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NCT Number: NCT07409948

Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms

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.

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Key information

Conditions

Breast Neoplasms Arthralgia Behavior Breast Diseases Chronic Disease Disease Attributes Encephalomyelitis Fatigue Fatigue Syndrome, Chronic Health Behavior Joint Diseases Motor Activity Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neoplasms Neoplasms by Site Nervous System Diseases Neuroinflammatory Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Capable of understanding the study and willing to sign informed consent.

Exclusion criteria

  • 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.
  • Presence of other primary malignancies.
  • Patients with severe heart, brain, liver, or kidney dysfunction, or infectious diseases.
  • Patients with severe mental, cognitive, or behavioral disorders that hinder understanding or participation in the study.

Treatment and study plan

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

Combination Product

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.

Primary outcomes

  1. Musculoskeletal Pain Severity and Pain Interference

    Time frame: 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 outcomes

  1. Grip Strength

    Time frame: 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.

  2. Medication Adherence

    Time frame: 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.

  3. Overall Health-Related Quality of Life Assessed by EORTC QLQ-C30

    Time frame: 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.

  4. Breast Cancer-Specific Quality of Life assessed by EORTC QLQ-BR45

    Time frame: 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.

  5. Exercise Adherence

    Time frame: 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.

  6. implementation outcome

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mikiyas Amare Getu, PhD

CONTACT

[email protected]

+251913105648

Sponsors and collaborators

Lead sponsor

Addis Ababa University

Other

Collaborators

  • Fudan University

Registry information

Official study title

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

Acronym: AIMSS-CARE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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