Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Depression

Breast Neoplasms

Syndrome

Fatigue

Depressive Disorder

Receiving true somatic acupressure+usual care

Receiving sham somatic acupressure+usual care

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

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

Somatic Acupressure

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

Sham acupressure

Usual care

Jing-Yu (Benjamin) Tan, PhD RN

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.

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.

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.

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

Eligibility rate as assessed by (the number of eligible participants / number of participants screened) x 100%

Recruitment rate as assessed by (the number of participants who participated in the study / number of eligible participants) x 100%

Retention rate as assessed by (the number of participants who completed the study / number of participants who enrolled in) x 100%

Attrition rate as assessed by (the number of participants who dropped out after the randomization / number of participants who enrolled in) x 100%

Feasibility of subject recruitment assessed by interviewing the participants' feedback regarding why they discontinued this study

Time period from the recruitment of first participants to the last patient: assessed by months

The number of days that the participants perform the SA interventions, where the scheduled sessions should be 7 weeks of daily acupressure

Duration of each time (minutes) of acupressure where the scheduled time per session should be around 36 minutes

Participants' feedback and satisfaction with the SA intervention assessed by a self-designed feedback form and follow-up semi-structured interviews

Item-level missing value of each questionnaire (%) assessed by the percentage of participants who do not answer any single item

Scale-level missing value of the questionnaire (%) assessed by the percentage of participants who do not answer at least one item in the whole questionnaire

Number of adverse events occur during the intervention

Fatigue measured by the Multidimensional Fatigue Inventory

Insomnia measured by Pittsburgh Sleep Quality Index

Depression measured by Hospital Anxiety and Depression Scale

Measured by the Functional Assessment of Cancer Therapy-Breast Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients	NCT04118140	Cancer	Somatic Acupres... Sham acupressur... Usual care	18 Years -	Charles Darwin University
Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients	NCT04118140	Cancer	Somatic Acupres... Sham acupressur... Usual care	18 Years -	Charles Darwin University
Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients	NCT04118140	Cancer	Somatic Acupres... Sham acupressur... Usual care	18 Years -	Charles Darwin University

Spots Global Cancer Trial Database for somatic acupressure