Clinical trial · Interventional
Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms
Clinical Effectiveness and Implementation Outcomes of a Multicomponent Intervention for Aromatase Inhibitor-Associated Musculoskeletal Symptoms: A Hybrid Type 1 Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthralgia | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Fatigue Syndrome, Chronic | — | UNRESOLVED | — |
| Musculoskeletal Diseases | — | UNRESOLVED | — |
| Musculoskeletal Pain | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms (AIMSS-CARE) | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention study
- description
- Culturally Adapted Multicomponent AIMSS-CARE Participants randomized to the intervention arm will receive a culturally adapted, multicomponent AIMSS-CARE designed to reduce aromatase inhibitor-associated musculoskeletal symptoms and improve quality of life. The intervention includes a structured home-based exercise program (stretching, strengthening, and mobility exercises), nurse-led education on symptom management, medication adherence, and dietary management, and regular symptom self-monitoring. Participants will receive structured follow-up and reinforcement through scheduled contacts with trained oncology nurses and rehabilitation professional. The intervention is delivered in addition to usual oncology care over the study period.
- interventionNames
- Combination Product: Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms (AIMSS-CARE)
- type
- NO_INTERVENTION
- label
- Usual care
- description
- Participants randomized to the usual care arm will receive standard oncology care as routinely provided at Tikur Anbessa Specialized Hospital. Usual care includes routine clinical follow-up, medical and nursing management of breast cancer and treatment-related symptoms, and general advice provided at clinician discretion. No structured exercise program, AIMSS-specific education, symptom self-monitoring tools, or scheduled follow-up related to musculoskeletal symptoms will be provided.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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