CompletedNot Applicable

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

China289 participantsStarted 2024-12-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Joint Function Assessed by the WOMAC Index

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

Intervention Implementation Audit Indicator Compliance Rate

Timeframe: Baseline, 1 month, 3 months, and 6 months

Trial details

NCT IDNCT07500038

SponsorYuling CAO

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-15

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