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COMPLETED
NCT07799909
NA

Behavioral Activation for Cancer-Related Fatigue After Breast Cancer Surgery

Sponsor: Huaidong Cheng

View on ClinicalTrials.gov

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).

Official title: Behavioral Activation for Cancer-Related Fatigue After Breast Cancer Surgery: A Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2025-05-01

Completion Date

2025-12-31

Last Updated

2026-09-02

Healthy Volunteers

No

Interventions

BEHAVIORAL

Behavioral 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.

OTHER

Care as Usual

Routine oncology care and health education provided according to clinical needs and institutional practice.

Locations (1)

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, China