Randomized Controlled Trial of the Meaning‐Making Intervention (MMi) in Patients Newly Diagnosed With Advanced Cancer: Full Trial

Background This study aimed to test whether the Meaning‐Making intervention (MMi) increases the sense of meaning in life in people newly diagnosed with any type of advanced cancer. Methods We conducted a 3‐arm parallel randomized controlled trial with 239 patients newly diagnosed (< 6 months) with advanced cancer (stages III or IV), assigned to either an experimental group ( n = 80), an attention‐control group ( n = 80), or a usual care control group ( n = 79). Meaning in life (primary outcome), anxiety and depression, quality of life, existential wellbeing, and posttraumatic growth were measured at 2 months post randomization with follow‐up at 4 and 6 months. Results There were no significant ( p < 0.05) inter‐group differences in FACIT‐Sp‐12 Meaning subscale scores 2 months post‐randomization in independent two‐sample t ‐tests (experimental group vs. usual care p = 0.65; experimental group vs. attention control p = 0.94), nor at 2, 4, and 6 months post‐randomization using a mixed effect linear regression model and adjusting for baseline characteristics and random effect of time ( p = 0.55–0.99). In exploratory analyses, stage III experimental group participants seemed to present higher post‐traumatic growth on the PTGI 2 months post‐randomization than patients in the AC ( p = 0.02), but this was not significant when applying a Bonferroni correction for multiple comparisons. Clinical implications In this three‐arm randomized controlled trial, the MMi did not produce improvements on the primary or secondary outcomes compared with AC or UC. There may be some indications of a signal for benefit for patients with stage III cancer, which warrant follow‐up but cannot be considered definitive. Future work should prioritize targeting, dose, timing, and contextual moderators to clarify when, and for whom, meaning‐focused approaches are most effective.