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Completed

NCT Number: NCT07500038

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

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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Key information

Conditions

Breast Neoplasms Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS) Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Culturally Adapted EBP Program

Behavioral

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

Standard Routine Care

Other

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

Primary outcomes

  1. Change in Joint Function Assessed by the WOMAC Index

    Time frame: Baseline, 1 month, 3 months, and 6 months post-intervention

    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.

  2. Intervention Implementation Audit Indicator Compliance Rate

    Time frame: Baseline, 1 month, 3 months, and 6 months

    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.

Secondary outcomes

  1. Change in Hand Joint Symptoms Assessed by the M-SACRAH

    Time frame: Baseline, 1 month, 3 months, and 6 months post-intervention

    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.

  2. Change in Bone Mineral Density (BMD)

    Time frame: Baseline and 6 months

    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.

  3. Change in Grip Strength

    Time frame: Baseline, 1 month, 3 months, and 6 months

    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.

  4. Patient Intervention Compliance Rate (Digital Logs and Manual Records)

    Time frame: Baseline, 3 months, and 6 months

    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.

  5. Practitioners' Knowledge, Attitude, and Practice (KAP)

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Yuling CAO

Other

Registry information

Acronym: EBP-MS-BC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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