Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors

NCT06412107 | Completed DMC

• 1 other identifier: H22110; ETH2025-0294
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief 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 fatigue-sleep disturbance-depression symptom cluster and quality of life among breast cancer survivors.

Conditions

Breast Neoplasm Female; Symptom Cluster

Keywords

cancer; acupressure; fatigue; depression; insomnia

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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

  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.

  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.

  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.

  Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)

Secondary Outcomes (3)

• Patients' Quality of life

  Baseline Assessments (T1); Immediately after completion of the 7-week intervention (T2); 12-week Follow-up (T3)

• Safety: adverse events

  The adverse event will be assessed once it occurs during the study period, from the baseline to the end of 7 weeks.

• Economic evaluation

  Weekly data collected across the 19 weeks.

Study Arms (3)

True acupressure group

EXPERIMENTAL

True self-acupressure plus routine methods of treatment and care.

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.

Other: Sham acupressure; Other: Usual care

Usual care group

OTHER

Routine methods of treatment and care.

Other: Usual care

Interventions

True acupressure OTHER

Participants will receive a 7-week true self-acupressure practice and a 12-week follow-up.

True acupressure group

Sham acupressure OTHER

Participants will receive a 7-week sham self-acupressure practice and a 12-week follow-up.

Sham acupressure group

Usual care OTHER

Routine methods of treatment and care along with an updated education booklet.

Sham acupressure group; True acupressure group; Usual care group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charles Darwin University: lead
• Second Affiliated Hospital of Zunyi Medical University: collaborator
• Zunyi Medical College: collaborator
• University of Southern Queensland: collaborator

Study Sites (2)

The Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Location

The Second Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Location

Related Publications (1)

• Li 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 DERIVED

MeSH Terms

Conditions

Syndrome; Neoplasms; Fatigue; Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Tao Wang, PhD

  University of Southern Queensland; Charles Darwin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study can achieve a partial blind design for participants in the true and sham acupressure groups. Blind of outcome assessment will be also achieved in the true and sham intervention groups as all the questionnaires are patient-reported and the participants themselves will be the outcome assessors. Data analysis will be conducted by an independent statistician who are blinded to the group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: May 14, 2024
• Study Start: May 20, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)