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Postmenopausal women with hormone receptor-positive breast cancer are now prescribed aromatase inhibitors with 5 years or longer durations of therapy as recommended by clinical guidelines, which contributes to reducing breast cancer recurrence. However, aromatase inhibitors treatment is associated with a high incidence of musculoskeletal symptoms (MSS), often described as symmetrical pain, soreness in the joints, musculoskeletal pain, and joint stiffness, which even leads to bone loss, osteoporosis, and fractures. MSS reduces patients' quality of life and compliance with aromatase inhibitors therapy in up to one-half of women undergoing adjuvant aromatase inhibitors therapy, potentially compromising breast cancer outcomes. Therefore, this study aimed to monitor the musculoskeletal health of breast cancer patients during endocrine therapy to provide references for clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Routine care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in hand function | Measured with score for assessment and quantification of chronic rheumatic affections of the hands (SACRAH). | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. |
| Changes in wrist function | Measured with Boston Carpal Tunnel Questionnaire (BCTQ). | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. |
| Changes in knee or hip joint function | Measured with Western Ontario and McMaster Osteoarthritis Index (WOMAC). | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Grip strength | Measured with CAMRY EH101 electronic grip strength meter (Made in China). | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. |
| Bone mineral density | Measured with Lunar iDXA (Made in China). |
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Inclusion Criteria:
Exclusion Criteria:
Participant eligibility is based on self-representation of gender identity.
Postoperative patients with hormone receptor-positive breast cancer and treated with aromatase inhibitors in Shanghai Cancer Center, Fudan University, Shanghai, China.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Nursing, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
There is no plan to make individual participant data available to other researchers.
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Peripheral blood
| Baseline, 12 months, and 24 months. |
| Depression and Anxiety | Measured with the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. |
| Medication adherence | Measured with self-reported medication adherence visual analogue scale (VAS). | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. |