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.
Pathologically confirmed hormone receptor-positive (HR+) breast cancer.
Aged 18 years or older.
Currently receiving aromatase inhibitor therapy (e.g., anastrozole, letrozole, or exemestane) for at least 2 months.
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.
History of fracture or major surgery within the past 6 months.
Patients diagnosed with arthritis (e.g., rheumatoid arthritis).
Patients diagnosed with osteoporosis according to WHO criteria (T-score -2.5).
Recurrent or metastatic breast cancer, or receipt of chemotherapy or radiotherapy during the study period.
Parallel
Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms (AIMSS-CARE)
Combination productAIMSS-CARE uses multiple elements to help breast cancer patients who experience musculoskeletal symptom from their aromatase inhibitor treatment during Aromatase inhibitor endocrine therapy. The program originated from a China-based evidence-based intervention which underwent adaptation through language translation and cultural adaptation to become suitable for use in Ethiopia. The intervention includes four components which function as a unified system through its home-based exercise program which includes joint mobility exercises and muscle strengthening exercises and stretching exercises and functional movement exercises and nurse led education program which educates patients about aromatase inhibitor musculoskeletal symptoms and self-management, medication adherence, diet and exercise and self-monitoring system.
Musculoskeletal Pain Severity and Pain Interference
The research will evaluate musculoskeletal pain through the application of the Amharic version of the Brief Pain Inventory (BPI-Am), which functions as a validated pain assessment tool in Ethiopia. The BPI-Am assessment evaluates pain intensity through worst pain, least pain, average pain, and current pain measurements while assessing pain interference through its impact on daily activities that include general activities, emotional states, walking capability, work performance, social interactions, sleep patterns, and overall life enjoyment. Participants will self-report pain using numeric rating scales ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The scoring system shows that higher scores lead to both increased pain intensity and increased pain impact on daily activities. The primary analysis will compare changes in BPI-Am pain severity and interference scores between the intervention and usual care groups over the study period.
Grip Strength
Grip strength will be measured using a handheld dynamometer following standardized procedures. Measurements will be taken for the dominant hand, and higher values indicate greater muscle strength.
Medication Adherence
Medication adherence to aromatase inhibitor therapy will be assessed as the percentage of prescribed doses taken per week, based on participant self-report and/or adherence logs.
Overall Health-Related Quality of Life Assessed by EORTC QLQ-C30
Quality of life(QoL) will be assessed through validated Amharic versions of European Organization for Research and Treatment of Cancer EORTC questionnaires. Overall health-related quality of life will be measured using the validated Amharic version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The instrument assesses global health status, functional domains, and symptom severity in patients with cancer. Higher functional and global health scale scores represent improved quality of life, while higher symptom scores show increased symptom burden.
Breast Cancer-Specific Quality of Life assessed by EORTC QLQ-BR45
Breast cancer-specific quality of life will be assessed using the validated Amharic version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module (EORTC QLQ-BR45). This instrument evaluates breast cancer-related functioning, symptoms, and treatment-related concerns. Higher scores on functional scales indicate better quality of life, while higher scores on symptom scales indicate greater symptom burden.
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