Clinical Effectiveness and Implementation Outcomes of a Multicomponent Intervention for Aromatase Inhibitor-Associated Musculoskeletal Symptoms: A Hybrid Type 1 Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 主要终点
- Musculoskeletal Pain Severity and Pain Interference
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms (AIMSS-CARE) (Combination Product)
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.
结局指标
主要结局
Musculoskeletal Pain Severity and Pain Interference
时间窗: 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.
次要结局
- 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)
- implementation outcome(At baseline and at 3 and 4 months after enrollment)
研究者
Mikiyas Amare Getu
Dr.
Fudan University