randomised, parallel-group trial. Allocation will be managed by a central server using a computer-generated random allocation sequence provided by an independent data centre. Participants will be randomised to smartphone-based intervention plus treatment as usual (TAU) or waitlist control with TAU alone. The primary endpoint of the study is the Japanese version of the Concerns About Recurrence Scale, which will be administered as an electronic patient-reported outcome on the patients’ smartphone after 8 weeks. ETHICS AND DISSEMINATION: The present study is subject to the ethical guidelines for clinical studies published by Japan’s Ministry of Education, Science and Technology and Ministry of Health, Labour and Welfare and the modified Act on the Protection of Personal Information as well as the ethical principles established for research on humans stipulated in the Declaration of Helsinki and further amendments thereto. The protocol was approved by the Institutional Review Board of Nagoya City University on 15 January 2018 (ID: 60-00-1171). TRIAL STATUS: The randomised trial, which commenced on 2 April 2018, currently enrols participants. The estimated end date for this study is in March 2020. TRIAL REGISTRATION NUMBER: UMIN000031140; Pre-results.