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Behavioral Activation for Cancer-Related Fatigue After Breast Cancer Surgery

StatusCompleted
PhaseNot applicable
Started2025-05-01
View on ClinicalTrials.gov ↗
Cancer-related fatigue is common after breast cancer surgery and may persist during adjuvant treatment and early survivorship. This randomized controlled trial evaluated whether an 8-week graded behavioral activation intervention could reduce cancer-related fatigue in women with stage I-III breast cancer after surgery. Participants were randomly assigned in a 1:1 ratio to behavioral activation plus care as usual or care as usual alone. Assessments were conducted at baseline, Week 4, and Week 8. The primary outcome was cancer-related fatigue measured with the revised Piper Fatigue Scale (PFS-R). Secondary outcomes included anxiety, depressive symptoms, global health status/quality of life, and heart rate variability. Prespecified systemic inflammatory biomarkers derived from complete blood counts included the neutrophil-to-lymphocyte ratio (NLR) and systemic immune-inflammation index (SII).
Trial Details
NCT Number NCT07799909
Lead Sponsor Huaidong Cheng
Conditions Breast Cancer；Cancer-Related Fatigue
Enrollment 114 participants
Start Date 2025-05-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-02