Clinical trial · Interventional
Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors
Somatic Acupressure on Fatigue-sleep Disturbance-depression Symptom Cluster in Breast Cancer Survivors: a Phase III Randomised Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Female | — | UNRESOLVED | — |
| Symptom Cluster | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sham acupressure | Other | — | UNRESOLVED |
| True acupressure | Other | — | UNRESOLVED |
| Usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- True acupressure group
- description
- True self-acupressure plus routine methods of treatment and care.
- interventionNames
- Other: True acupressure
- Other: Usual care
- type
- SHAM_COMPARATOR
- label
- Sham acupressure group
- description
- Same dose as the true acupressure group but on the sham acupoints plus routine methods of treatment and care.
- interventionNames
- Other: Sham acupressure
- Other: Usual care
- type
- OTHER
- label
- Usual care group
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed with early-stage female BC without distant metastases (from stage I to IIIa). 2. 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. 3. Had completed chemotherapy for at least one month and up to three years (to capture persistent symptoms) 4. Have no scheduled chemotherapy or radiotherapy during the study. 5. Be willing to participate in this study and consent in writing. Exclusion Criteria: 1. Currently using pharmaceutical drugs (e.g., antidepressant medications or hypnotics) to treat symptoms of fatigue, sleep disturbance, or depression. 2. Inability (or difficulty) in following the study procedures and instructions due to being extremely weak and/or cognitively impaired. 3. Received any type of somatic acupressure interventions during the past six months. 4. Currently involved in any other studies.
References
Publications (1)
- DERIVEDLi 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. PMID 40032405