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

The FMW-A Authorship Group, Lisa Beatty, Emma Kemp, Phyllis Butow, Afaf Girgis, Nicholas Hulbert-Williams, Billingsley Kaambwa, Penelope Schofield, Jane Turner, Richard Woodman, Frances Boyle, Anthony Daly, Amanda Jones, Belinda Kiely, Nicholas Zdenkowski, Bogda Koczwara, Jane Beith, Keelen Byrne, Robyn Combes, Chantal CorthalsM. Nottage, Louise Sinclair, Desmond Yip

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Abstract

Background: Women 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. Methods: The 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. Discussion: This 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. 

Original languageEnglish
Article number1353
Number of pages12
JournalBMC Cancer
Volume22
Issue number1
DOIs
Publication statusPublished - Dec 2022

Keywords

  • CBT
  • Digital health
  • Distress
  • Intervention
  • Metastatic breast cancer
  • Psycho-oncology
  • QOL
  • RCT

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