Breast CancerAPECSNCT05677022
Evaluation of the Interest of a Postural and Functional Analysis for the Follow-up of the Adapted Motor Activity of Patients Treated for Breast Cancer
A study testing Adapted motor activity in people with Breast Cancer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The goal of this clinical trial is to evaluate the acceptability by patients treated for breast cancer of an adapted motor activity program over a period of 15 months controlled by a postural and functional analysis.. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Adapted motor activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult woman, having given her consent to participate in the study,
- Patient with non-metastatic breast cancer,
- Cancer to be treated by surgery with or without adjuvant treatment (radiotherapy and/or chemotherapy).
Who cannot join
- Contraindication to the practice of a physical activity,
- Mental deficiency or any other reason that could hinder the understanding or the strict application of the protocol,
- Patient not affiliated to the French social security system,
- Patient under legal protection, guardianship or curatorship,
- Patient already included in another therapeutic study protocol aimed at evaluating the benefits of adapted physical activity.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clairval Hospital Center
Marseille, 13009
Emilie Bialecki, PHD, 491171428, emilie.bialecki@outlook.fr
Cyril FOA, MD
About this study
The goal of this clinical trial is to evaluate the acceptability by patients treated for breast cancer of an adapted motor activity program over a period of 15 months controlled by a postural and functional analysis..
Participant population/health conditions: patients with newly operated breast cancer who are candidates for an adapted physical activity program
Read the detailed description
This is a prospective, longitudinal, single-center, open-label study of a population of newly operated breast cancer patients who were candidates for an adapted motor activity program.
All included patients will be followed for a period of 15 months. Participating physicians will have the opportunity to recruit their patients during the 24 months following the study's initiation. The study will be completed once the last included patient has a final evaluation. The total duration of the study is 39 months (24 months of recruitment and 15 months of follow-up).
Each patient will be assessed four times: at inclusion before initiation of cancer treatment, and at M3, M9 and M15. At each patient visit with the investigating physician, an assessment will be completed on the electronic CRF by the physician or by the site CRA under the responsibility of the investigating physician.
- Conditions
- Breast Cancer
- Being tested
- Adapted motor activity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted motor activityOther
15-month adapted motor activity program based on a postural and functional analysis
| Study group | Role | What they receive |
|---|---|---|
| Adapted motor activity | Experimental | Not described Receives: Other: Adapted motor activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of compliance
Patients will be considered compliant if they have attended more than 50% of the physical adaptation program sessions
Measured: Month 15
Secondary outcomes (23)
Assessment of the functional impact of the disease
The Primus is used to establish a score during the performance of a movement. The number and nature of the movements evaluated are independent from one patient to another, nevertheless 4 very precise movements will be carried out in all the patients included in this study: ironing, vacuuming, driving and the hand-grip. The tests performed on the same patient will be strictly identical from one examination to the next.
A Primus score will be calculated for each gesture. A global score will be calculated for each patient. It corresponds to the total score obtained by the patient divided by the number of tests performed.
For each test and for the global score, the score recorded at Day 0 will constitute the reference value. The evolution of the scores during the follow-up will be expressed as a percentage of variation in relation to this basal score.
Measured: Month 3
Assessment of the functional impact of the disease
The Primus is used to establish a score during the performance of a movement. The number and nature of the movements evaluated are independent from one patient to another, nevertheless 4 very precise movements will be carried out in all the patients included in this study: ironing, vacuuming, driving and the hand-grip. The tests performed on the same patient will be strictly identical from one examination to the next.
A Primus score will be calculated for each gesture. A global score will be calculated for each patient. It corresponds to the total score obtained by the patient divided by the number of tests performed.
For each test and for the global score, the score recorded at D0 will constitute the reference value. The evolution of the scores during the follow-up will be expressed as a percentage of variation in relation to this basal score.
Measured: Month 9
Assessment of the functional impact of the disease
The Primus is used to establish a score during the performance of a movement. The number and nature of the movements evaluated are independent from one patient to another, nevertheless 4 very precise movements will be carried out in all the patients included in this study: ironing, vacuuming, driving and the hand-grip. The tests performed on the same patient will be strictly identical from one examination to the next.
A Primus score will be calculated for each gesture. A global score will be calculated for each patient. It corresponds to the total score obtained by the patient divided by the number of tests performed.
For each test and for the global score, the score recorded at D0 will constitute the reference value. The evolution of the scores during the follow-up will be expressed as a percentage of variation in relation to this basal score.
Measured: Month 15
Postural evaluation
The postural evaluation will be carried out using a force platform with strain gauges as sensors, allowing to measure the moment of the vertical force exerted on the plate, and to locate the center of pressure of the feet and to record the variations on the antero-posterior and lateral axes.
The dual-tray platform used in the study allows separate assessment of the forces exerted under each of the lower limbs.
Measured: Month 3
Postural evaluation
The postural evaluation will be carried out using a force platform with strain gauges as sensors, allowing to measure the moment of the vertical force exerted on the plate, and to locate the center of pressure of the feet and to record the variations on the antero-posterior and lateral axes.
The dual-tray platform used in the study allows separate assessment of the forces exerted under each of the lower limbs.
Measured: Month 9
Postural evaluation
The postural evaluation will be carried out using a force platform with strain gauges as sensors, allowing to measure the moment of the vertical force exerted on the plate, and to locate the center of pressure of the feet and to record the variations on the antero-posterior and lateral axes.
The dual-tray platform used in the study allows separate assessment of the forces exerted under each of the lower limbs.
Measured: Month 15
Pain assessment
Pain intensity will be assessed using a simple numerical scale (SNS) graduated from 0 (no pain) to 10 (worst pain imaginable).
Measured: Month 3
Pain assessment
Pain intensity will be assessed using a simple numerical scale (SNS) graduated from 0 (no pain) to 10 (worst pain imaginable).
Measured: Month 9
Pain assessment
Pain intensity will be assessed using a simple numerical scale (SNS) graduated from 0 (no pain) to 10 (worst pain imaginable).
Measured: Month 15
Functional and mobility assessment of the shoulder
This evaluation will be carried out using the Constant questionnaire composed of 11 questions grouped into 4 items (pain, activities of daily living, mobility and power of the shoulder). A global score ranging from 0 to 100 is obtained (almost no function to normal function).
Measured: Month 3
Functional and mobility assessment of the shoulder
This evaluation will be carried out using the Constant questionnaire composed of 11 questions grouped into 4 items (pain, activities of daily living, mobility and power of the shoulder). A global score ranging from 0 to 100 is obtained (almost no function to normal function).
Measured: Month 9
Functional and mobility assessment of the shoulder
This evaluation will be carried out using the Constant questionnaire composed of 11 questions grouped into 4 items (pain, activities of daily living, mobility and power of the shoulder). A global score ranging from 0 to 100 is obtained (almost no function to normal function).
Measured: Month 15
Assessment of the emotional impact of the disease
The emotional impact of the disease will be more precisely evaluated by the HAD questionnaire, a screening tool for the most common manifestations of anxiety and depressive disorders to be completed by the patient. The scale consists of 14 questions, with 7 items assessing anxiety and 7 items assessing depression. A minimum score of 10 on one of the sub-scores was retained as a screening criterion for depressive or anxious manifestations.
Measured: Month 3
Assessment of the emotional impact of the disease
The emotional impact of the disease will be more precisely evaluated by the HAD questionnaire, a screening tool for the most common manifestations of anxiety and depressive disorders to be completed by the patient. The scale consists of 14 questions, with 7 items assessing anxiety and 7 items assessing depression. A minimum score of 10 on one of the sub-scores was retained as a screening criterion for depressive or anxious manifestations.
Measured: Month 9
Assessment of the emotional impact of the disease
The emotional impact of the disease will be more precisely evaluated by the HAD questionnaire, a screening tool for the most common manifestations of anxiety and depressive disorders to be completed by the patient. The scale consists of 14 questions, with 7 items assessing anxiety and 7 items assessing depression. A minimum score of 10 on one of the sub-scores was retained as a screening criterion for depressive or anxious manifestations.
Measured: Month 15
Assessment of the impact of the disease on quality of life
Patients' quality of life will be assessed by completing the EORTC Core Quality of Life Questionnaire EORTC QLQ-C30 questionnaire with 30 questions
Measured: Month 3
Assessment of the impact of the disease on quality of life
Patients' quality of life will be assessed by completing the EORTC Core Quality of Life Questionnaire EORTC QLQ-Br 23 module with 23 additional questions.
Measured: Month 3
Assessment of the impact of the disease on quality of life
Patients' quality of life will be assessed by completing the EORTC Core Quality of Life Questionnaire EORTC QLQ-C30 questionnaire with 30 questions
Measured: Month 9
Assessment of the impact of the disease on quality of life
Patients' quality of life will be assessed by completing the EORTC Core Quality of Life Questionnaire EORTC QLQ-Br 23 module with 23 additional questions.
Measured: Month 9
Assessment of the impact of the disease on quality of life
Patients' quality of life will be assessed by completing the EORTC Core Quality of Life Questionnaire EORTC QLQ-C30 questionnaire with 30 questions.
Measured: Month 15
Assessment of the impact of the disease on quality of life
Patients' quality of life will be assessed by completing the EORTC Core Quality of Life Questionnaire EORTC QLQ-Br 23 module with 23 additional questions.
Measured: Month 15
Assessment of sarcopenia
Sarcopenia will be measured by impedancemetry. The parameters collected will be in kilograms.
Measured: Month 15
Assessment of sarcopenia
Sarcopenia will be measured by impedancemetry. The parameters collected will be in percentage.
Measured: Month 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, longitudinal, single-center, open-label study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677022
- Sponsor's protocol ID
- 2021-A03091-40
- Acronym
- APECS
- Status last verified
- Jun 2024
- First submitted
- 19 Dec 2022
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interest of a Postural and Functional Analysis for the Follow-up of the Adapted Motor Activity of Patients Treated for Breast Cancer
- ClinicalTrials.gov ID
- NCT05677022
- Acronym / sponsor ID
- APECS / 2021-A03091-40
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Jan 2023 (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.
The goal of this clinical trial is to evaluate the acceptability by patients treated for breast cancer of an adapted motor activity program over a period of 15 months controlled by a postural and functional analysis..
Participant population/health conditions: patients with newly operated breast cancer who are candidates for an adapted physical activity program
Detailed description
This is a prospective, longitudinal, single-center, open-label study of a population of newly operated breast cancer patients who were candidates for an adapted motor activity program.
All included patients will be followed for a period of 15 months. Participating physicians will have the opportunity to recruit their patients during the 24 months following the study's initiation. The study will be completed once the last included patient has a final evaluation. The total duration of the study is 39 months (24 months of recruitment and 15 months of follow-up).
Each patient will be assessed four times: at inclusion before initiation of cancer treatment, and at M3, M9 and M15. At each patient visit with the investigating physician, an assessment will be completed on the electronic CRF by the physician or by the site CRA under the responsibility of the investigating physician.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, longitudinal, single-center, open-label study
| Arm | Type | Receives |
|---|---|---|
| Adapted motor activity | Experimental | Other: Adapted motor activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult woman, having given her consent to participate in the study,
- Patient with non-metastatic breast cancer,
- Cancer to be treated by surgery with or without adjuvant treatment (radiotherapy and/or chemotherapy).
Key exclusion criteria (5 listed)
- Contraindication to the practice of a physical activity,
- Mental deficiency or any other reason that could hinder the understanding or the strict application of the protocol,
- Patient not affiliated to the French social security system,
- Patient under legal protection, guardianship or curatorship,
- Patient already included in another therapeutic study protocol aimed at evaluating the benefits of adapted physical activity.
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 motor activity15-month adapted motor activity program based on a postural and functional analysis | Other | Adapted motor activity |
Primary outcome
Assessment of compliance
Time frame: Month 15
Patients will be considered compliant if they have attended more than 50% of the physical adaptation program sessions
23 secondary outcomes
Assessment of the functional impact of the disease
Time frame: Month 3
Assessment of the functional impact of the disease
Time frame: Month 9
Assessment of the functional impact of the disease
Time frame: Month 15
Postural evaluation
Time frame: Month 3
Postural evaluation
Time frame: Month 9
Postural evaluation
Time frame: Month 15
Pain assessment
Time frame: Month 3
Pain assessment
Time frame: Month 9
Pain assessment
Time frame: Month 15
Functional and mobility assessment of the shoulder
Time frame: Month 3
Functional and mobility assessment of the shoulder
Time frame: Month 9
Functional and mobility assessment of the shoulder
Time frame: Month 15
Assessment of the emotional impact of the disease
Time frame: Month 3
Assessment of the emotional impact of the disease
Time frame: Month 9
Assessment of the emotional impact of the disease
Time frame: Month 15
Assessment of the impact of the disease on quality of life
Time frame: Month 3
Assessment of the impact of the disease on quality of life
Time frame: Month 3
Assessment of the impact of the disease on quality of life
Time frame: Month 9
Assessment of the impact of the disease on quality of life
Time frame: Month 9
Assessment of the impact of the disease on quality of life
Time frame: Month 15
Assessment of the impact of the disease on quality of life
Time frame: Month 15
Assessment of sarcopenia
Time frame: Month 15
Assessment of sarcopenia
Time frame: Month 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted motor activity in people with Breast Cancer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cyril FOA, MD (04 91 17 14 83 ext. 33, foacyril@club-internet.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of compliance (time frame: Month 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.