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The purpose of this implementation study is to evaluate the application of an evidence-based practice (EBP) program for managing musculoskeletal symptoms in breast cancer patients receiving endocrine therapy, from a multicultural perspective.
The main questions it aims to answer are:
Is the culturally adapted EBP program feasible and acceptable to implement in real-world clinical settings? Does the implementation of this program effectively reduce patients' musculoskeletal symptoms and improve their quality of life? Researchers will compare the group receiving the cross-culturally adapted evidence-based management with a group receiving standard routine care.
During the study:
Healthcare providers will implement the culturally tailored symptom management program.
Participants will receive targeted health education and nursing guidance based on their cultural context.
Researchers will collect data on how well the program is adopted (implementation outcomes), as well as evaluate changes in patients' joint symptoms and overall well-being at designated follow-up times (clinical outcomes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evidence-Based Practice (EBP) Group | Experimental | Participants receive a culturally adapted evidence-based symptom management program, including targeted health education and nursing guidance. |
|
| Routine Care Group | Active Comparator | Participants receive standard routine clinical care without the additional evidence-based management program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally Adapted EBP Program | Behavioral | A comprehensive, culturally tailored symptom management program providing targeted health education, monitoring, and nursing guidance for musculoskeletal symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Joint Function Assessed by the WOMAC Index | Joint function is assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Each of the 24 items is evaluated using a 100mm Visual Analog Scale (VAS), with the total raw score ranging from 0 to 2400. Higher scores indicate worse joint function and more severe symptoms. | Baseline, 1 month, 3 months, and 6 months post-intervention |
| Intervention Implementation Audit Indicator Compliance Rate | The compliance rate is calculated as the number of successfully implemented evidence-based criteria divided by the total number of audited criteria, expressed as a percentage (0-100%). Higher percentages indicate better adherence to the intervention protocol. | Baseline, 1 month, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hand Joint Symptoms Assessed by the M-SACRAH | Hand joint symptoms are assessed using the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH). Each of the 12 items is evaluated using a Visual Analog Scale (VAS), with the total raw score ranging from 0 to 1200. Higher scores indicate more severe hand joint symptoms and worse hand function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
Individual participant data (IPD) will not be shared to protect the privacy and confidentiality of the participants, as the dataset contains sensitive clinical and personal information. Additionally, current institutional policies and agreements across the multiple study sites do not support the public sharing of individual-level data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2023 | Mar 22, 2026 |
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| Standard Routine Care | Other | Standard clinical follow-up and general nursing care as routinely provided to patients receiving endocrine therapy. |
|
| Baseline, 1 month, 3 months, and 6 months post-intervention |
| Change in Bone Mineral Density (BMD) | Bone mineral density (BMD) is measured using dual-energy X-ray absorptiometry (DXA). The outcome is reported as T-scores. Lower T-scores indicate lower bone mineral density. | Baseline and 6 months |
| Change in Grip Strength | Grip strength is measured using a hand dynamometer. The outcome is reported in kilograms (kg). Higher values indicate stronger hand grip strength and better muscle function. | Baseline, 1 month, 3 months, and 6 months |
| Patient Intervention Compliance Rate (Digital Logs and Manual Records) | Patient compliance with the intervention is assessed using a hybrid tracking approach. Primary compliance data is extracted from the study's dedicated mobile application logs. For participants unable to use the app or during periods of technical interruption, compliance is tracked via manual nurse follow-up records and alternative communication platforms. Overall compliance is calculated as the number of completed intervention sessions divided by the total number of prescribed sessions, expressed as a percentage. The value ranges from 0 to 100%. Higher percentages indicate better adherence to the intervention protocol. | Baseline, 3 months, and 6 months |
| Practitioners' Knowledge, Attitude, and Practice (KAP) | Practitioners' Knowledge, Attitude, and Practice (KAP) are assessed using an investigator-developed questionnaire. The total score is standardized to a range from 0 to 100. Higher scores indicate a higher level of knowledge, more positive attitudes, and better evidence-based clinical practice behaviors. | Baseline |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 17, 2023 | Mar 22, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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