Efficacy of an online mindfulness program (MindOnLine) to reduce fear of recurrence in people living with-and beyond-breast, prostate or colorectal cancer: a randomized controlled trial.

Background: Fear of cancer recurrence (FCR) is a prevalent and debilitating condition that effects around 60% of people living with cancer. It is severe, persistent, and imposes a significant financial burden on the healthcare system. Given FCR's profound impact on mental health and quality of life, adopting targeted interventions to mitigate its effects is essential. This study reports on the efficacy of MindOnLine, an online mindfulness program, for people living with-and beyond-breast, prostate or colorectal cancer, in reducing FCR, anxiety and depression.

Methods: Randomized controlled trial (1:1) comparing MindOnline with a waitlist group (ANZCTR: 12620000645954). Eligibility criteria: ≥18 years, living in Australia, completed active treatment/surveillance for stages 1-3 breast, prostate or CRC, within the last 5 years, had internet access, and a Fear of Cancer Recurrence Inventory (FCRI) severity score ≥13. MindOnLine was a self-directed, brief, online 9-week program, with a new module unlocked each week. The intervention incorporated education, mindfulness practices, and meditation, to promote awareness and emotion regulation. Data were captured at baseline, 9-weeks and 9-months post-randomization. Linear mixed models assessed MindOnLine's impact on the primary (FCRI total score) and secondary (anxiety (GAD-7), depression (PHQ-9)) outcomes.

Findings: Between October 2020 and June 2023, 434 participants randomized, of which 58% had breast, 26% prostate and 16% colorectal cancer; 70% were female; 50% were aged ≥60 years; and 67.5% resided in metropolitan areas. At 9-weeks, MindOnLine decreased the FCRI total score (-5.61, 95% CI [-8.61, -2.61], p < 0.001); anxiety (-1.29 [-2.15, -0.43], p = 0.003) and depression (-1.47 [-2.34, -0.61], p < 0.001) scores, compared to the waitlist group. Intervention effects were sustained at 9-months (FCRI: -5.06 [-8.61, -1.52]; p = 0.005; anxiety: -1.22 [-2.21, -0.24], p = 0.015; depression: -1.09 [-2.03, -0.16], p = 0.022).

Interpretation: Our findings demonstrate that a self-directed, brief, online mindfulness-based program mitigates moderate or severe fear of cancer recurrence. Further research is necessary to guide the development of future services, policies and practices by identifying how online mindfulness programs can be customized to effectively support diverse population groups, ensuring the programs are effective and accessible and impactful, regardless of their personal circumstances or geographical location.

Funding: This study was funded by the National Health and Medical Research Council (NHMRC) Partnership Grant ID APP1179317, with partner cash contributions from the Department of Health, Victoria, Epworth HealthCare and Western Health.