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).