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

Poster

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

Abstract

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; Siebenhüner, 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.
Online Fachtagung | chronisch krank in der digitalen Welt | 13.01.2021
Online Fachtagung
«Chronisch krank in der digitalen Welt»
ABSTRACT – Raum 10
Development of a mindfulness and relaxation app and evaluation of the
effectiveness on cancer patients’ distress: a randomized controlled
multicenter study
Autoren: S. Schläpfer, J. Stanic, M. Eicher T. Kowatsch, C.M. Witt, J. Barth
Organisationen: 1 Institute for Complementary and Integrative Medicine, University Hospital
Zurich and University of Zurich, Zurich, Switzerland
2 IUFRS Institute of Higher Education and Research in Healthcare, Faculty of
Biology and Medicine, University of Lausanne and Lausanne University
Hospital, Lausanne, Switzerland
3 Departement of Oncology, CHUV, Lausanne, Switzerland
4 Center for Digital Health Interventions, Department of Management,
Technology, and Economics, ETH Zurich, Zurich, Switzerland
5 Institute of Technology Management, University of St. Gallen, St. Gallen,
Switzerland
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; Siebenhner, 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
Online Fachtagung | chronisch krank in der digitalen Welt | 13.01.2021
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.
References:
Mikolasek, M., Witt, C.M., & Barth, J. (2018). Adherence to a mindfulness and relaxation self-care
app for cancer patients. A mixed-methods feasibility study. JMIR mHealth uHealth, 6(12):e11271.
Mikolasek, M., Witt, C.M., & Barth, J. (in press). Effects and Implementation of a Mindfulness and
Relaxation App for Cancer Patients: Mixed-Methods Feasibility Study. JMIR Cancer.
https://doi.org/10.2196/16785
Siebenhner, A. R., Mikolasek, M., Witt, C.M., & Barth, J. (in press). Improvements in health might
contradict adherence to mHealth interventions: Findings from a self-care cancer app study.
JACM.
ResearchGate has not been able to resolve any citations for this publication.
Article
Full-text available
Background Cancer diagnosis and cancer treatment can cause high levels of distress, which is often not sufficiently addressed in standard medical care. Therefore, a variety of supportive nonpharmacological treatments have been suggested to reduce distress in patients with cancer. However, not all patients use these interventions because of limited access or lack of awareness. To overcome these barriers, mobile health may be a promising way to deliver the respective supportive treatments. Objective The aim of this study is to evaluate the effects and implementation of a mindfulness and relaxation app intervention for patients with cancer as well as patients’ adherence to such an intervention. Methods In this observational feasibility study with a mixed methods approach, patients with cancer were recruited through the web and through hospitals in Switzerland. All enrolled patients received access to a mindfulness and relaxation app. Patients completed self-reported outcomes (general health, health-related quality of life, anxiety, depression, distress, mindfulness, and fear of progression) at baseline and at weeks 4, 10, and 20. The frequency of app exercise usage was gathered directly through the app to assess the adherence of patients. In addition, we conducted interviews with 5 health professionals for their thoughts on the implementation of the app intervention in standard medical care. We analyzed patients’ self-reported outcomes using linear mixed models (LMMs) and qualitative data with content analysis. ResultsA total of 100 patients with cancer (74 female) with a mean age of 53.2 years (SD 11.6) participated in the study, of which 25 patients used the app regularly until week 20. LMM analyses revealed improvements in anxiety (P=.04), distress (P
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
  • M Witt
  • C M Barth
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. References: Mikolasek, M., Witt, C.M., & Barth, J. (2018). Adherence to a mindfulness and relaxation self-care app for cancer patients. A mixed-methods feasibility study. JMIR mHealth uHealth, 6(12):e11271.