CancerNCT04118140
Somatic Acupressure for Symptom Cluster Management in Breast Cancer Patients
A study testing Somatic Acupressure in people with Cancer, run by Charles Darwin University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Somatic Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2021to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital Of Southwest Medical University
Luzhou, Sichuan, 646000
About this study
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
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.
Read the 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
- Being tested
- Somatic Acupressure, Sham acupressure, Usual care
- Keywords
- Cancer, acupressure, fatigue, depression, insomnia, symptom cluster
- Medical subject headings
- Neoplasms, Fatigue, Depression, Sleep Initiation and Maintenance Disorders, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatic AcupressureOther
7-week self-acupressure plus usual care (an education booklet)
Sham acupressureOther
Same dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet)
Usual careOther
Usual care only (an education booklet)
| Study group | Role | What they receive |
|---|---|---|
| True SA (Somatic Acupressure ) group | Experimental | Receiving true somatic acupressure+usual care Receives: Other: Somatic Acupressure; Other: Usual care |
| Sham SA group | Sham comparator | Receiving sham somatic acupressure+usual care Receives: Other: Sham acupressure; Other: Usual care |
| Usual care group | Other | Receiving usual care only (an education booklet regarding knowledge of BC and FSD symptom cluster management advice) Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEASIBILITY: Eligibility rate
Eligibility rate as assessed by (the number of eligible participants / number of participants screened) x 100%
Measured: Immediately after completion of the intervention (T2)
FEASIBILITY: Recruitment rate
Recruitment rate as assessed by (the number of participants who participated in the study / number of eligible participants) x 100%
Measured: Immediately after completion of the intervention (T2)
FEASIBILITY: Retention rate
Retention rate as assessed by (the number of participants who completed the study / number of participants who enrolled in) x 100%
Measured: Immediately after completion of the intervention (T2)
FEASIBILITY: Attrition rate
Attrition rate as assessed by (the number of participants who dropped out after the randomization / number of participants who enrolled in) x 100%
Measured: Immediately after completion of the intervention (T2)
FEASIBILITY: subject recruitment
Feasibility of subject recruitment assessed by interviewing the participants' feedback regarding why they discontinued this study
Measured: Immediately after completion of the intervention (T2)
FEASIBILITY: Duration for completing the subject recruitment
Time period from the recruitment of first participants to the last patient: assessed by months
Measured: Immediately after completion of the intervention (T2)
ACCEPTABILITY: Actual days of acupressure
The number of days that the participants perform the SA interventions, where the scheduled sessions should be 7 weeks of daily acupressure
Measured: Immediately after completion of the intervention (T2)
ACCEPTABILITY: duration of each acupressure session
Duration of each time (minutes) of acupressure where the scheduled time per session should be around 36 minutes
Measured: Immediately after completion of the intervention (T2)
ACCEPTABILITY: SA protocol
Participants' feedback and satisfaction with the SA intervention assessed by a self-designed feedback form and follow-up semi-structured interviews
Measured: Immediately after completion of the intervention (T2)
FEASIBILITY: Questionnaire-Item-level missing value of each questionnaire
Item-level missing value of each questionnaire (%) assessed by the percentage of participants who do not answer any single item
Measured: Immediately after completion of the intervention (T2)
FEASIBILITY: Questionnaire-Scale-level missing value of the questionnaire
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
Measured: Immediately after completion of the intervention (T2)
SAFETY: adverse events
Number of adverse events occur during the intervention
Measured: Immediately once an adverse event occurs
Secondary outcomes (4)
Fatigue
Fatigue measured by the Multidimensional Fatigue Inventory
Measured: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
Sleep disturbance
Insomnia measured by Pittsburgh Sleep Quality Index
Measured: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
Depression
Depression measured by Hospital Anxiety and Depression Scale
Measured: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
Patients' quality of Life
Measured by the Functional Assessment of Cancer Therapy-Breast Cancer
Measured: Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start15 Mar 2021
- Primary completion17 May 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Darwin University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital Of Southwest Medical University
- Responsible party
- Sponsor
- Investigators
- Jing-Yu (Benjamin) Tan, PhD RN, Principal investigator, Charles Darwin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118140
- Sponsor's protocol ID
- H19017
- Status last verified
- Jul 2022
- First submitted
- 27 Sep 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35058263
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04118140
- Acronym / sponsor ID
- H19017
- Conditions
- Cancer
- Keywords
- Cancer, acupressure, fatigue, depression, insomnia, symptom cluster
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Charles Darwin UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital Of Southwest Medical University
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| True SA (Somatic Acupressure ) group | Experimental | Other: Somatic Acupressure, Other: Usual careReceiving true somatic acupressure+usual care |
| Sham SA group | Sham comparator | Other: Sham acupressure, Other: Usual careReceiving sham somatic acupressure+usual care |
| Usual care group | Other | Other: Usual careReceiving usual care only (an education booklet regarding knowledge of BC and FSD symptom cluster management advice) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatic Acupressure7-week self-acupressure plus usual care (an education booklet) | Other | True SA (Somatic Acupressure ) group |
| Sham acupressureSame dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet) | Other | Sham SA group |
| Usual careUsual care only (an education booklet) | Other | Sham SA group, True SA (Somatic Acupressure ) group, Usual care group |
Primary outcome
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%
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%
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%
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%
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
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
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
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
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
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
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
SAFETY: adverse events
Time frame: Immediately once an adverse event occurs
Number of adverse events occur during the intervention
4 secondary outcomes
Fatigue
Time frame: 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)
Depression
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 35058263Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing-Yu (Benjamin) Tan, PhD RN principal investigator
Charles Darwin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatic Acupressure in people with Cancer, run by Charles Darwin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEASIBILITY: Eligibility rate (time frame: Immediately after completion of the intervention (T2)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.