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COVID 19 outbreak and manpower issues
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| Name | Class |
|---|---|
| Huazhong University of Science and Technology Union Shenzhen Hospital | OTHER |
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This study aims to evaluate the feasibility, acceptability and preliminary effects of self-applied acupressure on arthralgia-fatigue-sleep disturbance symptom cluster in breast cancer survivors receiving aromatase inhibitors. This is a preliminary randomized controlled trial, with a three-arm trial design including verum self-acupressure, sham self-acupressure, and usual care. Subjects will include 52 breast cancer survivors who are receiving aromatase inhibitors and have experienced a moderate level of joint pain and at least one of the two symptoms including fatigue and sleep disturbance. Subjects who are randomized to either the verum self-acupressure group (group A) or the sham self-acupressure group (group B) will receive up to 8 weeks of the intervention consisting of two components: (1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks. The method and duration of self-acupressure in the sham group will be the same to those in the verum intervention group. The control group will receive usual care. The outcome measures of this study will be related to feasibility, acceptability and preliminary effects of self-acupressure. Individual in-depth interviews will be conducted with selected participants in group A and B to understand their perceptions and perceived effectiveness of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| True self-acupressure | Experimental | 1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks. |
|
| Sham self-acupressure | Sham Comparator | Same protocol to the true self-acupressure group but on the sham acupoints |
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| Usual care | Other | General advise on managing symptoms provided by healthcare providers |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ture self-acupressure | Other | 8-week intervention of self-acupressure on acupoints |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility measure | Eligibility rate | Immediately after completion of the intervention (T1) |
| Feasibility measure | Recruitment rate | Immediately after completion of the intervention (T1) |
| Feasibility measure | Attrition rate | Immediately after completion of the intervention (T1) |
| Feasibility measure | Time to complete the recruitment | Immediately after completion of the intervention (T1) |
| Feasibility measure | Intervention adherence (using a patient-reported diary to document if the patient has completed the intervention daily, experienced any side effects, any other feelings or thoughts ) | Immediately after completion of the intervention (T1) |
| Acceptability measure | Appropriateness of the intervention components using a self-developed questionnaire (15 close-ended questions mostly on a scale of 1 to 5, higher score indicating higher acceptability and 3 open-ended questions) | Immediately after completion of the intervention (T1) |
| Measure | Description | Time Frame |
|---|---|---|
| Arthralgia | The Brief Pain Inventory- Short Form to assess joint pain related to aromatase inhibitor-induced arthralgia on a scale of 0=no pain, 10=extreme pain | Baseline(T0) and Immediately after completion of the intervention (T1) |
| Fatigue |
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Inclusion Criteria
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Huilin Cheng, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Huazhong University of Science and Technology Union Shenzhen Hospital | Shenzhen | Guangdong | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Sham self-acupressure |
| Other |
8-week intervention of self-acupressure on non-acupoints |
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| Usual care | Other | routine care by hospitals |
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The Brief Fatigue Inventory to measure fatigue on a scale of 0=no fatigue, 10=extreme fatigue
| Baseline(T0) and Immediately after completion of the intervention (T1) |
| Sleep disturbance | The Pittsburgh Sleep Quality Index (PSQI) to measure sleep disturbance (with different item options) [a global score ranges from 0 to 21, with a higher score indicating poor sleep quality] | Baseline(T0) and Immediately after completion of the intervention (T1) |
| Health-related quality of life | The Functional Assessment of Cancer Therapy scale (FACT-G) to measure health-related quality of life on a scale of 0=lower health-related quality of life, 4=higher health-related quality of life | Baseline(T0) and Immediately after completion of the intervention (T1) |
| D017437 |
| Skin and Connective Tissue Diseases |