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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapted Physical Activity started early (announcement) | Experimental | The APA (Adapted Physical Activity) program is decided during the initial assessment. |
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| Adapted Physical Activity begins at the start of hormone therapy (control group). | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted Physical Activity started early | Behavioral | The Adapted Physical Activity program is decided during the initial assessment. The total duration of the rehabilitation protocol is 12 weeks, with 2 one-hour sessions per week. The rehabilitation protocol chosen in this study is mixed, i.e. it combines :
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| Measure | Description | Time Frame |
|---|---|---|
| Score of most intense musculoskeletal pain | 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:
| 6 months after introduction of hormone therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of musculoskeletal pain intensity | Musculoskeletal pain is measuring using the evolution of the score of the Nordic Musculoskeletal Questionnaire. The score was compare between pre-therapy and 6 months of hormone therapy in experimental and control groups. The Nordic Musculoskeletal Questionnaire including a Numerical Rating Scale (range 0 - 10), with higher scores indicating more severe pain. |
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Inclusion Criteria:
Quantitative study:
Qualitative study:
For patients :
For healthcare professionals :
Ancillary study :
Exclusion Criteria:
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:
Persons with musculoskeletal pathologies making cycling impossible
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marion CORTET, MD | Contact | 472 071 936 | +33 | marion.cortet@chu-lyon.fr |
| Nathalie PIAZZON, Nurse | Contact | 472 071 266 | +33 | nathalie.piazzon@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Gynécologie-Obstétrique, Groupement Hospitalier Nord, Hospices Civils de Lyon | Recruiting | Lyon | 69317 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42158292 | Derived | Piazzon N, Verot E, Gerard A, Baudot A, Carrouel F, Cortet M. Early adapted physical activity to prevent and manage aromatase inhibitor-induced musculoskeletal pain in breast cancer: protocol for a hybrid effectiveness-implementation randomised controlled trial (APIS). BMJ Open Sport Exerc Med. 2026 May 14;12(2):e003179. doi: 10.1136/bmjsem-2025-003179. eCollection 2026. |
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The APIS study is a hybrid Type 1 Effectiveness-Implementation randomized clinical trial that combines the evaluation of:
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| Adapted Physical Activity begins at the start of hormone therapy | Behavioral | Adapted Physical Activity begins at the start of hormone therapy The total duration of the rehabilitation protocol is 12 weeks, with 2 one-hour sessions per week. The rehabilitation protocol chosen in this study is mixed, i.e. it combines :
|
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| From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Score of global pain | Global pain is measured using the numerical scale. The numerical scale is a self-assessment scale and consists of asking the patient to quantify her overall pain at the present moment on a virtual scale ranging from 0 (no pain) to 10 (maximum imaginable pain). The aim is to compare the effects of the intervention on overall health outcomes, including physical health and psychosocial well-being. | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Evaluation of Quality of life | Quality of life is measured using FACT-B (Functional Assessment of Cancer Therapy - Breast) scale associated with the endocrine subscale (ES). FACT-B scale is a validated instrument designed to assess health-related quality of life in patients with breast cancer. It includes 37 items covering five domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and breast cancer-specific concerns. Each item is rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("very much"). Scores are summed to yield a total FACT-B score ranging from 0 to 148, with higher scores indicating better quality of life. Endocrine subscale (ES) specifically assesses endocrine symptoms and includes 19 quantifiable items such as hot flushes, weight gain and joint pain. Items are scored using the same 0-4 Likert scale, resulting in a total ES score ranging from 0 to 76, with higher scores reflecting fewer endocrine symptoms and better quality of life. | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Fatigue | Fatigue is measured using FACIT Fatigue - version 4- (Functional Assessment of Chronic Illness Therapy - Fatigue) Scale. The aim is to compare the effects of the intervention on overall health outcomes, including physical health and psychosocial well-being. Patients respond using a 5-point Likert scale. Each response is scored from 0 ("not at all") to 4 ("very much"). The scoring system reverses the numbers for negative items. This means that for 11 items with negative statements (such as "I feel tired"), a 4 becomes a 0 and a 3 becomes a 1. Adding the 13 scores gives a total between 0 and 52 points. Higher total scores mean less fatigue and a better quality of life. Scores below 30 indicate severe fatigue. | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Anxiety | Anxiety is measured using HAD (Hospital Anxiety and Depression) scale.The aim is to compare the effects of the intervention on overall health outcomes, including physical health and psychosocial well-being. The HAD scale is a tool used to screen for anxiety and depressive disorders. It consists of 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to depression (total D), thus yielding two scores (maximum score for each = 21). Interpretation: To screen for anxiety and depression symptoms, the following interpretation can be used for each score (A and D):
| From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Cognitive complaints | Cognitive complaints are measured using FACT-Cognitive Function -version 3 (Functional Assessment of Cancer Therapy - Cognitive Function) scale. The aim is to compare the effects of the intervention on overall health outcomes, including physical health and psychosocial well-being. The FACT-G comprises four subscales: physical well-being (PWB; 7 items, score range 0-28), social/family well-being (SWB; 7 items, score range 0-28), emotional well-being (EWB; 6 items, score range 0-24), and functional well-being (FWB; 7 items, score range 0-28). Negatively worded items are reverse-scored before summation, so that higher subscale and total scores indicate better self-reported cognitive functioning. | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Physical condition | Physical condition is measuring using the 6-minute walk test. The score (between 375 and 546) was compare between pre-therapy and 6 months of hormone therapy in experimental and control groups (higher score mean a better outcome). | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Weight | Body composition is assessed by weight (kg), height (cm), Body Mass Index (BMI = weight/height in meters squared), waist circumference, measurement of the four skinfolds (validated measurement for assessing adiposity: % body fat) and malnutrition screening (Malnutrition Universal Screening Tool - MUST). Weight is measured in kilograms | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Height | Body composition is assessed by weight (kg), height (cm), Body Mass Index (BMI = weight/height in meters squared), waist circumference, measurement of the four skinfolds (validated measurement for assessing adiposity: % body fat) and malnutrition screening (Malnutrition Universal Screening Tool - MUST). Height is measured in centimeters | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Body Mass Index (BMI) | Body composition is assessed by weight (kg), height (cm), Body Mass Index (BMI = weight/height in meters squared), waist circumference, measurement of the four skinfolds (validated measurement for assessing adiposity: % body fat) and malnutrition screening (Malnutrition Universal Screening Tool - MUST). Body Mass Index (BMI)
| From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Waist circumference | Body composition is assessed by weight (kg), height (cm), Body Mass Index (BMI = weight/height in meters squared), waist circumference, measurement of the four skinfolds (validated measurement for assessing adiposity: % body fat) and malnutrition screening (Malnutrition Universal Screening Tool - MUST). Waist circumference
| From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Percentage of body fat | Body composition is assessed by weight (kg), height (cm), Body Mass Index (BMI = weight/height in meters squared), waist circumference, measurement of the four skinfolds (validated measurement for assessing adiposity: % body fat) and malnutrition screening (Malnutrition Universal Screening Tool - MUST). Percentage of body fat:
| From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Malnutrition Universal Screening Tool (MUST) score | Body composition is assessed by weight (kg), height (cm), Body Mass Index (BMI = weight/height in meters squared), waist circumference, measurement of the four skinfolds (validated measurement for assessing adiposity: % body fat) and malnutrition screening (Malnutrition Universal Screening Tool - MUST). Risk of malnutrition (MUST) The risk of malnutrition will be assessed using the Malnutrition Universal Screening Tool (MUST). The total MUST score ranges from 0 to ≥ 2, with higher scores indicating an increased risk of malnutrition (0 = low risk; 1 = intermediate risk; ≥ 2 = high risk). | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Metabolic syndrome | It is defined according to international recommendations (International Diabetes Federation). Diagnosis is established when at least 3 of the following criteria are present:
HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) index is used to estimate insulin resistance, a key underlying mechanism of metabolic syndrome and an early marker of impaired glucose metabolism | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Heart rate variability | Heart rate is measured by ECG (Electrocardiogram) Holter over the night period at T0 and T2 | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| GIRERD score | GIRERD questionnaire is used to evaluate therapeutic adherence of patient to the Aromatase Inhibitors. GIRERD score; 0-6; higher score = poorer adherence | T2 (6 months after initiation of the Aromatase Inhibitors) |
| Adverse events related to the intervention | Assessment of the occurrence of adverse events secondary to the intervention at T1 (only for the experimental group), TAPA and T2 | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Percentage of patients who completed all stages of the study | The contextual factors influencing the implementation of the APA program in real-world oncology care are evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. All 5 RE-AIM dimensions will be examined to capture key factors influencing real-world applicability, using a combination of quantitative and qualitative data collected from participants and healthcare professionals The first RE-AIM dimension is represented by the proportion and representativeness of individuals in the target population who participated in the intervention evaluated by percentage of patients who completed all stages of the study, dropout rate at each key stage of the study, reasons for dropout | 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 | The contextual factors influencing the implementation of the APA program in real-world oncology care are evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. All 5 RE-AIM dimensions will be examined to capture key factors influencing real-world applicability, using a combination of quantitative and qualitative data collected from participants and healthcare professionals The third RE-AIM dimension is represented by Adoption evaluated by the engagement of individual healthcare professionals in delivering the intervention: proportion of healthcare professionals involved in the delivery of the APA program, by specialty, relative to the total number of eligible professionals at each participating site | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Average number of Adapted Physical Activity (APA) sessions per week | Fidelity of intervention is evaluated by the average number of APA sessions per week recorded throughout the intervention period using the electronic medical record. Unit of measure: sessions per week. Interpretation: higher values indicate greater adherence and fidelity to the intervention. | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Intensity level of Physical Activity (PA) session | Fidelity of intervention is evaluated by the intensity level of PA sessions measured by a perceived exertion scale (Borg Rating of Perceived Exertion (RPE) scale) and objective data Unit of measure: Borg RPE scale score. Higher scores indicate higher exercise intensity. | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Average duration of Adapted Physical Activity (APA) sessions | Fidelity of intervention is evaluated by the average duration of APA sessions is recorded during the intervention period using the electronic medical record. Unit of measurement: minutes per session. The higher the value, the longer the session. | 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 | Fidelity of intervention is evaluated by proportion of sessions complying with the type of exercise recommended by guidelines. Unit of measure: percentage (%). Higher values indicate greater fidelity. | 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 | Fidelity of intervention is evaluated by program-level adaptations made during the implementation of the APA intervention. This outcome is descriptive and qualitative. | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Motivation scale towards health-oriented physical activity (EMAPS) total score | Fidelity of intervention is evaluated by motivation toward APA assessed using the motivation scale towards health-oriented physical activity (EMAPS). Unit of measure: EMAPS total score. Interpretation: higher scores indicate higher motivation toward APA. | From the initial phase to 6 months after the introduction of Aromatase Inhibitors. |
| Patient satisfaction with the proposed Adapted Physical Activity (APA) program | Fidelity of intervention is evaluated by patient satisfaction with the proposed APA program assessed using a self-administered Likert scale. Unit of measure: Likert scale score from 0 to 10 Interpretation: higher scores indicate greater satisfaction with the 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 | Sustainability of PA behavior after the APA intervention is assessed at the individual level using a daily PA logbook completed by participants beyond the supervised APA program period. The logbook collects the following parameters daily:
Interpretation: higher frequency, longer duration, and higher perceived intensity of PA indicate greater sustainability of behavior change. | 6 months after the introduction of Aromatase Inhibitors |
| Intensité of Physical Activity performed after the supervised Adapted Physical Activity (APA) program period | Sustainability of PA behavior after the APA intervention is assessed at the individual level using a daily PA logbook completed by participants beyond the supervised APA program period. The logbook collects the following parameters daily:
Interpretation: higher frequency, longer duration, and higher perceived intensity of PA indicate greater sustainability of behavior change. | 6 months after the introduction of Aromatase Inhibitors |
| Duration of Physical Activity (PA) performed after the supervised Adapted Physical Activity (APA) program period | Sustainability of PA behavior after the APA intervention is assessed at the individual level using a daily PA logbook completed by participants beyond the supervised APA program period. The logbook collects the following parameters daily:
Interpretation: higher frequency, longer duration, and higher perceived intensity of PA indicate greater sustainability of behavior change. | 6 months after the introduction of Aromatase Inhibitors |
| Frequency of Physical Activity performed after the supervised Adapted Physical Activity (APA) program period | Sustainability of PA behavior after the APA intervention is assessed at the individual level using a daily PA logbook completed by participants beyond the supervised APA program period. The logbook collects the following parameters daily:
Interpretation: higher frequency, longer duration, and higher perceived intensity of PA indicate greater sustainability of behavior change. | 6 months after the introduction of Aromatase Inhibitors |
| Barriers to the long-term integration of Physical Activity (PA) into daily life and clinical practice | Barriers to the long-term integration of PA into daily life and clinical practice are explored using data collected as part of the qualitative study, through semi-structured interviews conducted with patients at T2 (6 months after initiation of the Aromatase Inhibitors) and with healthcare professionals. | 6 months after the introduction of Aromatase Inhibitors |
| Facilitators to the long-term integration of Physical Activity (PA) into daily life and clinical practice | Facilitators to the long-term integration of PA into daily life and clinical practice are explored using data collected as part of the qualitative study, through semi-structured interviews conducted with patients at T2 (6 months after initiation of the Aromatase Inhibitors) and with healthcare professionals. | 6 months after the introduction of Aromatase Inhibitors |
| Score of European Health Literacy Survey Questionnaire's short version (HLS-EU-Q16) | The HLS-EU-Q16 is a 16-item validated questionnaire assessing health literacy in the general population. It evaluates individuals' perceived difficulty in accessing, understanding, appraising, and applying health-related information across three domains: healthcare, disease prevention, and health promotion. Responses are rated on a 4-point Likert scale from "very easy" to "very difficult". The total score ranges from 0 to 16, with higher scores indicating better health literacy. | At the inclusion (V0) |
| Score of eHealth Literacy Scale (eHEALS) | The eHealth Literacy Scale (eHEALS) is an 8-item validated self-reported questionnaire assessing individuals' perceived skills at finding, evaluating, and applying electronic health information. Items are rated on a 5-point Likert scale from "strongly disagree" to "strongly agree". The total score ranges from 8 to 40, with higher scores indicating greater eHealth literacy. | At the inclusion (V0) |
| Service de Chirurgie Gynécologie-Obstétrique,CHU Hôpital Nord | Not yet recruiting | Saint-Priest-en-Jarez | 42270 | France |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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