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

NCT07500038 | Completed

• 1 other identifier: 2304273-17
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Breast Neoplasms; Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS)

Keywords

Breast Cancer; Endocrine Therapy; Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS); Evidence-Based Practice; Implementation Science

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in Hand Joint Symptoms Assessed by the M-SACRAH

  Baseline, 1 month, 3 months, and 6 months post-intervention

• Change in Bone Mineral Density (BMD)

  Baseline and 6 months

• Change in Grip Strength

  Baseline, 1 month, 3 months, and 6 months

• Patient Intervention Compliance Rate (Digital Logs and Manual Records)

  Baseline, 3 months, and 6 months

• Practitioners' Knowledge, Attitude, and Practice (KAP)

  Baseline

Study Arms (2)

Evidence-Based Practice (EBP) Group

EXPERIMENTAL

Participants receive a culturally adapted evidence-based symptom management program, including targeted health education and nursing guidance.

Behavioral: Culturally Adapted EBP Program

Routine Care Group

ACTIVE COMPARATOR

Participants receive standard routine clinical care without the additional evidence-based management program.

Other: Standard Routine Care

Interventions

Culturally Adapted EBP Program BEHAVIORAL

A comprehensive, culturally tailored symptom management program providing targeted health education, monitoring, and nursing guidance for musculoskeletal symptoms.

Evidence-Based Practice (EBP) Group

Standard Routine Care OTHER

Standard clinical follow-up and general nursing care as routinely provided to patients receiving endocrine therapy.

Routine Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuling CAO: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master's Student

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 30, 2026
• Study Start: December 1, 2024
• Primary Completion: January 15, 2026
• Study Completion: March 10, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)