Abstract
Objective
Breast cancer patients undergoing radiotherapy frequently experience psychological distress that negatively impacts treatment outcomes and quality of life. Evidence for structured psychological interventions during radiotherapy remains limited. This study evaluated the longitudinal effects of a structured education plus entertainment therapy intervention on anxiety, depression, and quality of life in mainland China breast cancer patients during and after radiotherapy using linear mixed model analysis.
Methods
This single-center, parallel-group, assessor-blinded randomized controlled trial enrolled 280 female breast cancer patients (aged 18-75 years) receiving adjuvant radiotherapy. Participants were randomized 1:1 to intervention (structured education plus entertainment therapy) or control (standard care). Primary outcomes were Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) trajectories assessed at baseline (T0), mid-radiotherapy (T1), end of radiotherapy (T2), and 1, 3, and 6 months post-radiotherapy (T3-T5). Secondary outcomes included quality of life (EORTC QLQ-C30/BR23 domains), acute toxicity (CTCAE v5.0), and adherence. Linear mixed models with group × time interaction assessed intervention effects.
Results
Of 280 randomized patients, 252 (90%) completed the T5 assessment. The intervention group showed significantly improved SAS trajectory (group × time interaction β = −1.82, 95% CI: −3.14 to −0.50, P = 0.007) with estimated marginal mean difference of −3.45 points at T5. SDS trajectory improvement was marginally significant (β = −1.56, 95% CI: −3.12 to 0.01, P = 0.051). Minimal clinically important difference (MCID, ≥0.5 SD improvement) was achieved by 48.6% vs 31.4% for anxiety (P = 0.004) and 42.1% vs 29.3% for depression (P = 0.027) for intervention and control groups, respectively. Global health status improved significantly (β = 4.23, P < 0.001). Grade ≥2 radiation dermatitis occurred in 37.1% vs 48.6% (P = 0.055) in intervention and control groups, respectively. High adherence (≥70% sessions) in 72.1% of intervention patients was associated with greater benefits.
Conclusions
The structured education plus entertainment therapy intervention demonstrated small-to-moderate clinically meaningful improvements in anxiety, depression, and quality of life during radiotherapy, with effects persisting through 6-month follow-up. Implementation into routine radiotherapy care of breast cancer patients in China appears feasible and effective.
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