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

backgroundThis 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.

methodsWe 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.

resultsThere 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.