Can a simple activity plan beat Post-Surgery fatigue in breast cancer?
NCT ID NCT07799909
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This trial tests whether an 8-week behavioral activation program can reduce cancer-related fatigue in women who have had surgery for stage I-III breast cancer. Participants are randomly assigned to receive the program plus usual care, or usual care alone. The study measures fatigue, anxiety, depression, quality of life, and certain blood markers over 8 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Behavioral activation, a structured 8-week program of weekly sessions focusing on activity monitoring, goal setting, and graded activity scheduling
- What this could lead to
- If it works, this program could offer a drug-free way to reduce cancer-related fatigue and improve quality of life for women after breast cancer surgery.
- What could go wrong
- This is a relatively small trial, and the outcome depends on participants sticking with the program. The benefits may not extend beyond the study setting or last long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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114 people
The number who actually took part.
- Started
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May 2025
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 518100, China