Breast NeoplasmsAIMSS-CARENCT07409948
Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms
A study testing Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms (AIMSS-CARE) in people with Breast Neoplasms and Musculoskeletal Pain, run by Addis Ababa University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Musculoskeletal Pain, Arthralgia
- What is being tested?
- Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms (AIMSS-CARE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Neoplasms, Musculoskeletal Pain, Arthralgia, Musculoskeletal Diseases, Pain, Fatigue Syndrome, Chronic
- Being tested
- Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms (AIMSS-CARE)
- Keywords
- Breast neoplasms, Aromatase inhibitors, endocrine therapy, Randomized controlled trial, pain, quality of life, fatigue, treatment adherence, musculoskeletal symptoms, symptom monitoring, exercise and rehabilitation
- Medical subject headings
- Breast Neoplasms, Musculoskeletal Pain, Arthralgia, Musculoskeletal Diseases, Pain, Fatigue Syndrome, Chronic, Fatigue, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and at 3 and 4 months after enrollment
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and at 3 and 4 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Addis Ababa University
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Principal investigator, Mikiyas Amare Getu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409948
- Sponsor's protocol ID
- HONM/11/18
- Acronym
- AIMSS-CARE
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness and Implementation Outcomes of a Multicomponent Intervention for Aromatase Inhibitor-Associated Musculoskeletal Symptoms: A Hybrid Type 1 Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07409948
- Acronym / sponsor ID
- AIMSS-CARE / HONM/11/18
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Addis Ababa UniversityUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention study | Experimental | Combination Product: Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms (AIMSS-CARE)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Intervention study |
Primary outcome
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.
6 secondary outcomes
Grip Strength
Time frame: At baseline and at 3 and 4 months after enrollment
Medication Adherence
Time frame: At baseline and at 3 and 4 months after enrollment
Overall Health-Related Quality of Life Assessed by EORTC QLQ-C30
Time frame: At baseline and at 3 and 4 months after enrollment
Breast Cancer-Specific Quality of Life assessed by EORTC QLQ-BR45
Time frame: Baseline, 3 months, and 4 months after enrollment.
Exercise Adherence
Time frame: At baseline and at 3 and 4 months after enrollment
implementation outcome
Time frame: At baseline and at 3 and 4 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms (AIMSS-CARE) in people with Breast Neoplasms and Musculoskeletal Pain, run by Addis Ababa University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikiyas Amare Getu, PhD (+251913105648, makmiky86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal Pain Severity and Pain Interference (time frame: At baseline and at 3 and 4 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.