Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients

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

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-07-20

Brief Summary

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Using a robust research method following the MRC Framework, the proposed study will develop and test an evidence-based complementary health intervention to help breast cancer patients manage the fatigue-sleep disturbance-depression symptom cluster.

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Detailed Description

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The fatigue-sleep disturbance-depression (FSD) symptom cluster is one of the most common symptom clusters in breast cancer (BC) patients, which can significantly deteriorate patients' functional status and quality of life. Since symptom cluster management has been unsatisfactory by using pharmacological treatments alone, the use of non-pharmacological adjuvant approaches has therefore been recommended. Being an important modality of acupoint stimulation, somatic acupressure (SA) can be a promising non-pharmacological intervention given its potential benefits for cancer symptom alleviation and its convenience for self-practice without increasing patients' physical and financial burden. However, current research on acupoint stimulation for cancer symptom management has been mainly focusing on individual symptom, and intervention protocols have been found significantly varied in intervention dosages and acupoint formula without a standardised protocol developed via a rigorous evidence-based research approach. The proposed study therefore 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 a better management of the FSD symptom cluster in BC. The first two phases of the MRC Framework will be included in this study. The first phase utilizes an evidence-based method to comprehensively review all available research evidence on acupoint-stimulation for cancer-related fatigue, sleep disturbance and depression, and further identify the most effective acupoint formula with the optimal SA duration and frequency. A preliminary SA protocol will then be developed based on the current research evidence and relevant theories and guidelines of acupoint stimulation. A content validity study will be conducted then to examine the content validity of the SA protocol via an expert panel. In the second phase, a feasibility randomized controlled trial (RCT) will be conducted to examine the acceptability of the SA protocol, pilot the methodological procedure of the clinical trial and preliminarily examine the effects of SA on the FSD symptom cluster in BC. Semi-structured interviews will be conducted afterwards to explore patients' experiences of participating in the study and receiving the SA.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

This study can perform a partial blind design for participants in the true and sham intervention 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 SA (Somatic Acupressure ) group

Receiving true somatic acupressure+usual care

Group Type EXPERIMENTAL

Somatic Acupressure

Intervention Type OTHER

7-week self-acupressure plus usual care (an education booklet)

Usual care

Intervention Type OTHER

Usual care only (an education booklet)

Sham SA group

Receiving sham somatic acupressure+usual care

Group Type SHAM_COMPARATOR

Sham acupressure

Intervention Type OTHER

Same dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet)

Usual care

Intervention Type OTHER

Usual care only (an education booklet)

Usual care group

Receiving usual care only (an education booklet regarding knowledge of BC and FSD symptom cluster management advice)

Group Type OTHER

Usual care

Intervention Type OTHER

Usual care only (an education booklet)

Interventions

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Somatic Acupressure

7-week self-acupressure plus usual care (an education booklet)

Intervention Type OTHER

Sham acupressure

Same dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet)

Intervention Type OTHER

Usual care

Usual care only (an education booklet)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. BC stage I to IIIa;
2. have experienced at least a moderate level of the FSD symptom cluster, with a score of 4 or above on a 10-point numeric rating scale, from "0 (no symptom)" to "10 (worst symptom)", for each symptom during the past one month;
3. have completed adjuvant chemotherapy for at least one month and up to three years;
4. have not scheduled chemotherapy and radiotherapy during the whole study period;
5. willing to participate in the RCT and provide written informed consent.

Exclusion Criteria

1. presently taking pharmaceutical agents to treat fatigue, sleep disturbance or depression, such as antidepressant medications, psychostimulants, or hypnotics;
2. extremely weak and/or have cognitive impairment which make them unable (or difficult) to follow the study procedures and instructions;
3. having the experience of any types of SAS treatment during the past six months;
4. presently participating in any other research projects.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes