Clinical Trial

Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms

Study acronym: AIMSS-CARE
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07409948
Lead Sponsor Addis Ababa University
Collaborators: Fudan University
Conditions Breast Neoplasms, Musculoskeletal Pain, Arthralgia, Musculoskeletal Diseases, Pain, Fatigue Syndrome, Chronic
Enrollment 88 participants
Start Date 2026-03-15
Primary Completion 2026-10 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-02-13