Evidence-Based Practice for the Management of Musculoskeletal Symptoms in Breast Cancer Patients Undergoing Endocrine Therapy: A Multicultural Perspective (EBP-MS-BC)

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).

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms; Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS)
• Intervention / Treatment: Behavioral: Culturally Adapted EBP Program; Other: Standard Routine Care

• Study Type: Interventional
• Enrollment (Actual): 289
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pathologically diagnosed Hormone Receptor Positive (HR+) primary breast cancer
• Aged 18 years or older
• Currently receiving Aromatase Inhibitors (AIs) endocrine therapy for at least 6 months
• Self-reported Aromatase Inhibitor-induced Musculoskeletal Symptoms (AIMSS)
• Possess basic communication skills, able to understand the research content, and voluntarily provide written informed consent
• For the qualitative implementation evaluation, practitioners must be substantially involved in the clinical implementation of the AIMSS management program (e.g., patient recruitment, intervention delivery, digital tool guidance, or follow-up)
• For the qualitative implementation evaluation, practitioners must provide informed consent for recorded interviews

Exclusion Criteria:

• History of bone fracture or related orthopedic surgery within the past 6 months
• Previously diagnosed with inflammatory joint diseases (e.g., rheumatoid arthritis, ankylosing spondylitis)
• Received other treatments for AIMSS not included in this study protocol within the past 1 month
• Diagnosed with metastatic breast cancer or other primary malignant tumors
• Concurrent serious dysfunction of vital organs (heart, brain, kidney, etc.) or uncontrolled infectious diseases
• Presence of severe mental illness or cognitive impairment that prevents cooperation with the longitudinal study process

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evidence-Based Practice (EBP) Group; Participants receive a culturally adapted evidence-based symptom management program, including targeted health education and nursing guidance.	Behavioral: Culturally Adapted EBP Program; A comprehensive, culturally tailored symptom management program providing targeted health education, monitoring, and nursing guidance for musculoskeletal symptoms.
Active Comparator: Routine Care Group; Participants receive standard routine clinical care without the additional evidence-based management program.	Other: Standard Routine Care; Standard clinical follow-up and general nursing care as routinely provided to patients receiving endocrine therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Yuling CAO

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): January 15, 2026
• Study Completion (Actual): March 10, 2026

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Implementation Science; Endocrine Therapy; Evidence-Based Practice; Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2304273-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No