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| Name | Class |
|---|---|
| The Affiliated Hospital Of Southwest Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| True SA (Somatic Acupressure ) group | Experimental | Receiving true somatic acupressure+usual care |
|
| Sham SA group | Sham Comparator | Receiving sham somatic acupressure+usual care |
|
| Usual care group | Other | Receiving usual care only (an education booklet regarding knowledge of BC and FSD symptom cluster management advice) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatic Acupressure | Other | 7-week self-acupressure plus usual care (an education booklet) |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEASIBILITY: Eligibility rate | 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 | 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 | 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 | 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 | 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | 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 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing-Yu (Benjamin) Tan, PhD RN | Charles Darwin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital Of Southwest Medical University | Luzhou | Sichuan | 646000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35058263 | Derived | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005221 | Fatigue |
| D003863 | Depression |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D013577 | Syndrome |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.
| Sham acupressure | Other | Same dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet) |
|
| Usual care | Other | Usual care only (an education booklet) |
|
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 | 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 | 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 | 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 | 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 | Number of adverse events occur during the intervention | Immediately once an adverse event occurs |
Insomnia measured by Pittsburgh Sleep Quality Index
| 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 | 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 | Data collection will be conducted at baseline (T1) and immediately after completion of the intervention (T2) |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D004194 | Disease |
| D010335 | Pathologic Processes |