Breast CancerAPACAMNCT05523063
Effect of Physical Activity in Patients With Breast Cancer.
An observational study of Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Every year in France, there are approximately 58,000 new cases of breast cancer, which is the leading cancer in women according to the National Cancer Institute. Among the various tools in the fight against cancer, it is now proven that physical activity improves the prognosis of cancers, particularly breast cancer. 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?
- Quality of life questionnaire
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2022to Feb 2023
- Phase
- Observational
- 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
Study population: The trial population concerns all adult patients with breast cancer followed at the Croix-Rousse hospital, who have been under care for less than 3 months at CAMI or who are going to be treated at CAMI.
Who may be able to join
- Adult patients aged 18 years or older at inclusion,
- With breast cancer (diagnosis of breast cancer proven by anatomopathological evidence; all stages of the disease accepted), including recurrences,
- Followed at the Croix-Rousse Hospital and managed by the CAMI for less than 3 months,
- Provision of an informed information and collection of non-opposition.
Who cannot join
- Patients who do not speak French,
- Persons of legal age who are the subject of a legal protection measure,
- Persons deprived of liberty by a judicial or administrative decision, persons under psychiatric care,
- Pregnant or parturient women.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gynécologie-Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, 69004
About this study
Official title: Effects on Quality of Life of Adapted Physical Activity Supervised by CAMI for Breast Cancer Patients.
Every year in France, there are approximately 58,000 new cases of breast cancer, which is the leading cancer in women according to the National Cancer Institute.
Among the various tools in the fight against cancer, it is now proven that physical activity improves the prognosis of cancers, particularly breast cancer.
Read more
Indeed, APA (Adapted Physical Activity) reduces morbidity and mortality, the risk of recurrence and improves quality of life. It is one of the tools of the Ten-Year Cancer Control Strategy 2021-2030 of the anti-cancer plan.
However, it seems to be insufficiently proposed and prescribed in France at present.
CAMI (Cancer Arts Martiaux et Information) is a non-profit association comprising health professionals specifically trained to support cancer patients through APA. It works in collaboration with the Hospices Civils de Lyon and in particular the Gynecology Department of the CHU (University Hospital Center) of Croix Rousse.
According to the World Health Organization (WHO), quality of life is "an individual's perception of his or her place in life, in the context of the culture and value system in which he or she lives, in relation to his or her goals, expectations, norms and concerns. It is a very broad concept influenced in a complex way by the subject's physical health, psychological state, level of independence, social relationships as well as their relationship to the essential elements of their environment."
Quality of life is thus synonymous with well-being, perceived health and life satisfaction. The quality of a person's life is based both on the objective elements of his or her life (physical health, living environment and material and/or contextual conditions) and on his or her experience, which can be defined as the subjective quality of life.
Thus, quality of life is considered to be a multidimensional concept that is structured around four dimensions, the first of which encompasses the physical state (autonomy, physical abilities), the second the somatic sensations that often translate into the expression of pain, the consequences of trauma related to the disease or treatment.
With the increase in the incidence of breast cancer and the improvement in its prognosis, the number of breast cancer survivors has increased significantly. Quality of life has become an important outcome measure in clinical breast cancer surveys and survival studies, in addition to survival.
The investigators' main objective is to study the effects of APA managed by CAMI in routine practice, on the quality of life of breast cancer patients.
They also want to analyze how, by whom, and which patients are referred to CAMI to improve their care and describe the program offered by CAMI.
The aim of this research is therefore to establish an axis of work and improvement for the Gynecology Department of the Croix Rousse Hospital in order to better identify the patients for whom APA would be most beneficial, to better refer them to CAMI and to study in real practice the effects of APA on these patients.
- Conditions
- Breast Cancer
- Being tested
- Quality of life questionnaire
- Keywords
- Adapted physical activity, Quality of life, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnaireOther
The quality of life questionnaire will be performed in routine practice by the CAMI during the initial assessment.
The 3-month visit is part of the routine patient visit to CAMI. During this visit, the quality of life questionnaire will be completed a second time by the patients, through a phone call given by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients followed at CAMI | The trial population concerns all adult patients with breast cancer followed at the Croix-Rousse hospital, who have been under care for less than 3 months or who are going to be treated at the CAMI. Receives: Other: Quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of life questionnaire score
Difference between the quality of life questionnaire score calculated at baseline (first visit at CAMI) and after 3 months of follow-up by CAMI. The minimum and maximum values of the Quality of life questionnaire are respectively 0 (bad quality of life) and 100 (good quality of life).
Measured: Change from Baseline Score of the Quality of life at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Why it stopped: Study classified as out of scope by the Ethics Committee (not a project involving human person).
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion CORTET, MD, Principal investigator, Service de Gynécologie-Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523063
- Sponsor's protocol ID
- 69HCL22_0613
- Acronym
- APACAM
- Status last verified
- Oct 2022
- First submitted
- 29 Aug 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Quality of Life of Adapted Physical Activity Supervised by CAMI for Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT05523063
- Acronym / sponsor ID
- APACAM / 69HCL22_0613
- Conditions
- Breast Cancer
- Keywords
- Adapted physical activity, Quality of life, Breast cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study classified as out of scope by the Ethics Committee (not a project involving human person).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 31 Aug 2022 (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.
Every year in France, there are approximately 58,000 new cases of breast cancer, which is the leading cancer in women according to the National Cancer Institute.
Among the various tools in the fight against cancer, it is now proven that physical activity improves the prognosis of cancers, particularly breast cancer.
Indeed, APA (Adapted Physical Activity) reduces morbidity and mortality, the risk of recurrence and improves quality of life. It is one of the tools of the Ten-Year Cancer Control Strategy 2021-2030 of the anti-cancer plan.
However, it seems to be insufficiently proposed and prescribed in France at present.
CAMI (Cancer Arts Martiaux et Information) is a non-profit association comprising health professionals specifically trained to support cancer patients through APA. It works in collaboration with the Hospices Civils de Lyon and in particular the Gynecology Department of the CHU (University Hospital Center) of Croix Rousse.
According to the World Health Organization (WHO), quality of life is "an individual's perception of his or her place in life, in the context of the culture and value system in which he or she lives, in relation to his or her goals, expectations, norms and concerns. It is a very broad concept influenced in a complex way by the subject's physical health, psychological state, level of independence, social relationships as well as their relationship to the essential elements of their environment."
Quality of life is thus synonymous with well-being, perceived health and life satisfaction. The quality of a person's life is based both on the objective elements of his or her life (physical health, living environment and material and/or contextual conditions) and on his or her experience, which can be defined as the subjective quality of life.
Thus, quality of life is considered to be a multidimensional concept that is structured around four dimensions, the first of which encompasses the physical state (autonomy, physical abilities), the second the somatic sensations that often translate into the expression of pain, the consequences of trauma related to the disease or treatment.
With the increase in the incidence of breast cancer and the improvement in its prognosis, the number of breast cancer survivors has increased significantly. Quality of life has become an important outcome measure in clinical breast cancer surveys and survival studies, in addition to survival.
The investigators' main objective is to study the effects of APA managed by CAMI in routine practice, on the quality of life of breast cancer patients.
They also want to analyze how, by whom, and which patients are referred to CAMI to improve their care and describe the program offered by CAMI.
The aim of this research is therefore to establish an axis of work and improvement for the Gynecology Department of the Croix Rousse Hospital in order to better identify the patients for whom APA would be most beneficial, to better refer them to CAMI and to study in real practice the effects of APA on these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients followed at CAMI | – | Other: Quality of life questionnaireThe trial population concerns all adult patients with breast cancer followed at the Croix-Rousse hospital, who have been under care for less than 3 months or who are going to be treated at the CAMI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The trial population concerns all adult patients with breast cancer followed at the Croix-Rousse hospital, who have been under care for less than 3 months at CAMI or who are going to be treated at CAMI.
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older at inclusion,
- With breast cancer (diagnosis of breast cancer proven by anatomopathological evidence; all stages of the disease accepted), including recurrences,
- Followed at the Croix-Rousse Hospital and managed by the CAMI for less than 3 months,
- Provision of an informed information and collection of non-opposition.
Key exclusion criteria (4 listed)
- Patients who do not speak French,
- Persons of legal age who are the subject of a legal protection measure,
- Persons deprived of liberty by a judicial or administrative decision, persons under psychiatric care,
- Pregnant or parturient women.
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 |
|---|---|---|
| Quality of life questionnaireThe quality of life questionnaire will be performed in routine practice by the CAMI during the initial assessment. The 3-month visit is part of the routine patient visit to CAMI. During this visit, the quality of life questionnaire will be completed a second time by the patients, through a phone call given by the investigator. | Other | Breast cancer patients followed at CAMI |
Primary outcome
Change in Quality of life questionnaire score
Time frame: Change from Baseline Score of the Quality of life at 3 months
Difference between the quality of life questionnaire score calculated at baseline (first visit at CAMI) and after 3 months of follow-up by CAMI. The minimum and maximum values of the Quality of life questionnaire are respectively 0 (bad quality of life) and 100 (good quality of life).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
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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.
Marion CORTET, MD principal investigator
Service de Gynécologie-Obstétrique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hospices Civils de Lyon 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 24 Oct 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life questionnaire score (time frame: Change from Baseline Score of the Quality of life at 3 months). 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 24 Oct 2022.