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Sponsor: Huaidong Cheng
Conditions: Breast Cancer；Cancer-Related Fatigue
Interventions: Behavioral Activation, Care as Usual
Countries: China
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).
Sex: FEMALE
Age: 18 Years to 65 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Shenzhen, Guangdong, China