TY - JOUR
T1 - Efficacy and cost-effectiveness of an online mindfulness program (MindOnLine) to reduce fear of recurrence among people with cancer
T2 - Study protocol for a randomised controlled trial
AU - Livingston, Patricia M.
AU - Russell, Lahiru
AU - Orellana, Liliana
AU - Winter, Natalie
AU - Jefford, Michael
AU - Girgis, Afaf
AU - Austin, David
AU - Eric, O.
AU - Mihalopoulos, Cathrine
AU - Ugalde, Anna
AU - Chambers, Richard
AU - Phipps-Nelson, Jo
AU - Herath, Dishan
AU - Botti, Mari
AU - Rasmussen, Bodil
AU - Whitfield, Kathryn
AU - Ftanou, Maria
AU - Smith, Allan Ben
AU - Pilatti, Kirsten
AU - Sara, Sally
AU - Wootten, Addie
AU - Gillan, Kate
AU - Singh, Madhu
AU - Campbell, David
AU - Pillay, Brindha
AU - White, Victoria
N1 - Funding Information:
Funding This study is funded by the National Health and Medical Research Council (NHMRC) Partnership Grant ID APP1179317. The funder supported the cost of undertaking the project.
Publisher Copyright:
©
PY - 2022/1
Y1 - 2022/1
N2 - 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.
AB - 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.
KW - health economics
KW - oncology
KW - world wide web technology
UR - https://www.scopus.com/pages/publications/85123567850
U2 - 10.1136/bmjopen-2021-057212
DO - 10.1136/bmjopen-2021-057212
M3 - Article
C2 - 35022179
AN - SCOPUS:85123567850
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 1
M1 - e057212
ER -
SDG 3 Good Health and Well-being