Clinical trial NCT04118140: Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer
acupressure
fatigue
depression
insomnia
symptom cluster
Lead sponsor: Charles Darwin University
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital Of Southwest Medical University
First posted: 2019-10-08
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: FEASIBILITY: Eligibility rate
timeFrame: Immediately after completion of the intervention (T2)
measure: FEASIBILITY: Recruitment rate
timeFrame: Immediately after completion of the intervention (T2)
measure: FEASIBILITY: Retention rate
timeFrame: Immediately after completion of the intervention (T2)
measure: FEASIBILITY: Attrition rate
timeFrame: Immediately after completion of the intervention (T2)
measure: FEASIBILITY: subject recruitment
timeFrame: Immediately after completion of the intervention (T2)
measure: FEASIBILITY: Duration for completing the subject recruitment
timeFrame: Immediately after completion of the intervention (T2)
measure: ACCEPTABILITY: Actual days of acupressure
timeFrame: Immediately after completion of the intervention (T2)
measure: ACCEPTABILITY: duration of each acupressure session
timeFrame: Immediately after completion of the intervention (T2)
measure: ACCEPTABILITY: SA protocol
timeFrame: Immediately after completion of the intervention (T2)
measure: FEASIBILITY: Questionnaire-Item-level missing value of each questionnaire
timeFrame: Immediately after completion of the intervention (T2)
measure: FEASIBILITY: Questionnaire-Scale-level missing value of the questionnaire
timeFrame: Immediately after completion of the intervention (T2)
measure: SAFETY: adverse events
timeFrame: Immediately once an adverse event occurs
Secondary outcomes:
measure: Fatigue
timeFrame: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
measure: Sleep disturbance
timeFrame: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
measure: Depression
timeFrame: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
measure: Patients' quality of Life
timeFrame: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
Other outcomes:
Locations:
city: Luzhou
country: China
facility: The Affiliated Hospital Of Southwest Medical University
state: Sichuan
Study officials:
affiliation: Charles Darwin University
name: Jing-Yu (Benjamin) Tan, PhD RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang T, Tan JB, Liu XL, Zheng SL, Zhao I, Eliseeva S, Polotan MJ, Cheng HL, Huang HQ. Implementing an evidence-based somatic acupressure intervention in breast cancer survivors with the symptom cluster of fatigue, sleep disturbance and depression: study protocol of a phase II randomised controlled trial. BMJ Open. 2022 Jan 20;12(1):e054597. doi: 10.1136/bmjopen-2021-054597.