Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2025-07-15

Brief Summary

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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.

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Detailed Description

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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

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Breast Neoplasm Female Symptom Cluster

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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True acupressure group

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

Group Type EXPERIMENTAL

True acupressure

Intervention Type OTHER

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

Usual care

Intervention Type OTHER

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

Sham acupressure group

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

Group Type SHAM_COMPARATOR

Sham acupressure

Intervention Type OTHER

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

Usual care

Intervention Type OTHER

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

Usual care group

Routine methods of treatment and care.

Group Type OTHER

Usual care

Intervention Type OTHER

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

Interventions

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True acupressure

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

Intervention Type OTHER

Sham acupressure

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

Intervention Type OTHER

Usual care

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes