Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms (AIMSS-CARE)

Clinical Effectiveness and Implementation Outcomes of a Multicomponent Intervention for Aromatase Inhibitor-Associated Musculoskeletal Symptoms: A Hybrid Type 1 Randomized Controlled Trial

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 Overview

• Status: Not yet recruiting
• Conditions: Pain; Breast Neoplasms; Musculoskeletal Diseases; Arthralgia; Musculoskeletal Pain; Fatigue Syndrome, Chronic
• Intervention / Treatment: Combination product: Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms (AIMSS-CARE)

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.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mikiyas Amare Getu, PhD; Phone Number: +251913105648; Email: makmiky86@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention study; 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.	Combination product: Multicomponent 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.
No Intervention: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and at 3 and 4 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and at 3 and 4 months after enrollment
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.	At baseline and at 3 and 4 months after enrollment
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.	At baseline and at 3 and 4 months after enrollment
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.	Baseline, 3 months, and 4 months after enrollment.
Exercise Adherence	Exercise adherence will be measured as the percentage of prescribed exercise sessions completed per week, based on participant exercise logs.	At baseline and at 3 and 4 months after enrollment
implementation outcome	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.	At baseline and at 3 and 4 months after enrollment

Collaborators and Investigators

• Sponsor: Addis Ababa University
• Collaborators: Fudan University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 7, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: pain; fatigue; quality of life; Randomized controlled trial; Aromatase inhibitors; treatment adherence; Breast neoplasms; endocrine therapy; musculoskeletal symptoms; symptom monitoring; exercise and rehabilitation
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Neurologic Manifestations; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Encephalomyelitis; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Joint Diseases; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Skin and Connective Tissue Diseases; Signs and Symptoms; Health Behavior; Pain; Fatigue Syndrome, Chronic; Musculoskeletal Pain; Breast Neoplasms; Fatigue; Arthralgia; Musculoskeletal Diseases; Motor Activity; Treatment Adherence and Compliance
• Other Study ID Numbers: HONM/11/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No