Clinical trial · Interventional
Behavioral Activation for Cancer-Related Fatigue After Breast Cancer Surgery
Behavioral Activation for Cancer-Related Fatigue After Breast Cancer Surgery: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer-related Fatigue | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Activation | Behavioral | — | UNRESOLVED |
| Care as Usual | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Behavioral Activation Plus Care as Usual
- description
- Participants received eight weekly individual behavioral activation sessions over 8 weeks in addition to care as usual. Each session lasted approximately 15-30 minutes and included activity monitoring, values-based goal setting, graded activity scheduling, identification of inactivity and avoidance patterns, review of barriers, and maintenance planning.
- interventionNames
- Behavioral: Behavioral Activation
- type
- OTHER
- label
- Care as Usual
- description
- Participants received routine oncology care and health education, including disease-related information, diet and rest guidance, medication adherence counseling, management of treatment-related symptoms, rehabilitation guidance, and routine follow-up. No structured behavioral activation or standardized psychotherapy was provided.
- interventionNames
- Other: Care as Usual
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available