Arthralgia, Breast Neoplasms, Fatigue Syndrome, Chronic, Musculoskeletal Diseases, Musculoskeletal Pain, Pain
Conditions
Keywords
Breast neoplasms, Aromatase inhibitors, endocrine therapy, Randomized controlled trial, pain, quality of life, fatigue, treatment adherence, musculoskeletal symptoms, symptom monitoring, exercise and rehabilitation
Brief 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.
Detailed description
Aromatase-inhibitor-induced musculoskeletal symptoms (AIMSS) are among the most common adverse effects of endocrine therapy for hormone receptor-positive breast cancer and represent a major cause of reduced physical function, poor quality of life, and early discontinuation of therapy. While a multicomponent AIMSS-CARE intervention developed in China has demonstrated significant clinical benefits, no effectiveness or implementation studies have been conducted in settings. This study aims to culturally adapt and evaluate the effectiveness and implementation of a multicomponent AIMSS intervention among Ethiopian breast cancer patients receiving aromatase inhibitors at Tikur Anbessa Specialized Hospital (TASH). The study uses a Hybrid Type-1 randomized controlled trial design, simultaneously testing clinical effectiveness while collecting data on implementation processes. A total of 88 eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or a usual-care control group. The intervention includes home-based exercise training, symptom self-monitoring, nurse-led education on AIMSS management and medication adherence, dietary guidance, and structured follow-up. The intervention will be culturally adapted through stakeholder engagement, language translation, and contextual tailoring. The primary clinical outcome is musculoskeletal pain measured using the Amharic version of the Brief Pain Inventory. Secondary outcomes include grip strength, health-related quality of life, functional mobility, exercise adherence, medication adherence, and clinician compliance with intervention protocols. Implementation outcomes will be evaluated using the PARiHS (Promoting Action on Research Implementation in Health Services) framework which provides a way to implement research into practice, including three factors that determine the research use: Evidence(E), Context(C), and Facilitation(F). Data will be collected through qualitative interviews with patients and healthcare providers, intervention delivery audits, and adherence tracking tools. This study will provide the first evidence on AIMSS intervention effectiveness and implementation in Ethiopia, strengthen oncology nursing practice, and generate a scalable, culturally adaptable model for improving endocrine therapy adherence across African cancer centers.
Interventions
COMBINATION_PRODUCTMulticomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms (AIMSS-CARE)
AIMSS-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.
Sponsors
Addis Ababa University
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Musculoskeletal Pain Severity and Pain Interference | At baseline and at 3 and 4 months after enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip Strength | At baseline and at 3 and 4 months after enrollment | 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 | At baseline and at 3 and 4 months after enrollment | 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 | At baseline and at 3 and 4 months after enrollment | 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 | Baseline, 3 months, and 4 months after enrollment. | 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. |
| Exercise Adherence | At baseline and at 3 and 4 months after enrollment | Exercise adherence will be measured as the percentage of prescribed exercise sessions completed per week, based on participant exercise logs. |
| implementation outcome | At baseline and at 3 and 4 months after enrollment | The implementation outcome will be determined through three implementation outcomes assessment which involves evaluating three specific indicators of the intervention's acceptability and implementation feasibility and its fidelity. The research team will implement the assessment process using brief structured questionnaires which participants and healthcare providers will complete to evaluate three different implementation outcomes. Higher implementation outcomes will result from participants and healthcare providers achieving better assessment scores. |
Contacts
CONTACTMikiyas Amare Getu, PhD
Outcome results
None listed