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| ID | Type | Description | Link |
|---|---|---|---|
| KET-1375/UN2.F1/ETIK/PPM.00.02 | Registry Identifier | Ethical Approval from Universitas Indonesia |
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This study evaluates whether preoperative shoulder range-of-motion exercises influence postoperative inflammatory response, pain, shoulder function, and quality of life in patients with locally advanced breast cancer undergoing modified radical mastectomy.
Breast cancer patients undergoing modified radical mastectomy are at risk of postoperative pain, shoulder dysfunction, and impaired quality of life, which may be associated with postoperative inflammatory responses. Preoperative rehabilitation strategies, including shoulder range-of-motion exercises, have been proposed to improve postoperative recovery, but evidence in patients with locally advanced breast cancer remains limited.
This study aims to evaluate the effects of a structured preoperative shoulder range-of-motion exercise program on postoperative inflammatory markers, specifically C-reactive protein (CRP), as well as pain intensity, shoulder joint function, and quality of life in patients with locally advanced breast cancer undergoing modified radical mastectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 : Preoperative shoulder exercise | Experimental | Arm 1: Preoperative Shoulder Exercise Participants will receive a structured preoperative shoulder range-of-motion exercise program prior to modified radical mastectomy, in addition to standard preoperative care. |
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| Arm 2 : Standard Preoperative Care | Other | Arm 2: Standard Preoperative Care Participants will receive standard preoperative care without a structured shoulder exercise program prior to modified radical mastectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative shoulder exercise | Behavioral | Arm 1 : Participants in the intervention arm will perform a structured preoperative shoulder range-of-motion exercise program prior to modified radical mastectomy. The exercises are designed to maintain shoulder mobility and are conducted in addition to standard preoperative care. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in C-reactive protein (CRP) level | C-reactive protein (CRP) levels will be measured to assess the postoperative inflammatory response in patients undergoing modified radical mastectomy. | Baseline (preoperative), 1 day before surgery and 1 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form-36 (SF-36) quality-of-life score | The Short Form-36 (SF-36) questionnaire will be used to evaluate health-related quality of life. | Baseline(before intervention), 1-day preoperative and 1 month after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Drop out criteria:
This study includes female patients diagnosed with locally advanced breast cancer undergoing modified radical mastectomy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Freda S Halim, MD, Ph.D | Contact | +62812-99000-530 | freda.susana@ui.ac.id |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia | Jakarta Pusat | Dki Jakarta | 10430 | Indonesia |
Individual participant data will not be shared because no formal data-sharing plan was included in the ethics-approved study protocol.
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| Standard preoperative care | Other | Participants will receive standard preoperative care without a structured shoulder exercise program prior to modified radical mastectomy. |
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