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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
114
A structured 8-week behavioral intervention consisting of eight weekly individual sessions of approximately 15-30 minutes. Core components included activity monitoring, values-based goal setting, graded activity scheduling, identification of inactivity and avoidance patterns, review of barriers, and maintenance planning.
Routine oncology care and health education provided according to clinical needs and institutional practice.
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China
Change in Cancer-Related Fatigue Measured by the Revised Piper Fatigue Scale (PFS-R)
Cancer-related fatigue was assessed using the Revised Piper Fatigue Scale (PFS-R). The item mean score ranges from 0 to 10, with higher scores indicating greater fatigue. The primary endpoint was the between-group difference in change in PFS-R score from baseline to Week 8. PFS-R was also assessed at Week 4.
Time frame: Baseline, Week 4, and Week 8; primary endpoint at Week 8
Change in Anxiety Symptoms
Anxiety was assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A), ranging from 0 to 21, with higher scores indicating greater anxiety.
Time frame: Baseline, Week 4, and Week 8
Change in Depressive Symptoms
Depressive symptoms were assessed using the Hospital Anxiety and Depression Scale-Depression subscale (HADS-D), ranging from 0 to 21, with higher scores indicating greater depressive symptoms.
Time frame: Baseline, Week 4, and Week 8
Change in Global Health Status/Quality of Life
Global health status/quality of life was assessed using the EORTC QLQ-C30. Scores are transformed to a 0-100 scale, with higher global health status/quality of life scores indicating better quality of life.
Time frame: Baseline, Week 4, and Week 8
Change in RMSSD
RMSSD was derived from resting heart rate variability recordings and expressed in milliseconds.
Time frame: Baseline, Week 4, and Week 8
Change in SDNN
SDNN was derived from resting heart rate variability recordings and expressed in milliseconds.
Time frame: Baseline, Week 4, and Week 8
Change in Low-Frequency Heart Rate Variability Power
Low-frequency heart rate variability power was derived from resting recordings.
Time frame: Baseline, Week 4, and Week 8
Change in High-Frequency Heart Rate Variability Power
High-frequency heart rate variability power was derived from resting recordings.
Time frame: Baseline, Week 4, and Week 8
Change in LF/HF Ratio
The ratio of low-frequency to high-frequency heart rate variability power was calculated from resting recordings.
Time frame: Baseline, Week 4, and Week 8
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
NLR was calculated as the absolute neutrophil count divided by the absolute lymphocyte count from complete blood counts obtained at each assessment.
Time frame: Baseline, Week 4, and Week 8
Change in Systemic Immune-Inflammation Index (SII)
SII was calculated as platelet count × neutrophil count / lymphocyte count from complete blood counts obtained at each assessment.
Time frame: Baseline, Week 4, and Week 8
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