Breast Cancer, Cancer-related Fatigue
Conditions
Keywords
Behavioral Activation, Heart Rate Variability, Systemic Inflammation, Cancer Recovery, Supportive therapy
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALBehavioral Activation
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.
OTHERCare as Usual
Routine oncology care and health education provided according to clinical needs and institutional practice.
Sponsors
Huaidong Cheng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and interventionists could not be masked because of the behavioral nature of the intervention. Outcome assessors conducting the Week 4 and Week 8 assessments were unaware of treatment allocation.
Intervention model description
Participants were randomized in a 1:1 ratio to behavioral activation plus care as usual or care as usual alone and were followed for 8 weeks.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cancer-Related Fatigue Measured by the Revised Piper Fatigue Scale (PFS-R) | Baseline, Week 4, and Week 8; primary endpoint at Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Symptoms | Baseline, Week 4, and Week 8 | 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. |
| Change in Depressive Symptoms | Baseline, Week 4, and Week 8 | 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. |
| Change in Global Health Status/Quality of Life | Baseline, Week 4, and Week 8 | 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. |
| Change in RMSSD | Baseline, Week 4, and Week 8 | RMSSD was derived from resting heart rate variability recordings and expressed in milliseconds. |
| Change in SDNN | Baseline, Week 4, and Week 8 | SDNN was derived from resting heart rate variability recordings and expressed in milliseconds. |
| Change in Low-Frequency Heart Rate Variability Power | Baseline, Week 4, and Week 8 | Low-frequency heart rate variability power was derived from resting recordings. |
| Change in High-Frequency Heart Rate Variability Power | Baseline, Week 4, and Week 8 | High-frequency heart rate variability power was derived from resting recordings. |
| Change in LF/HF Ratio | Baseline, Week 4, and Week 8 | The ratio of low-frequency to high-frequency heart rate variability power was calculated from resting recordings. |
| Change in Neutrophil-to-Lymphocyte Ratio (NLR) | Baseline, Week 4, and Week 8 | NLR was calculated as the absolute neutrophil count divided by the absolute lymphocyte count from complete blood counts obtained at each assessment. |
| Change in Systemic Immune-Inflammation Index (SII) | Baseline, Week 4, and Week 8 | SII was calculated as platelet count × neutrophil count / lymphocyte count from complete blood counts obtained at each assessment. |
Countries
China
Outcome results
None listed