NCT04118140

Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients

Development and Preliminary Evaluation of an Evidence-based Somatic Acupressure Protocol for the Self-management of Symptom Cluster of Fatigue, Insomnia and Depression in Breast Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Charles Darwin University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Cancer

Interventions

Type	Name	Description
OTHER	Somatic Acupressure	7-week self-acupressure plus usual care (an education booklet)
OTHER	Sham acupressure	Same dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet)
OTHER	Usual care	Usual care only (an education booklet)

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-05-17
• Completion: 2022-07-20
• First posted: 2019-10-08
• Last updated: 2022-07-21

Locations

1 site across 1 country: China