Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients

Charles Darwin University

Status: Completed

Conditions: Cancer

Treatments: Other: Somatic Acupressure; Other: Sham acupressure; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04118140

H19017

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 51 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 3 patient groups

True SA (Somatic Acupressure ) group

Experimental group

Description:

Receiving true somatic acupressure+usual care

Treatment:

Other: Usual care

Other: Somatic Acupressure

Sham SA group

Sham Comparator group

Description:

Receiving sham somatic acupressure+usual care

Treatment:

Other: Sham acupressure

Other: Usual care

Usual care group

Other group

Description:

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

Treatment:

Other: Usual care