Randomized Clinical Trial Evaluating the Efficacy and Implementation of an Early Adapted Physical Activity to Prevent and Manage Aromatase Inhibitor-induced Musculoskeletal Pain in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 182
- 试验地点
- 4
- 主要终点
- Score of most intense musculoskeletal pain
研究概览
简要总结
Aromatase inhibitors (AI) are the standard adjuvant hormone therapy for postmenopausal women with hormone-sensitive breast cancer. However, nearly half of patients experience AI-induced musculoskeletal symptoms (AIMSS), particularly pain, which compromise quality of life and treatment adherence. While adapted physical activity offers proven benefits in oncology, its specific role in preventing or managing AIMSS remains unclear. Moreover, the maintenance of physical activity during the care pathway in real-world settings is limited, highlighting the need for hybrid approaches that evaluate both clinical effectiveness and implementation. In response to these challenges, the primary study aim will be to compare the prevalence of musculoskeletal pain after six months of aromatase inhibitor therapy between patients initiating a personalized adapted physical activity program at the beginning of the care pathway and those receiving usual care. Secondary aims will be to (1) assess additional effects of the intervention on physical health, psychosocial well-being and treatment adherence, (2) explore contextual factors influencing program implementation in routine oncology care and (3) identify potential risk factors for the development of AIMSS. The APIS study is a hybrid type I effectiveness-implementation randomized controlled trial including 182 postmenopausal women with non-metastatic hormone-sensitive breast cancer. APIS will generate new evidence on the clinical and implementation effectiveness of early personalized APA (Adapted Physical Activity) in preventing AIMSS. The hybrid design will support the development of sustainable, patient-centered interventions, potentially improving quality of life, adherence to AI therapy and long-term outcomes in breast cancer survivorship.
Ancillary study (Groupement Hospitalier Nord, Hospices Civils de Lyon) The humero-scapulo-thoracic region is particularly exposed to functional alterations during the course of care of patients treated for breast cancer. In addition to the loss of strength and mobility associated with surgical and medical treatment, the shoulder can also be the site of pain due to AIMSS or PMDS (Post-Mastectomy Pain Syndrome).
These pains are often studied separately, depending on the treatment, but few studies offer a global vision of the functional evolution of the shoulder throughout the course of care, enabling prevention and adjustment of management. It is also relevant to assume that early APA treatment could improve functional rehabilitation in this area.
The aim of this study is therefore to evaluate the impact of an APA assessment and early referral to a personalized program (APIS protocol) on shoulder functionality, depending on the time of intervention in the therapeutic pathway.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Quantitative study:
- •Women aged 18 to 75
- •Person with non-metastatic breast cancer
- •positive for at least one hormone receptor
- •Person treated with an Aromatase Inhibitor
- •Person with the following treatment regimen: Surgery - radiotherapy - aromatase inhibitor hormone therapy or surgery - chemotherapy (neoadjuvant or adjuvant) +/- targeted therapy - +/- radiotherapy - aromatase inhibitor hormone therapy.
- •Person affiliated to a social security scheme
- •Person having signed a free and informed consent
- •Qualitative study:
- •For patients :
- •Patient having given consent to participate in the APIS study
- •Patient agreeing to participate in the qualitative study (box checked on the APIS informed consent form)
- •Patient agreeing to the recording of the semi-directive interview
- •For healthcare professionals :
- •Person practicing within the Saint-Étienne University Hospital and the Croix-Rousse University Hospital as a surgeon, oncologist, radiotherapist, sports medicine physician, APA instructor, physiotherapist, head nurse, care coordinator nurse, or advanced practice nurse
- •Persons working with patients treated with aromatase inhibitors for non-metastatic breast cancer
- •Person who has received individual information
- •Person who has given consent to participate in the study
- •Person agreeing to the recording of the semi-directive interview
- •Person of legal age
- •Ancillary study :
- •Eligible patient who has given consent to participate in the APIS study
- •Patient agreeing to participate in the ancillary study (box checked on the APIS informed consent form)
排除标准
- •For all patients:
- •Person deprived of liberty by judicial or administrative decision
- •Person under psychiatric care (unstable pathology)
- •Person of full age under legal protection (guardianship, curatorship)
- •Person unable to receive sufficient information due to impaired higher functions, or insufficient command of the French language
- •Person participating in another interventional research study with an exclusion period still in progress at the time of pre-inclusion
- •Person with absolute contraindications to physical exercise:
- •Unstable angina
- •Decompensated heart failure
- •Complex ventricular rhythm disorders
- •Uncontrolled severe arterial hypertension
- •Pulmonary arterial hypertension (> 60 mm Hg)
- •Presence of large or pedunculated intracavitary thrombus
- •Acute pericardial effusion
- •Severe obstructive cardiomyopathy
- •Tight and/or symptomatic aortic stenosis
- •Recent thrombophlebitis with or without pulmonary embolism
- •Diabetes with plantar perforator disease for physical activity activities involving the lower limbs
- •Persons with musculoskeletal pathologies making cycling impossible
研究组 & 干预措施
Adapted Physical Activity started early (announcement)
The APA (Adapted Physical Activity) program is decided during the initial assessment.
干预措施: Adapted Physical Activity started early (Behavioral)
Adapted Physical Activity begins at the start of hormone therapy (control group).
Patients will receive standard care. The personalized APA (Adapted Physical Activity) protocol will begin at the same time as hormone therapy. Hormone therapy is initiated at the end of primary treatment and continues during the survivorship care period.
干预措施: Adapted Physical Activity begins at the start of hormone therapy (Behavioral)
结局指标
主要结局
Score of most intense musculoskeletal pain
时间窗: 6 months after introduction of hormone therapy
To analyze the impact of implementing a specific APA program, right from the start of treatment, on the prevalence of musculoskeletal pain experienced by patients treated for breast cancer with aromatase inhibitors (AI) after 6 months of hormone therapy (peak of symptoms). Musculoskeletal pain are measured using the Nordic-type questionnaire. This score is measured using the Nordic questionnaire, which includes a Numerical Rating Scale (NRS) for musculoskeletal pain ranging from 0 to 10: * 0 = no pain or discomfort * 10 = intolerable pain or discomfort A higher score reflects a more unfavorable clinical outcome.
次要结局
- Score of European Health Literacy Survey Questionnaire's short version (HLS-EU-Q16)(At the inclusion (V0))
- Score of eHealth Literacy Scale (eHEALS)(At the inclusion (V0))
- Evolution of musculoskeletal pain intensity(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Score of global pain(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Evaluation of Quality of life(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Fatigue(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Anxiety(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Cognitive complaints(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Physical condition(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Weight(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Program-level adaptations made during the implementation of the Adapted Physical Activity (APA) intervention(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Height(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Body Mass Index (BMI)(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Percentage of body fat(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Malnutrition Universal Screening Tool (MUST) score(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- GIRERD score(T2 (6 months after initiation of the Aromatase Inhibitors))
- Waist circumference(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Metabolic syndrome(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Heart rate variability(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Adverse events related to the intervention(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Percentage of patients who completed all stages of the study(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Proportion of healthcare professionals involved in the delivery of the APA program(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Average number of Adapted Physical Activity (APA) sessions per week(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Intensity level of Physical Activity (PA) session(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Average duration of Adapted Physical Activity (APA) sessions(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Proportion of sessions complying with the type of exercise recommended by guidelines(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Motivation scale towards health-oriented physical activity (EMAPS) total score(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Patient satisfaction with the proposed Adapted Physical Activity (APA) program(From the initial phase to 6 months after the introduction of Aromatase Inhibitors.)
- Type of Physical Activity performed after the supervised Adapted Physical Activity (APA) program period(6 months after the introduction of Aromatase Inhibitors)
- Intensité of Physical Activity performed after the supervised Adapted Physical Activity (APA) program period(6 months after the introduction of Aromatase Inhibitors)
- Frequency of Physical Activity performed after the supervised Adapted Physical Activity (APA) program period(6 months after the introduction of Aromatase Inhibitors)
- Barriers to the long-term integration of Physical Activity (PA) into daily life and clinical practice(6 months after the introduction of Aromatase Inhibitors)
- Facilitators to the long-term integration of Physical Activity (PA) into daily life and clinical practice(6 months after the introduction of Aromatase Inhibitors)
- Duration of Physical Activity (PA) performed after the supervised Adapted Physical Activity (APA) program period(6 months after the introduction of Aromatase Inhibitors)