- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04118140
Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients
July 19, 2022 updated by: Charles Darwin University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Luzhou, Sichuan, China, 646000
- The Affiliated Hospital of Southwest Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- BC stage I to IIIa;
- 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;
- have completed adjuvant chemotherapy for at least one month and up to three years;
- have not scheduled chemotherapy and radiotherapy during the whole study period;
- willing to participate in the RCT and provide written informed consent.
Exclusion criteria:
- presently taking pharmaceutical agents to treat fatigue, sleep disturbance or depression, such as antidepressant medications, psychostimulants, or hypnotics;
- extremely weak and/or have cognitive impairment which make them unable (or difficult) to follow the study procedures and instructions;
- having the experience of any types of SAS treatment during the past six months;
- presently participating in any other research projects.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: True SA (Somatic Acupressure ) group
Receiving true somatic acupressure+usual care
|
7-week self-acupressure plus usual care (an education booklet)
Usual care only (an education booklet)
|
Sham Comparator: Sham SA group
Receiving sham somatic acupressure+usual care
|
Usual care only (an education booklet)
Same dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet)
|
Other: Usual care group
Receiving usual care only (an education booklet regarding knowledge of BC and FSD symptom cluster management advice)
|
Usual care only (an education booklet)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FEASIBILITY: Eligibility rate
Time Frame: Immediately after completion of the intervention (T2)
|
Eligibility rate as assessed by (the number of eligible participants / number of participants screened) x 100%
|
Immediately after completion of the intervention (T2)
|
FEASIBILITY: Recruitment rate
Time Frame: Immediately after completion of the intervention (T2)
|
Recruitment rate as assessed by (the number of participants who participated in the study / number of eligible participants) x 100%
|
Immediately after completion of the intervention (T2)
|
FEASIBILITY: Retention rate
Time Frame: Immediately after completion of the intervention (T2)
|
Retention rate as assessed by (the number of participants who completed the study / number of participants who enrolled in) x 100%
|
Immediately after completion of the intervention (T2)
|
FEASIBILITY: Attrition rate
Time Frame: Immediately after completion of the intervention (T2)
|
Attrition rate as assessed by (the number of participants who dropped out after the randomization / number of participants who enrolled in) x 100%
|
Immediately after completion of the intervention (T2)
|
FEASIBILITY: subject recruitment
Time Frame: Immediately after completion of the intervention (T2)
|
Feasibility of subject recruitment assessed by interviewing the participants' feedback regarding why they discontinued this study
|
Immediately after completion of the intervention (T2)
|
FEASIBILITY: Duration for completing the subject recruitment
Time Frame: Immediately after completion of the intervention (T2)
|
Time period from the recruitment of first participants to the last patient: assessed by months
|
Immediately after completion of the intervention (T2)
|
ACCEPTABILITY: Actual days of acupressure
Time Frame: Immediately after completion of the intervention (T2)
|
The number of days that the participants perform the SA interventions, where the scheduled sessions should be 7 weeks of daily acupressure
|
Immediately after completion of the intervention (T2)
|
ACCEPTABILITY: duration of each acupressure session
Time Frame: Immediately after completion of the intervention (T2)
|
Duration of each time (minutes) of acupressure where the scheduled time per session should be around 36 minutes
|
Immediately after completion of the intervention (T2)
|
ACCEPTABILITY: SA protocol
Time Frame: Immediately after completion of the intervention (T2)
|
Participants' feedback and satisfaction with the SA intervention assessed by a self-designed feedback form and follow-up semi-structured interviews
|
Immediately after completion of the intervention (T2)
|
FEASIBILITY: Questionnaire-Item-level missing value of each questionnaire
Time Frame: Immediately after completion of the intervention (T2)
|
Item-level missing value of each questionnaire (%) assessed by the percentage of participants who do not answer any single item
|
Immediately after completion of the intervention (T2)
|
FEASIBILITY: Questionnaire-Scale-level missing value of the questionnaire
Time Frame: Immediately after completion of the intervention (T2)
|
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
|
Immediately after completion of the intervention (T2)
|
SAFETY: adverse events
Time Frame: Immediately once an adverse event occurs
|
Number of adverse events occur during the intervention
|
Immediately once an adverse event occurs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue
Time Frame: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
|
Fatigue measured by the Multidimensional Fatigue Inventory
|
Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
|
Sleep disturbance
Time Frame: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
|
Insomnia measured by Pittsburgh Sleep Quality Index
|
Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
|
Depression
Time Frame: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
|
Depression measured by Hospital Anxiety and Depression Scale
|
Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
|
Patients' quality of Life
Time Frame: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
|
Measured by the Functional Assessment of Cancer Therapy-Breast Cancer
|
Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jing-Yu (Benjamin) Tan, PhD RN, Charles Darwin University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2021
Primary Completion (Actual)
May 17, 2022
Study Completion (Actual)
July 20, 2022
Study Registration Dates
First Submitted
September 27, 2019
First Submitted That Met QC Criteria
October 3, 2019
First Posted (Actual)
October 8, 2019
Study Record Updates
Last Update Posted (Actual)
July 21, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H19017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on Somatic Acupressure
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityNot yet recruitingAge-Related Macular Degeneration
-
University Hospital, AntwerpCompleted
-
CHU de ReimsUnknown
-
Chang-Hua HospitalChina Medical University HospitalUnknownInsomnia | Anxiety | Menopause | Auricular AcupressureTaiwan
-
Montana State UniversityCompletedOccupational-based Secondary TraumaUnited States
-
Mersin UniversityRecruiting
-
Mersin UniversityCompleted
-
Cairo UniversityCompleted
-
China Medical University HospitalNot yet recruiting
-
Guangdong Provincial Hospital of Traditional Chinese...Completed