Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors

Charles Darwin University

Status: Completed

Conditions: Symptom Cluster; Breast Neoplasm Female

Treatments: Other: Sham acupressure; Other: True acupressure; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT06412107

H22110 ETH2025-0294;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 3 patient groups

True acupressure group

Experimental group

Description:

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

Treatment:

Other: Usual care

Other: True acupressure

Sham acupressure group

Sham Comparator group

Description:

Same dose as the true acupressure group but on the sham acupoints plus routine methods of treatment and care.

Treatment:

Other: Usual care

Other: Sham acupressure

Usual care group

Other group

Description:

Routine methods of treatment and care.

Treatment:

Other: Usual care