Breast CancerNCT07799909
Behavioral Activation for Cancer-Related Fatigue After Breast Cancer Surgery
A study testing Behavioral Activation and Care as Usual in people with Breast Cancer and Cancer-related Fatigue, run by Huaidong Cheng at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Cancer-related Fatigue
- What is being tested?
- Behavioral Activation and Care as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 518100
About this study
Official title: Behavioral Activation for Cancer-Related Fatigue After Breast Cancer Surgery: A Randomized Controlled Trial
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).
Read the 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.
- Conditions
- Breast Cancer, Cancer-related Fatigue
- Being tested
- Behavioral Activation, Care as Usual
- Keywords
- Behavioral Activation, Heart Rate Variability, Systemic Inflammation, Cancer Recovery, Supportive therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
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.
Care as UsualOther
Routine oncology care and health education provided according to clinical needs and institutional practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Care as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4, and Week 8; primary endpoint at Week 8
Secondary outcomes (10)
Change in Anxiety Symptoms
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.
Measured: Baseline, Week 4, and Week 8
Change in Depressive Symptoms
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.
Measured: Baseline, Week 4, and Week 8
Change in Global Health Status/Quality of Life
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.
Measured: Baseline, Week 4, and Week 8
Change in RMSSD
RMSSD was derived from resting heart rate variability recordings and expressed in milliseconds.
Measured: Baseline, Week 4, and Week 8
Change in SDNN
SDNN was derived from resting heart rate variability recordings and expressed in milliseconds.
Measured: Baseline, Week 4, and Week 8
Change in Low-Frequency Heart Rate Variability Power
Low-frequency heart rate variability power was derived from resting recordings.
Measured: Baseline, Week 4, and Week 8
Change in High-Frequency Heart Rate Variability Power
High-frequency heart rate variability power was derived from resting recordings.
Measured: Baseline, Week 4, and Week 8
Change in LF/HF Ratio
The ratio of low-frequency to high-frequency heart rate variability power was calculated from resting recordings.
Measured: Baseline, Week 4, and Week 8
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
NLR was calculated as the absolute neutrophil count divided by the absolute lymphocyte count from complete blood counts obtained at each assessment.
Measured: Baseline, Week 4, and Week 8
Change in Systemic Immune-Inflammation Index (SII)
SII was calculated as platelet count × neutrophil count / lymphocyte count from complete blood counts obtained at each assessment.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 May 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huaidong Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huaidong Cheng, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799909
- Sponsor's protocol ID
- NYSZYYEC2026K126R002
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results may be shared upon reasonable request, subject to appropriate institutional approval and applicable ethical and privacy requirements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation for Cancer-Related Fatigue After Breast Cancer Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07799909
- Acronym / sponsor ID
- NYSZYYEC2026K126R002
- Conditions
- Breast Cancer, Cancer-related Fatigue
- Keywords
- Behavioral Activation, Heart Rate Variability, Systemic Inflammation, Cancer Recovery, Supportive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Huaidong ChengUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation Plus Care as Usual | Experimental | Behavioral: Behavioral ActivationParticipants 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. |
| Care as Usual | Other | Other: Care as UsualParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral ActivationA 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. | Behavioural | Behavioral Activation Plus Care as Usual |
| Care as UsualRoutine oncology care and health education provided according to clinical needs and institutional practice. | Other | Care as Usual |
Primary outcome
Change in Cancer-Related Fatigue Measured by the Revised Piper Fatigue Scale (PFS-R)
Time frame: 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.
10 secondary outcomes
Change in Anxiety Symptoms
Time frame: Baseline, Week 4, and Week 8
Change in Depressive Symptoms
Time frame: Baseline, Week 4, and Week 8
Change in Global Health Status/Quality of Life
Time frame: Baseline, Week 4, and Week 8
Change in RMSSD
Time frame: Baseline, Week 4, and Week 8
Change in SDNN
Time frame: Baseline, Week 4, and Week 8
Change in Low-Frequency Heart Rate Variability Power
Time frame: Baseline, Week 4, and Week 8
Change in High-Frequency Heart Rate Variability Power
Time frame: Baseline, Week 4, and Week 8
Change in LF/HF Ratio
Time frame: Baseline, Week 4, and Week 8
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: Baseline, Week 4, and Week 8
Change in Systemic Immune-Inflammation Index (SII)
Time frame: Baseline, Week 4, and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results may be shared upon reasonable request, subject to appropriate institutional approval and applicable ethical and privacy requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation and Care as Usual in people with Breast Cancer and Cancer-related Fatigue, run by Huaidong Cheng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cancer-Related Fatigue Measured by the Revised Piper Fatigue Scale (PFS-R) (time frame: Baseline, Week 4, and Week 8; primary endpoint at Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.