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. 2022 Jan 12;12(1):e057212.
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

Patricia M Livingston  1   2 , Lahiru Russell  3 , Liliana Orellana  4 , Natalie Winter  3 , Michael Jefford  5 , Afaf Girgis  6 , David Austin  2 , Eric O  2 , Cathrine Mihalopoulos  7 , Anna Ugalde  3 , Richard Chambers  8 , Jo Phipps-Nelson  9 , Dishan Herath  10 , Mari Botti  3   11 , Bodil Rasmussen  3   10 , Kathryn Whitfield  12 , Maria Ftanou  13 , Allan Ben Smith  6 , Kirsten Pilatti  14 , Sally Sara  15 , Addie Wootten  16 , Kate Gillan  17 , Madhu Singh  18 , David Campbell  18 , Brindha Pillay  13 , Victoria White  19
Affiliations

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 et al. BMJ Open. .

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.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Study flow chart. AQoL-4D, Assessment of Quality of Life-4 Dimensions; CAMS-R, Cognitive and Affective Mindfulness Scale-Revised; FCRI, Fear of Cancer Recurrence Inventory; GAD-7, General Anxiety and Distress Scale; PHQ-9, Patient Health Questionnaire.
Figure 2
Figure 2
My Goal functionality in MindOnLine.
Figure 3
Figure 3
My Journal-guided self-reflection practise in MindOnLine.
See this image and copyright information in PMC

References

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