Breast CancerAPISNCT07295457
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 (APIS)
A study testing Adapted Physical Activity started early and Adapted Physical Activity begins at the start of hormone therapy in people with Breast Cancer, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Adapted Physical Activity started early and Adapted Physical Activity begins at the start of hormone therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 2 sitesFrance
- Study dates
- 21 May 2026to Jul 2029
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Service de Gynécologie-Obstétrique, Groupement Hospitalier Nord, Hospices Civils de Lyon
Lyon, 69317
Marion CORTET, MD
Nathalie PIAZZON, Nurse
- Not yet recruiting
Service de Chirurgie Gynécologie-Obstétrique,CHU Hôpital Nord
Saint-Priest-en-Jarez, 42270
Céline CHAULEUR, MD
Céline CHAULEUR, MD
About this study
Official title: 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
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).
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- Adapted Physical Activity started early, Adapted Physical Activity begins at the start of hormone therapy
- Keywords
- Breast cancer, Hormonotherapy, Musculoskeletal pain, Adapted physical activity, Aromatase inhibitors, Exercise oncology, Implementation science
- Medical subject headings
- Breast Neoplasms, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical Activity started earlyBehavioural
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 :
- Exercise training on ergocyclometer or treadmill
- Flexibility and muscle-strengthening work supervised by a physiotherapist
- Free work with the APA practitioner
Adapted Physical Activity begins at the start of hormone therapyBehavioural
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 :
- Exercise training on ergocyclometer or treadmill
- Flexibility and muscle-strengthening work supervised by a physiotherapist
- Free work with the APA practitioner
| Study group | Role | What they receive |
|---|---|---|
| Adapted Physical Activity started early (announcement) | Experimental | The APA (Adapted Physical Activity) program is decided during the initial assessment. Receives: Behavioral: Adapted Physical Activity started early |
| 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. Receives: Behavioral: Adapted Physical Activity begins at the start of hormone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 0 = no pain or discomfort
- 10 = intolerable pain or discomfort A higher score reflects a more unfavorable clinical outcome.
Measured: 6 months after introduction of hormone therapy
Secondary outcomes (34)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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):
- 7 or less: no symptoms
- 8 to 10: possible symptoms
- 11 or more: definite symptoms.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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)
- Description: BMI will be calculated by dividing weight (kg) by height (m)². Weight and height will be measured according to standardized procedures, but only BMI will be reported as an outcome measure, as these data are collected solely for its calculation.
- Unit of measurement: kg/m²
- Interpretation: Higher values reflect greater adiposity.
Measured: 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
- Description: Waist circumference will be measured in centimeters.
- Unit of measurement: cm
- Interpretation: Higher values are associated with greater central adiposity.
Measured: 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:
- Description: The percentage of body fat will be estimated from four skinfolds using a validated equation.
- Unit of measurement: %
- Interpretation: Higher percentages indicate greater adiposity.
Measured: 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).
Measured: 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:
- Abdominal obesity: waist circumference > 80cm in women
- Elevated triglycerides: fasting triglycerides > 1.7mmol/L or current treatment for hypertriglyceridemia
- Reduced HDL-cholesterol: < 1.29 mmol/L in women or current treatment to increase HDL-cholesterol
- Elevated blood pressure: systolic blood pressure ≥ 130mmHg and/or diastolic blood pressure ≥ 85mmHg or current antihypertensive treatment
- Elevated fasting glucose: fasting plasma glucose ≥ 5.6mmol/L according to ADA criteria, (Note: older definitions used a threshold of ≥ 6.1mmol/L) or current treatment for type 2 diabetes or hyperglycemia
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- Type of PA performed (e.g., walking, cycling, strengthening, flexibility exercises)
- Intensity of PA, assessed using the Borg Rating of Perceived Exertion scale
- Duration of PA expressed in minutes per session
- Frequency of PA defined as the number of PA sessions per day and per week.
Interpretation: higher frequency, longer duration, and higher perceived intensity of PA indicate greater sustainability of behavior change.
Measured: 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:
- Intensity of PA, assessed using the Borg Rating of Perceived Exertion scale (Unit of measure: Borg RPE scale score.Higher scores indicate higher exercise intensity)
- Type of PA performed (e.g., walking, cycling, strengthening, flexibility exercises)
- Duration of PA expressed in minutes per session
- Frequency of PA defined as the number of PA sessions per day and per week.
Interpretation: higher frequency, longer duration, and higher perceived intensity of PA indicate greater sustainability of behavior change.
Measured: 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:
- Duration of PA expressed in minutes per session
- Type of PA performed (e.g., walking, cycling, strengthening, flexibility exercises)
- Intensity of PA, assessed using the Borg Rating of Perceived Exertion scale
- Frequency of PA defined as the number of PA sessions per day and per week.
Interpretation: higher frequency, longer duration, and higher perceived intensity of PA indicate greater sustainability of behavior change.
Measured: 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:
- Frequency of PA defined as the number of PA sessions per day and per week.
- Type of PA performed (e.g., walking, cycling, strengthening, flexibility exercises)
- Intensity of PA, assessed using the Borg Rating of Perceived Exertion scale
- Duration of PA expressed in minutes per session
Interpretation: higher frequency, longer duration, and higher perceived intensity of PA indicate greater sustainability of behavior change.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the inclusion (V0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start21 May 2026
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Model description
- The APIS study is a hybrid Type 1 Effectiveness-Implementation randomized clinical trial that combines the evaluation of: * The effectiveness of an APA program on AIMSS : multicenter, controlled, randomized, 2-parallel group, open-label, prospective, minimal risk and constraint interventional clinical research study. * Implementation, exploring, using the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) theoretical framework, its adoption, accessibility, practical integration into care pathways, and sustainability in different settings.
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295457
- Sponsor's protocol ID
- 69HCL24_0748
- Acronym
- APIS
- Status last verified
- Jul 2026
- First submitted
- 26 Sep 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 42158292
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07295457
- Acronym / sponsor ID
- APIS / 69HCL24_0748
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Hormonotherapy, Musculoskeletal pain, Adapted physical activity, Aromatase inhibitors, Exercise oncology, Implementation science
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 May 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 19 Dec 2025 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The APIS study is a hybrid Type 1 Effectiveness-Implementation randomized clinical trial that combines the evaluation of: * The effectiveness of an APA program on AIMSS : multicenter, controlled, randomized, 2-parallel group, open-label, prospective, minimal risk and constraint interventional clinical research study. * Implementation, exploring, using the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) theoretical framework, its adoption, accessibility, practical integration into care pathways, and sustainability in different settings.
| Arm | Type | Receives |
|---|---|---|
| Adapted Physical Activity started early (announcement) | Experimental | Behavioral: Adapted Physical Activity started earlyThe APA (Adapted Physical Activity) program is decided during the initial assessment. |
| Adapted Physical Activity begins at the start of hormone therapy (control group). | Active comparator | Behavioral: Adapted Physical Activity begins at the start of hormone therapyPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
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 |
|---|---|---|
| Adapted Physical Activity started earlyThe 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 : * Exercise training on ergocyclometer or treadmill * Flexibility and muscle-strengthening work supervised by a physiotherapist * Free work with the APA practitioner | Behavioural | Adapted Physical Activity started early (announcement) |
| Adapted Physical Activity begins at the start of hormone therapyAdapted 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 : * Exercise training on ergocyclometer or treadmill * Flexibility and muscle-strengthening work supervised by a physiotherapist * Free work with the APA practitioner | Behavioural | Adapted Physical Activity begins at the start of hormone therapy (control group). |
Primary outcome
Score of most intense musculoskeletal pain
Time frame: 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.
34 secondary outcomes
Evolution of musculoskeletal pain intensity
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Score of global pain
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Evaluation of Quality of life
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Fatigue
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Anxiety
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Cognitive complaints
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Physical condition
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Weight
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Height
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Body Mass Index (BMI)
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Waist circumference
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Percentage of body fat
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Malnutrition Universal Screening Tool (MUST) score
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Metabolic syndrome
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Heart rate variability
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
GIRERD score
Time frame: T2 (6 months after initiation of the Aromatase Inhibitors)
Adverse events related to the intervention
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Percentage of patients who completed all stages of the study
Time frame: 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
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Average number of Adapted Physical Activity (APA) sessions per week
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Intensity level of Physical Activity (PA) session
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Average duration of Adapted Physical Activity (APA) sessions
Time frame: 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
Time frame: 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
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Motivation scale towards health-oriented physical activity (EMAPS) total score
Time frame: From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Patient satisfaction with the proposed Adapted Physical Activity (APA) program
Time frame: 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
Time frame: 6 months after the introduction of Aromatase Inhibitors
Intensité of Physical Activity performed after the supervised Adapted Physical Activity (APA) program period
Time frame: 6 months after the introduction of Aromatase Inhibitors
Duration of Physical Activity (PA) performed after the supervised Adapted Physical Activity (APA) program period
Time frame: 6 months after the introduction of Aromatase Inhibitors
Frequency of Physical Activity performed after the supervised Adapted Physical Activity (APA) program period
Time frame: 6 months after the introduction of Aromatase Inhibitors
Barriers to the long-term integration of Physical Activity (PA) into daily life and clinical practice
Time frame: 6 months after the introduction of Aromatase Inhibitors
Facilitators to the long-term integration of Physical Activity (PA) into daily life and clinical practice
Time frame: 6 months after the introduction of Aromatase Inhibitors
Score of European Health Literacy Survey Questionnaire's short version (HLS-EU-Q16)
Time frame: At the inclusion (V0)
Score of eHealth Literacy Scale (eHEALS)
Time frame: At the inclusion (V0)
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 31 Jul 2026.
- Derived from this study: PubMed 42158292Piazzon 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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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity started early and Adapted Physical Activity begins at the start of hormone therapy in people with Breast Cancer, run by Hospices Civils de Lyon at 2 sites in France.
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 23 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Marion CORTET, MD (472 071 936 ext. +33, marion.cortet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of most intense musculoskeletal pain (time frame: 6 months after introduction of hormone therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07295457, which also lists 1 linked publication.
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 31 Jul 2026.