Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS), Breast Neoplasms
Conditions
Keywords
Breast Cancer, Endocrine Therapy, Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS), Evidence-Based Practice, Implementation Science
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).
Interventions
BEHAVIORALCulturally Adapted EBP Program
A comprehensive, culturally tailored symptom management program providing targeted health education, monitoring, and nursing guidance for musculoskeletal symptoms.
Standard clinical follow-up and general nursing care as routinely provided to patients receiving endocrine therapy.
Sponsors
Yuling CAO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Joint Function Assessed by the WOMAC Index | 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. |
| Intervention Implementation Audit Indicator Compliance Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Hand Joint Symptoms Assessed by the M-SACRAH | 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. |
| Change in Bone Mineral Density (BMD) | 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. |
| Change in Grip Strength | 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. |
| Patient Intervention Compliance Rate (Digital Logs and Manual Records) | 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. |
| Practitioners' Knowledge, Attitude, and Practice (KAP) | 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. |
Countries
China
Outcome results
None listed