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

The Affiliated Hospital Of Southwest Medical University

Charles Darwin University

Nervous System Diseases

Parasomnias

Dyssomnias

Breast Diseases

Skin Diseases

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

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

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

True acupressure

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

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

Meng-Yuan Li, PhDc

Tao Wang, PhD

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.

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.

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.

Somatic Acupressure for Symptom Cluster Management in Breast Cancer Survivors

Somatic Acupressure on Fatigue-sleep Disturbance-depression Symptom Cluster in Breast Cancer Survivors: a Phase III Randomised Controlled Trial

The Brief Fatigue Inventory (BFI; 9 items) will be used to measure the participants' fatigue, with 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." The global score for the BFI is calculated as the mean value of these 9 items. A higher score indicates greater severity of fatigue.

The Pittsburgh Sleep Quality Index (PSQI; 19 items) will be used to assess sleep disturbance. A global (total) score is obtained from the sum of the seven component scores, with a possible range of 0 to 21 points. A higher total score indicates poorer sleep quality.

The Hospital Anxiety and Depression Scale-Depression (HADS-D; 7 items; score range 0-21) will be used for evaluating depression. A higher score indicating greater severity of depression

The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess fatigue.

The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess sleep disturbance.

The 0-10 Numeric Rating Scale (0='no symptom', 10='worst symptom') will be used to assess depression.

The Functional Assessment of Cancer Therapy-Breast (FACT-B; 37 items) will be used for assessing the Patients' Quality of life. A summing-up of each FACT-B subscale creates the FACT-B total score, ranging from 0 to 148. A higher score indicates a better Quality of life.

Adverse events will be collected through regular contact between the participant and the research assistant across the intervention period.

A within-trial economic evaluation will be conducted whereby clinical outcomes (fatigue-sleep disturbance-depression symptom cluster and quality of life) and cost data will be compared between the true intervention group and the usual care group over 19 weeks. Data on economic-related resource use will be captured using a bespoke questionnaire over 19 weeks from randomization.

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 Survivors	NCT06412107	Breast Neoplasm... Symptom Cluster	True acupressur... 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 sham acupressure