Development of a mindfulness and relaxation app and evaluation of the effectiveness on cancer patients’ distress: a randomized controlled multicenter study

Background: Mind-body interventions have the potential to reduce cancer patients’ distress during initial care and rehabilitation, but access to face-to-face interventions is often limited due to entry barriers such as geographical distance, time, financial constraints, or lack of service providers, or due to rules on hygiene and social distancing such as those associated with the recent COVID- 19 pandemic. Mobile applications (apps) can overcome some of these barriers. A mixed-methods feasibility study with our mindfulness and relaxation app for cancer patients (CAN Relax app 1.0) showed good acceptance of the app, adherence to the exercises, and changes in distress while using the app (Mikolasek, Witt, & Barth, 2018; Mikolasek et al., in press; Siebenhuner, Mikolasek, Witt, & Barth, in press). But patients’ feedback also revealed areas for improvement which will be addressed in the revised CAN Relax app 2.0. Objective: The aim of the study is to develop the CAN Relax app 2.0 and evaluate its effectiveness to reduce distress in adult cancer patients compared with a waitlist control group in a randomized controlled multicenter trial. Method: The study will be conducted via two study centers in different language regions of Switzerland. Patients diagnosed with any type of cancer within the last 5 years will be included. The primary outcome will be the level of distress over 10 weeks (PHQ-4); secondary endpoints will include quality of life, self-esteem, and attrition. The app will provide several audio-guided mindfulness and relaxation exercises in two languages (German, French). In contrast to the first version, the CAN Relax app 2.0 will include a motivational digital assistant (chatbot), educational video clips on the rationale of the intervention, and a larger selection of audio files. The project started in October 2019. The app development process is ongoing and patient recruitment is expected to begin in mid-2021. The study is funded by the Swiss Cancer Research foundation (Stiftung Krebsforschung Schweiz), KFS 4556-08-2018.