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

Yuling CAO

Status: Completed

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

Treatments: Behavioral: Culturally Adapted EBP Program; Other: Standard Routine Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07500038

2304273-17

Details and patient eligibility

About

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).

Enrollment: 289 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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289 participants in 2 patient groups

Evidence-Based Practice (EBP) Group

Experimental group

Description:

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

Treatment:

Behavioral: Culturally Adapted EBP Program

Routine Care Group

Active Comparator group

Description:

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

Treatment:

Other: Standard Routine Care