Breast NeoplasmsEBP-MS-BCNCT07500038
Evidence-Based Practice for the Management of Musculoskeletal Symptoms in Breast Cancer Patients Undergoing Endocrine Therapy: A Multicultural Perspective
A study testing Culturally Adapted EBP Program and Standard Routine Care in people with Breast Neoplasms and Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS), run by Yuling CAO at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS)
- What is being tested?
- Culturally Adapted EBP Program and Standard Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
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:
Read more
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).
- Being tested
- Culturally Adapted EBP Program, Standard Routine Care
- Keywords
- Breast Cancer, Endocrine Therapy, Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS), Evidence-Based Practice, Implementation Science
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Adapted EBP ProgramBehavioural
A comprehensive, culturally tailored symptom management program providing targeted health education, monitoring, and nursing guidance for musculoskeletal symptoms.
Standard Routine CareOther
Standard clinical follow-up and general nursing care as routinely provided to patients receiving endocrine therapy.
| Study group | Role | What they receive |
|---|---|---|
| Evidence-Based Practice (EBP) Group | Experimental | Participants receive a culturally adapted evidence-based symptom management program, including targeted health education and nursing guidance. Receives: Behavioral: Culturally Adapted EBP Program |
| Routine Care Group | Active comparator | Participants receive standard routine clinical care without the additional evidence-based management program. Receives: Other: Standard Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 1 month, 3 months, and 6 months
Secondary outcomes (5)
Change in Hand Joint Symptoms Assessed by the M-SACRAH
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.
Measured: Baseline, 1 month, 3 months, and 6 months post-intervention
Change in Bone Mineral Density (BMD)
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.
Measured: Baseline and 6 months
Change in Grip Strength
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.
Measured: Baseline, 1 month, 3 months, and 6 months
Patient Intervention Compliance Rate (Digital Logs and Manual Records)
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.
Measured: Baseline, 3 months, and 6 months
Practitioners' Knowledge, Attitude, and Practice (KAP)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Dec 2024
- Primary completion15 Jan 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuling CAO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuling CAO, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500038
- Sponsor's protocol ID
- 2304273-17
- Acronym
- EBP-MS-BC
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect the privacy and confidentiality of the participants, as the dataset contains sensitive clinical and personal information. Additionally, current institutional policies and agreements across the multiple study sites do not support the public sharing of individual-level data.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-Based Practice for the Management of Musculoskeletal Symptoms in Breast Cancer Patients Undergoing Endocrine Therapy: A Multicultural Perspective
- ClinicalTrials.gov ID
- NCT07500038
- Acronym / sponsor ID
- EBP-MS-BC / 2304273-17
- Keywords
- Breast Cancer, Endocrine Therapy, Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS), Evidence-Based Practice, Implementation Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Yuling CAOUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evidence-Based Practice (EBP) Group | Experimental | Behavioral: Culturally Adapted EBP ProgramParticipants receive a culturally adapted evidence-based symptom management program, including targeted health education and nursing guidance. |
| Routine Care Group | Active comparator | Other: Standard Routine CareParticipants receive standard routine clinical care without the additional evidence-based management program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Adapted EBP ProgramA comprehensive, culturally tailored symptom management program providing targeted health education, monitoring, and nursing guidance for musculoskeletal symptoms. | Behavioural | Evidence-Based Practice (EBP) Group |
| Standard Routine CareStandard clinical follow-up and general nursing care as routinely provided to patients receiving endocrine therapy. | Other | Routine Care Group |
Primary outcome
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.
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.
5 secondary outcomes
Change in Hand Joint Symptoms Assessed by the M-SACRAH
Time frame: Baseline, 1 month, 3 months, and 6 months post-intervention
Change in Bone Mineral Density (BMD)
Time frame: Baseline and 6 months
Change in Grip Strength
Time frame: Baseline, 1 month, 3 months, and 6 months
Patient Intervention Compliance Rate (Digital Logs and Manual Records)
Time frame: Baseline, 3 months, and 6 months
Practitioners' Knowledge, Attitude, and Practice (KAP)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect the privacy and confidentiality of the participants, as the dataset contains sensitive clinical and personal information. Additionally, current institutional policies and agreements across the multiple study sites do not support the public sharing of individual-level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Adapted EBP Program and Standard Routine Care in people with Breast Neoplasms and Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS), run by Yuling CAO at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Joint Function Assessed by the WOMAC Index (time frame: Baseline, 1 month, 3 months, and 6 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.