Behavioral Activation for Cancer-Related Fatigue After Breast Cancer Surgery: A Randomized Controlled Trial
Behavioral Activation for Cancer-Related Fatigue After Breast Cancer Surgery: A Randomized Controlled Trial
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).
This was a single-center, assessor-blinded, parallel-group randomized controlled trial conducted at Shenzhen Hospital of Southern Medical University. Eligible participants were women aged 18-65 years with pathologically confirmed stage I-III primary breast cancer who had completed breast cancer surgery, were clinically stable, had a Karnofsky Performance Status score of at least 80, and were able to complete study questionnaires and heart rate variability assessments. Participants could be receiving or have completed adjuvant chemotherapy, radiotherapy, and/or endocrine therapy at enrollment.
Participants assigned to the experimental arm received structured behavioral activation in addition to care as usual. The program comprised eight weekly individual sessions, each lasting approximately 15-30 minutes. Core components included activity monitoring, identification of inactivity and avoidance patterns, values-based goal setting, graded activity scheduling, review of barriers, and maintenance planning. The first session was delivered face to face; subsequent sessions could be delivered face to face, by WeChat audio/video, or by telephone according to clinical and logistical needs.
Participants in the comparator arm received routine oncology care and health education without structured behavioral activation or standardized psychotherapy. Patient-reported outcomes, heart rate variability, and prespecified complete blood count-derived inflammatory indices were assessed longitudinally at baseline, Week 4, and Week 8.
Inclusion Criteria:
Female participants aged 18-65 years. Pathologically confirmed stage I-III primary breast cancer. Completed breast cancer surgery. Clinically stable. Karnofsky Performance Status (KPS) score ≥80. Able to complete study questionnaires and heart rate variability assessments. Participants could be receiving or have completed adjuvant chemotherapy, radiotherapy, and/or endocrine therapy at enrollment.
Exclusion Criteria:
Structured psychotherapy or behavioral therapy within the previous 3 months. Severe psychiatric illness or cognitive impairment. Communication difficulties that would interfere with study participation. Recurrent or metastatic breast cancer. Limited life expectancy. Severe comorbidity or marked frailty that could interfere with activity participation or heart rate variability assessment.
Use of psychotropic or other medications judged by the investigators to substantially affect psychological status or autonomic function.