Finding My Way-Advanced: can a web-based psychosocial intervention improve the mental quality of life for women with metastatic breast cancer vs attention-control? Study protocol of a randomised controlled trial

BMC Cancer

Study Protocol

Anthony Daly¹  Nicholas Hulbert-Williams²  Richard Woodman³  Lisa Beatty³  Billingsley Kaambwa³  Emma Kemp³  Bogda Koczwara⁴  Belinda Kiely⁵  Frances Boyle⁶  Amanda Jones⁷  Penelope Schofield⁸  Afaf Girgis⁹  Nicholas Zdenkowski^1,10  Jane Turner^1,11  Phyllis Butow^1,12 

[1] Cancer Council South Australia, Adelaide, Australia;Edge Hill University, Ormskirk, UK;Flinders University, Adelaide, Australia;Flinders University, Adelaide, Australia;Southern Adelaide Local Health Network, Bedford Park, Australia;Macarthur Cancer Therapy Centre, Campbelltown Hospital, Campbelltown, Australia;Mater, Sydney, Australia;Southern Adelaide Local Health Network, Bedford Park, Australia;Swinburne University, Melbourne, Australia;Peter MacCallum Cancer Centre, Melbourne, Australia;University of NSW, Sydney, Australia;University of Newcastle, Newcastle, Australia;University of Queensland, St Lucia, Australia;University of Sydney, Sydney, Australia;

关键词: Metastatic breast cancer;    Psycho-oncology;    Digital health;    Intervention;    QOL;    Distress;    CBT;    RCT;   

DOI  :  10.1186/s12885-022-10410-z

 received in 2022-10-06, accepted in 2022-12-05,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundWomen living with metastatic breast cancer (MBC) are at risk of significantly impaired quality of life (QOL), symptom burden, distress and fear of progression, and unmet needs, yet they face barriers to accessing evidence-based psychosocial treatments. Our group therefore developed Finding My Way-Advanced (FMW-A), a web-based self-guided psychosocial program for women with MBC. This study aims to assess its efficacy in improving mental and other QOL domains, distress, fear of progression, unmet needs, and health service utilisation.MethodsThe multi-site randomised controlled trial (RCT) will enrol 370 Australian participants. Eligible participants are adult (18 years +) women diagnosed with MBC, with a life expectancy of 6 months or more, with sufficient English-language literacy to provide informed consent. Participants will be identified, screened and referred from one of 10 Australian sites, or via self-referral in response to advertisements. Participants complete four online questionnaires: prior to accessing their program (‘baseline’), 6 weeks later (‘post-intervention’), then 3 months and 6 months post-intervention. Consenting participants will be randomised to either FMW-A (intervention), or Breast Cancer Network Australia’s (BCNA) online/app resource My Journey (minimal intervention attention-control). This is a single-blind study, with randomisation computer-generated and stratified by site. FMW-A is a 6-module program addressing some of the most common issues experienced by women with MBC, with BCNA control resources integrated within the ‘resources’ section. All modules are immediately accessible, with an additional booster module released 10 weeks later. The primary outcome is mental QOL; statistical criteria for superiority is defined as a 4-point difference between groups at post-treatment. Secondary outcomes include other QOL domains, distress, fear of progression, health service use, intervention adherence, and user satisfaction.DiscussionThis will be the first adequately powered RCT of a self-directed online intervention for women with MBC. If efficacious, FMW-A will help address two national key priorities for management of MBC – enhancing QOL and reducing symptom burden. FMW-A has the potential to address unmet needs and overcome access barriers for this overlooked population, while reducing health system burden.Trial registrationThe study was registered prospectively with the ANZCTR on 29/10/2021. Trial ID ACTRN12621001482853p. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382714&isReview=true

【 授权许可】

CC BY   
© The Author(s) 2022

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