Effects of a symptom voice diary intervention program in patients with acute leukemia: a randomized controlled trial.

PURPOSE: To evaluate a multicomponent symptom voice diary intervention for adult acute leukemia patients facing severe symptom burden and psychological distress during intensive chemotherapy. The primary outcome was anxiety; secondary outcomes included depression, psychological distress, health-related quality of life (QoL), and general self-management. METHODS: A two-arm, parallel-group randomized controlled trial was conducted among adults newly diagnosed with acute leukemia. Participants were randomly assigned to a symptom voice diary intervention group (combining the diary tool with enhanced professional attention) or a usual care control group. Outcomes were self-reported at baseline, four weeks, and eight weeks, with data collected by a blinded research assistant. A modified intention-to-treat (mITT) approach and Generalized Estimating Equation (GEE) models were utilized for longitudinal analysis. RESULTS: Of 70 enrolled patients, 67 were included in the mITT analysis. The GEE omnibus tests revealed statistically significant between-group main effects favoring the intervention for the primary outcome of anxiety (Wald χ2 = 22.681, p < .001), as well as secondary outcomes including depression (Wald χ2 = 9.224, p = .002), health-related quality of life (Wald χ2 = 12.890, p < .001), general self-management (Wald χ2 = 6.366, p = .012), and psychological distress (Wald χ2 = 6.413, p = .011). While 81.3% of intervention completers found the program helpful and not burdensome, only 34.4% expressed the intention to continue using the diary independently after the intervention. CONCLUSIONS: The multicomponent symptom voice diary intervention demonstrated significant short-term efficacy in improving psychological and self-management outcomes in adults with acute leukemia. Future large-scale, attention-matched trials are needed to isolate the diary-specific effects and develop strategies for long-term sustainability. TRIAL REGISTRATION: Registered in the China Clinical Trial Registry on 16 February 2023 (ChiCTR2300068363).