Efficacy and cost-effectiveness of an online mindfulness program (MindOnLine) to reduce fear of recurrence among people with cancer: study protocol for a randomised controlled trial

Patricia M Livingston; Lahiru Russell; Liliana Orellana; Natalie Winter; Michael Jefford; Afaf Girgis; David Austin; Eric O; Cathrine Mihalopoulos; Anna Ugalde; Richard Chambers; Jo Phipps-Nelson; Dishan Herath; Mari Botti; Bodil Rasmussen; Kathryn Whitfield; Maria Ftanou; Allan Ben Smith; Kirsten Pilatti; Sally Sara; Addie Wootten; Kate Gillan; Madhu Singh; David Campbell; Brindha Pillay; Victoria White

doi:10.1136/bmjopen-2021-057212

Efficacy and cost-effectiveness of an online mindfulness program (MindOnLine) to reduce fear of recurrence among people with cancer: study protocol for a randomised controlled trial

BMJ Open. 2022 Jan 12;12(1):e057212. doi: 10.1136/bmjopen-2021-057212.

Authors

Patricia M Livingston^{1

2}, Lahiru Russell³, Liliana Orellana⁴, Natalie Winter³, Michael Jefford⁵, Afaf Girgis⁶, David Austin², Eric O², Cathrine Mihalopoulos⁷, Anna Ugalde³, Richard Chambers⁸, Jo Phipps-Nelson⁹, Dishan Herath¹⁰, Mari Botti^{3

11}, Bodil Rasmussen^{3

10}, Kathryn Whitfield¹², Maria Ftanou¹³, Allan Ben Smith⁶, Kirsten Pilatti¹⁴, Sally Sara¹⁵, Addie Wootten¹⁶, Kate Gillan¹⁷, Madhu Singh¹⁸, David Campbell¹⁸, Brindha Pillay¹³, Victoria White¹⁹

Affiliations

¹ Centre for Quality and Patient Safety Research in the Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia [email protected].
² Faculty of Health, Deakin University, Geelong, Victoria, Australia.
³ Centre for Quality and Patient Safety Research in the Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia.
⁴ Biostatistics Unit, Faculty of Health, Deakin University, Geelong, Victoria, Australia.
⁵ Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
⁶ Centre for Oncology Education and Research Translation (CONCERT), Ingham Institute for Applied Medical Research, University of New South Wales, Liverpool BC, New South Wales, Australia.
⁷ Institute for Health Transformation, School of Health and Social Development, Deakin University Faculty of Health, Geelong, Victoria, Australia.
⁸ Centre for Contemplative & Consciousness Studies, Monash University, Melbourne, Victoria, Australia.
⁹ Health Services Research & Implementation Science, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
¹⁰ Cancer Services, Western Health, Melbourne, Victoria, Australia.
¹¹ Epworth HealthCare, Melbourne, Victoria, Australia.
¹² Cancer Support Treatment and Research Unit; Community Based Health Services; Commissioning and System Improvement, Department of Health, Melbourne, Victoria, Australia.
¹³ Department of Clinical Psychology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
¹⁴ Breast Cancer Network Australia, Melbourne, Victoria, Australia.
¹⁵ Nursing Programs, Prostate Cancer Foundation of Australia, St Leonards, New South Wales, Australia.
¹⁶ Smiling Mind, Melbourne, Victoria, Australia.
¹⁷ Clinical Services, Epworth HealthCare, Richmond, Victoria, Australia.
¹⁸ Andrew Love Cancer Centre, Barwon Health, University Hospital, Geelong, Victoria, Australia.
¹⁹ School of Psychology, Deakin University, Geelong, Victoria, Australia.

Abstract

Introduction: Fear of cancer recurrence (FCR) is a common condition among cancer survivors that can lead to significant levels of distress, anxiety and depression. Online mindfulness programmes may provide the mechanism to support cancer survivors manage FCR and distress, and improve people's well-being over the short, medium and long term. The primary aim of this study is to determine the potential efficacy of MindOnLine, a 9 session mindfulness-based programme for survivors of breast, prostate and colorectal cancer. A formal economic programme will also be conducted.

Methods and analysis: A single-blind randomised controlled trial to determine the efficacy and cost-efficacy of a MindOnLine programme for cancer survivors. A total of 400 people living with cancer will be recruited via online advertisements on social media platforms, peak consumer advocacy groups or through outpatient services at healthcare providers across Victoria, Australia. People will be randomly allocated to either the MindOnLine programme (n=200) or waitlist control (n=200). Participant assessments will occur at baseline, at 9 weeks and 9-month follow-up. The primary outcome is change in Fear of Recurrence Index Score total score between baseline and 9 weeks; secondary outcomes are changes in depression and anxiety, quality of life and mindfulness. The economic analysis comprises a cost-consequences analysis where all outcomes will be compared with costs.

Ethics and dissemination: Ethics approval was obtained from the Peter MacCallum Cancer Centre (20-53) and Deakin University (2020-284). All participants will be required to provide written informed consent. Findings will be disseminated in peer reviewed journals and among key stakeholder organisations including hospitals, cancer and community organisations and Government. If successful the project will be rolled out nationally with a formal implementation plan.

Trial registration number: Australian New Zealand Clinical Trials Registry (12620000645954); Pre-results. Registered 6 June 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379520&isReview=true.

Keywords: health economics; oncology; world wide web technology.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Cost-Benefit Analysis
Fear
Humans
Male
Mindfulness*
Neoplasms* / therapy
Quality of Life
Randomized Controlled Trials as Topic
Single-Blind Method
Victoria

Associated data

ANZCTR/ACTRN12620000645954