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

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. Trial registration The 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

Turning a Curve: How People Use Everyday Resources to Negotiate Recovery From Cancer Treatment With Curative Intent

“…A recent review demonstrated that people with early-stage diagnosis, who are more likely to receive treatment with curative intent, may benefit from psychosocial interventions focused on increasing positive affect and building psychological resources (Salsman et al, 2019). Reduction of distress in curatively treated people can also lower health service utilization (Beatty et al, 2022). Interventions aimed at reducing distress currently focus on targeting moderators such as emotional and social functioning (Beatty et al, 2022).…”

“…Reduction of distress in curatively treated people can also lower health service utilization (Beatty et al, 2022). Interventions aimed at reducing distress currently focus on targeting moderators such as emotional and social functioning (Beatty et al, 2022). An assets-based approach to after-care which focuses on exploring existing resources rather than assessing potential deficits in cognitive functioning may offer a wider scope for intervention.…”

Telehealth in breast cancer following the coronavirus disease 2019 pandemic

“…This is a self-guided psychosocial program that is web-based. Beatty et al [ 48 ], published a study protocol to test its efficacy in improving the quality of life of women with metastatic BC. The protocol compares two telehealth interventions FMW-A and the Australian BC Network’s online application “My Journey”, which is a minimal intervention attention control.…”

“…The protocol compares two telehealth interventions FMW-A and the Australian BC Network’s online application “My Journey”, which is a minimal intervention attention control. The hypothesis is that FMW-A can reduce health system burden while mitigating symptoms and enhancing the quality of life of patients with breast metastatic disease [ 48 ]. Examples of on-going trials on telemedicine in BC management after the pandemic are mentioned in Table 2 .…”