Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms

NCT07409948 | Not Yet Recruiting DMC

• 1 other identifier: HONM/11/18
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasms; Musculoskeletal Pain; Arthralgia; Musculoskeletal Diseases; Pain; Fatigue Syndrome, Chronic

Keywords

Breast neoplasms; Aromatase inhibitors; endocrine therapy; Randomized controlled trial; pain; quality of life; fatigue; treatment adherence; musculoskeletal symptoms; symptom monitoring; exercise and rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Grip Strength

  At baseline and at 3 and 4 months after enrollment

• Medication Adherence

  At baseline and at 3 and 4 months after enrollment

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

  At baseline and at 3 and 4 months after enrollment

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

  Baseline, 3 months, and 4 months after enrollment.

• Exercise Adherence

  At baseline and at 3 and 4 months after enrollment

Study Arms (2)

Intervention study

EXPERIMENTAL

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)

Usual care

NO INTERVENTION

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.

Interventions

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.

Intervention study

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Addis Ababa University: lead
• Fudan University: collaborator

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Musculoskeletal Pain; Arthralgia; Musculoskeletal Diseases; Pain; Fatigue Syndrome, Chronic; Fatigue; Treatment Adherence and Compliance; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Muscular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Health Behavior; Behavior

Central Study Contacts

Mikiyas Amare Getu, PhD

CONTACT

+251913105648; makmiky86@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 13, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share