Behavioral Activation for Cancer-Related Fatigue After Breast Cancer Surgery

NCT07799909 | Completed

• 1 other identifier: NYSZYYEC2026K126R002
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer; Cancer-related Fatigue

Keywords

Behavioral Activation; Heart Rate Variability; Systemic Inflammation; Cancer Recovery; Supportive therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 4, and Week 8; primary endpoint at Week 8

Secondary Outcomes (10)

• Change in Anxiety Symptoms

  Baseline, Week 4, and Week 8

• Change in Depressive Symptoms

  Baseline, Week 4, and Week 8

• Change in Global Health Status/Quality of Life

  Baseline, Week 4, and Week 8

• Change in RMSSD

  Baseline, Week 4, and Week 8

• Change in SDNN

  Baseline, Week 4, and Week 8

Study Arms (2)

Behavioral Activation Plus Care as Usual

EXPERIMENTAL

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.

Behavioral: Behavioral Activation

Care as Usual

OTHER

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.

Other: Care as Usual

Interventions

Behavioral Activation BEHAVIORAL

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.

Behavioral Activation Plus Care as Usual

Care as Usual OTHER

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

Care as Usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huaidong Cheng: lead

Study Sites (1)

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 518100, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 2, 2026
• Study Start: May 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: De-identified individual participant data and supporting information will be available after publication of the primary trial results, subject to institutional approval and applicable ethical and privacy requirements.
• Access Criteria: De-identified individual participant data may be provided to qualified researchers upon reasonable request for a scientifically valid purpose. Requests should be submitted to the corresponding investigator and will be reviewed subject to institutional approval and applicable ethical and privacy requirements.

Locations

CN (1)