Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms
Not yet recruitingNot applicableNCT07409948
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Breast cancer patients who receive endocrine therapy particularly aromatase inhibitors often experience aromatase inhibitors associated symptoms (AIMSS) such as joint and muscle pain along with stiffness and fatigue that can disrupt with daily activities and lead some patients to stop treatment early. A structured intervention program named AIMSS-CARE (Aromatase Inhibitor-associated Musculoskeletal Symptoms-Comprehensive Adapted Rehabilitation Evaluation) developed in China that combines exercise, education, symptom monitoring, and follow-up has been shown to reduce these symptoms and improve treatment adherence. This study will adapt this program for use in Ethiopia while testing its effectiveness to enhance pain management, treatment adherence and quality of life among Ethiopian breast cancer patients receiving endocrine therapy. The study will be conducted at Tikur Anbessa Specialized Hospital in Addis Ababa, Ethiopia. Eighty-eight patients will be randomly assigned to either the adapted intervention program or usual care. The research will also examine the feasibility and acceptability of the intervention to patients and healthcare providers, and what factors influence its successful implementation. Results will help determine whether this program can be used more widely in Ethiopia and other African cancer centers.
Study details
- Official title
- Clinical Effectiveness and Implementation Outcomes of a Multicomponent Intervention for Aromatase Inhibitor-Associated Musculoskeletal Symptoms: A Hybrid Type 1 Randomized Controlled Trial
- Conditions
- Breast Neoplasms
- Musculoskeletal Pain
- Arthralgia
- Musculoskeletal Diseases
- Pain
- Fatigue Syndrome, Chronic
- Interventions
- Combination product: Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms (AIMSS-CARE)
- Sponsor
- Addis Ababa University
- Collaborators
- Fudan University
- Start date
- 2026-03-15
- Primary completion
- 2026-10
- Sex
- Female
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Pathologically confirmed hormone receptor-positive (HR+) breast cancer. 2. Aged 18 years or older. 3. Currently receiving aromatase inhibitor therapy (e.g., anastrozole, letrozole, or exemestane) for at least 2 months. 4. Experiencing aromatase inhibitor-induced musculoskeletal symptoms, defined as a worst joint pain score ≥ 2/10 on the Brief Pain Inventory (BPI) during the past 7 days. 5. Capable of understanding the study and willing to sign informed consent. Exclusion Criteria: 1. History of fracture or major surgery within the past 6 months. 2. Patients diagnosed with arthritis (e.g., rheumatoid arthritis). 3. Patients diagnosed with osteoporosis according to WHO criteria (T-score -2.5). 4. Recurrent or metastatic breast cancer, or receipt of chemotherapy or radiotherapy during the study period. 5. Presence of other primary malignancies. 6. Patients with severe heart, brain, liver, or kidney dysfunction, or infectious diseases. 7. Patients with severe mental, cognitive, or behavioral disorders that hinder understanding or participation in the study.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07409948