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 among women with breast cancer in mainland China during and after radiotherapy using linear mixed models analyses.
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 a control group (standard care). Primary outcomes were trajectories of change on the Self-rated Anxiety Scale (SAS) and Self-rated Depression Scale (SDS) from baseline (T0) to mid-radiotherapy (T1), to the 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 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 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), indicating a minimal clinically important difference.
Conclusions
A 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- months of follow-up. Inclusion of this intervention as part of routine radiotherapy care of breast cancer patients in China appears feasible and effective.
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