Breast Neoplasm FemaleNCT06412107
Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors
A study testing True acupressure in people with Breast Neoplasm Female and Symptom Cluster, run by Charles Darwin University at 2 sites in China.
Trial summary
This study is designed following the updated Medical Research Council (MRC) Framework for Developing and Evaluating Complex Interventions. The goal of this randomized controlled trial (RCT) is to evaluate the effects, safety, and cost-effectiveness of an evidence-based somatic acupressure (SA) intervention on the… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasm Female, Symptom Cluster
- What is being tested?
- True acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesChina
- Study dates
- 20 May 2024to 15 Jul 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with early-stage female BC without distant metastases (from stage I to IIIa).
- Have experienced at least moderate FSDSC with a score of ≥4 on an 0-10 point Numeric Rating Scale (0= 'no symptom',10= 'worst symptom') for fatigue, sleep disturbance and depression during the past month.
- Had completed chemotherapy for at least one month and up to three years (to capture persistent symptoms)
- Have no scheduled chemotherapy or radiotherapy during the study.
- Be willing to participate in this study and consent in writing.
Who cannot join
- Currently using pharmaceutical drugs (e.g., antidepressant medications or hypnotics) to treat symptoms of fatigue, sleep disturbance, or depression.
- Inability (or difficulty) in following the study procedures and instructions due to being extremely weak and/or cognitively impaired.
- Received any type of somatic acupressure interventions during the past six months.
- Currently involved in any other studies.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou
About this study
Official title: Somatic Acupressure on Fatigue-sleep Disturbance-depression Symptom Cluster in Breast Cancer Survivors: a Phase III Randomised Controlled Trial
This study is designed following the updated Medical Research Council (MRC) Framework for Developing and Evaluating Complex Interventions. The goal of this randomized controlled trial (RCT) is to evaluate the effects, safety, and cost-effectiveness of an evidence-based somatic acupressure (SA) intervention on the fatigue-sleep disturbance-depression symptom cluster and quality of life among breast cancer survivors.
Read the detailed description
Fatigue, sleep disturbance, and depression commonly co-occur in breast cancer (BC) survivors, forming a significant cluster known as the fatigue-sleep disturbance-depression symptom cluster (FSDSC). The FSDSC correlates notably with decreased everyday functioning and quality of life (QoL). Currently, there are no targeted pharmacological interventions available for alleviating the FSDSC in BC survivors. Additionally, concerns arise regarding the risks of drug-related adverse events and potential interactions with ongoing antineoplastic regimens when relying solely on pharmacological treatments. Consequently, nonpharmacological adjunct interventions have emerged as an alternative method. Somatic acupressure (SA) presents a promising nonpharmacological intervention for managing the FSDSC due to its advantages, including self-administration with minimal effort and time, lower cost, good tolerability, and minimal instruction required from clinical staff. However, the effectiveness of SA in improving the FSDSC in BC survivors remains uncertain. The proposed study follows the Medical Research Council (MRC) Framework for Developing and Evaluating Complex Intervention (the MRC Framework) to develop an evidence-based SA protocol to help with the better management of the FSDSC in BC survivors. The first phase identified and validated the most effective acupoint formula with the optimal SA duration and frequency based on multiple evidence bases. Subsequently, a well-designed phase II randomized controlled trial (RCT) was conducted. It demonstrated the feasibility of an evidence-based SA intervention protocol and its potentially positive effects on the FSDSC in BC survivors. The encouraging results, therefore, warrant further investigation through a large-scale RCT to ascertain the effects of SA on the FSDSC among BC survivors. The whole program is designed following the MRC Framework. Hence, the current study aims to evaluate the effects, safety, and cost-effectiveness of the SA protocol for managing the FSDSC in BC survivors through a phase III RCT.
- Conditions
- Breast Neoplasm Female, Symptom Cluster
- Being tested
- True acupressure, Sham acupressure, Usual care
- Keywords
- cancer, acupressure, fatigue, depression, insomnia
- Medical subject headings
- Syndrome, Neoplasms, Fatigue, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True acupressureOther
Participants will receive a 7-week true self-acupressure practice and a 12-week follow-up.
Sham acupressureOther
Participants will receive a 7-week sham self-acupressure practice and a 12-week follow-up.
Usual careOther
Routine methods of treatment and care along with an updated education booklet.
| Study group | Role | What they receive |
|---|---|---|
| True acupressure group | Experimental | True self-acupressure plus routine methods of treatment and care. Receives: Other: True acupressure; Other: Usual care |
| Sham acupressure group | Sham comparator | Same dose as the true acupressure group but on the sham acupoints plus routine methods of treatment and care. Receives: Other: Sham acupressure; Other: Usual care |
| Usual care group | Other | Routine methods of treatment and care. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
The Brief Fatigue Inventory (BFI; 9 items) will be used to measure the participants' fatigue, with 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." The global score for the BFI is calculated as the mean value of these 9 items. A higher score indicates greater severity of fatigue.
Measured: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Sleep disturbance
The Pittsburgh Sleep Quality Index (PSQI; 19 items) will be used to assess sleep disturbance. A global (total) score is obtained from the sum of the seven component scores, with a possible range of 0 to 21 points. A higher total score indicates poorer sleep quality.
Measured: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Depression
The Hospital Anxiety and Depression Scale-Depression (HADS-D; 7 items; score range 0-21) will be used for evaluating depression. A higher score indicating greater severity of depression
Measured: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Symptom cluster assessment: fatigue
The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess fatigue.
Measured: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Symptom cluster assessment: sleep disturbance
The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess sleep disturbance.
Measured: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Symptom cluster assessment: depression
The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess depression.
Measured: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Secondary outcomes (3)
Patients' Quality of life
The Functional Assessment of Cancer Therapy-Breast (FACT-B; 37 items) will be used for assessing the Patients' Quality of life. A summing-up of each FACT-B subscale creates the FACT-B total score, ranging from 0 to 148. A higher score indicates a better Quality of life.
Measured: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Safety: adverse events
Adverse events will be collected through regular contact between the participant and the research assistant across the intervention period.
Measured: The adverse event will be assessed once it occurs during the study period, from the baseline to the end of 7 weeks.
Economic evaluation
A within-trial economic evaluation will be conducted whereby clinical outcomes (fatigue-sleep disturbance-depression symptom cluster and quality of life) and cost data will be compared between the true intervention group and the usual care group over 19 weeks. Data on economic-related resource use will be captured using a bespoke questionnaire over 19 weeks from randomization.
Measured: Weekly data collected across the 19 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start20 May 2024
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Darwin University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Zunyi Medical University, Zunyi Medical College, University of Southern Queensland
- Responsible party
- Sponsor
- Investigators
- Tao Wang, PhD, Principal investigator, University of Southern Queensland; Charles Darwin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412107
- Sponsor's protocol ID
- H22110; ETH2025-0294
- Status last verified
- Jul 2025
- First submitted
- 26 Feb 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As required by the Human Research Ethics Committee at the study sites, IPD will not be shared with other researchers. Only de-identified, aggregated group data will be used for the purposes of this study
Publications
Li M, Kwok WH, Wang T, Deng R, Wang H, Yao L, Deravin L, Yang L, Tian X, Tan JB. Effects of self-acupressure on the fatigue-sleep disturbance-depression symptom cluster in breast cancer survivors: a phase III randomised controlled trial. Support Care Cancer. 2026 Sep 17;34(10):981. doi: 10.1007/s00520-026-11155-2.
PubMed 42749858Li M, Wang T, Liu XL, Deng RL, Kwok WH, Yao LQ, Tan JB. Somatic acupressure for the management of the fatigue-sleep disturbance-depression symptom cluster in breast cancer survivors: a study protocol for a phase III randomised controlled trial. BMJ Open. 2025 Mar 3;15(3):e089515. doi: 10.1136/bmjopen-2024-089515.
PubMed 40032405
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatic Acupressure on Fatigue-sleep Disturbance-depression Symptom Cluster in Breast Cancer Survivors: a Phase III Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06412107
- Acronym / sponsor ID
- H22110; ETH2025-0294
- Conditions
- Breast Neoplasm Female, Symptom Cluster
- Keywords
- cancer, acupressure, fatigue, depression, insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Charles Darwin UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Zunyi Medical University, Zunyi Medical College, University of Southern Queensland
- Study start
- 20 May 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 14 May 2024 (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.
This study is designed following the updated Medical Research Council (MRC) Framework for Developing and Evaluating Complex Interventions. The goal of this randomized controlled trial (RCT) is to evaluate the effects, safety, and cost-effectiveness of an evidence-based somatic acupressure (SA) intervention on the fatigue-sleep disturbance-depression symptom cluster and quality of life among breast cancer survivors.
Detailed description
Fatigue, sleep disturbance, and depression commonly co-occur in breast cancer (BC) survivors, forming a significant cluster known as the fatigue-sleep disturbance-depression symptom cluster (FSDSC). The FSDSC correlates notably with decreased everyday functioning and quality of life (QoL). Currently, there are no targeted pharmacological interventions available for alleviating the FSDSC in BC survivors. Additionally, concerns arise regarding the risks of drug-related adverse events and potential interactions with ongoing antineoplastic regimens when relying solely on pharmacological treatments. Consequently, nonpharmacological adjunct interventions have emerged as an alternative method. Somatic acupressure (SA) presents a promising nonpharmacological intervention for managing the FSDSC due to its advantages, including self-administration with minimal effort and time, lower cost, good tolerability, and minimal instruction required from clinical staff. However, the effectiveness of SA in improving the FSDSC in BC survivors remains uncertain. The proposed study follows the Medical Research Council (MRC) Framework for Developing and Evaluating Complex Intervention (the MRC Framework) to develop an evidence-based SA protocol to help with the better management of the FSDSC in BC survivors. The first phase identified and validated the most effective acupoint formula with the optimal SA duration and frequency based on multiple evidence bases. Subsequently, a well-designed phase II randomized controlled trial (RCT) was conducted. It demonstrated the feasibility of an evidence-based SA intervention protocol and its potentially positive effects on the FSDSC in BC survivors. The encouraging results, therefore, warrant further investigation through a large-scale RCT to ascertain the effects of SA on the FSDSC among BC survivors. The whole program is designed following the MRC Framework. Hence, the current study aims to evaluate the effects, safety, and cost-effectiveness of the SA protocol for managing the FSDSC in BC survivors through a phase III RCT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| True acupressure group | Experimental | Other: True acupressure, Other: Usual careTrue self-acupressure plus routine methods of treatment and care. |
| Sham acupressure group | Sham comparator | Other: Sham acupressure, Other: Usual careSame dose as the true acupressure group but on the sham acupoints plus routine methods of treatment and care. |
| Usual care group | Other | Other: Usual careRoutine methods of treatment and care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with early-stage female BC without distant metastases (from stage I to IIIa).
- Have experienced at least moderate FSDSC with a score of ≥4 on an 0-10 point Numeric Rating Scale (0= 'no symptom',10= 'worst symptom') for fatigue, sleep disturbance and depression during the past month.
- Had completed chemotherapy for at least one month and up to three years (to capture persistent symptoms)
- Have no scheduled chemotherapy or radiotherapy during the study.
- Be willing to participate in this study and consent in writing.
Key exclusion criteria (4 listed)
- Currently using pharmaceutical drugs (e.g., antidepressant medications or hypnotics) to treat symptoms of fatigue, sleep disturbance, or depression.
- Inability (or difficulty) in following the study procedures and instructions due to being extremely weak and/or cognitively impaired.
- Received any type of somatic acupressure interventions during the past six months.
- Currently involved in any other studies.
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 |
|---|---|---|
| True acupressureParticipants will receive a 7-week true self-acupressure practice and a 12-week follow-up. | Other | True acupressure group |
| Sham acupressureParticipants will receive a 7-week sham self-acupressure practice and a 12-week follow-up. | Other | Sham acupressure group |
| Usual careRoutine methods of treatment and care along with an updated education booklet. | Other | Sham acupressure group, True acupressure group, Usual care group |
Primary outcome
Fatigue
Time frame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
The Brief Fatigue Inventory (BFI; 9 items) will be used to measure the participants' fatigue, with 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." The global score for the BFI is calculated as the mean value of these 9 items. A higher score indicates greater severity of fatigue.
Sleep disturbance
Time frame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
The Pittsburgh Sleep Quality Index (PSQI; 19 items) will be used to assess sleep disturbance. A global (total) score is obtained from the sum of the seven component scores, with a possible range of 0 to 21 points. A higher total score indicates poorer sleep quality.
Depression
Time frame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
The Hospital Anxiety and Depression Scale-Depression (HADS-D; 7 items; score range 0-21) will be used for evaluating depression. A higher score indicating greater severity of depression
Symptom cluster assessment: fatigue
Time frame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess fatigue.
Symptom cluster assessment: sleep disturbance
Time frame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess sleep disturbance.
Symptom cluster assessment: depression
Time frame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess depression.
3 secondary outcomes
Patients' Quality of life
Time frame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)
Safety: adverse events
Time frame: The adverse event will be assessed once it occurs during the study period, from the baseline to the end of 7 weeks.
Economic evaluation
Time frame: Weekly data collected across the 19 weeks.
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 25 Jul 2025.
- Derived from this study: PubMed 42749858Li M, Kwok WH, Wang T, Deng R, Wang H, Yao L, Deravin L, Yang L, Tian X, Tan JB. Effects of self-acupressure on the fatigue-sleep disturbance-depression symptom cluster in breast cancer survivors: a phase III randomised controlled trial. Support Care Cancer. 2026 Sep 17;34(10):981. doi: 10.1007/s00520-026-11155-2.
- Derived from this study: PubMed 40032405Li M, Wang T, Liu XL, Deng RL, Kwok WH, Yao LQ, Tan JB. Somatic acupressure for the management of the fatigue-sleep disturbance-depression symptom cluster in breast cancer survivors: a study protocol for a phase III randomised controlled trial. BMJ Open. 2025 Mar 3;15(3):e089515. doi: 10.1136/bmjopen-2024-089515.
- Individual participant dataSharing planned: No. As required by the Human Research Ethics Committee at the study sites, IPD will not be shared with other researchers. Only de-identified, aggregated group data will be used for the purposes of this study
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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.
Tao Wang, PhD principal investigator
University of Southern Queensland; Charles Darwin University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing True acupressure in people with Breast Neoplasm Female and Symptom Cluster, run by Charles Darwin University at 2 sites 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 5 inclusion and 4 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Fatigue (time frame: Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06412107, which also lists 2 linked publications.
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 25 Jul 2025.