Breast Cancer FemaleNCT06025604
ACTIVPROSEIN : Professional Activity After Breast Cancer
An observational study of Breast Cancer Female and Return to Work, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Breast cancer is, in term of incidence, the first cancer among women in France and worldwide. This incidence is increasing, particularly among young women during their professional activity. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer Female, Return to Work
- How many people
- 578 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2023to 13 Sep 2025
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Women between 18 and 60 years old, care in Grenoble University Hospital between 2015 and 2019 for a localized breast cancer, working at the time of diagnosis.
Who may be able to join
- Patient between 18 and 60 years old
- Histologically proven localized breast cancer, of any subtype
- Cared in Grenoble University Hospital between 2015 and 2019
- Working at the time of diagnosis
Who cannot join
- Retired at the end of adjuvant therapy
- Deprived of liberty, under juridical protection, not able to give consent
- Psychiatric conditions or addictive behavior interfering with questionary filling
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble, 38043
Emmanuelle GA JACQUET, +33476765451, ejacquet1@chu-grenoble.fr
Anne Stoeckle, AStoeckle@chu-grenoble.fr
About this study
Official title: Psycho Social Factors Associated to Return to Work After Breast Cancer Care : a Prognostic Study
Breast cancer is, in term of incidence, the first cancer among women in France and worldwide. This incidence is increasing, particularly among young women during their professional activity.
Those observations raise de question of return to work of those patients, and, broadly, of the post cancer life and former activities recovery.
Read more
The objective of the study is to identify any factor influencing time from diagnosis to return to work (type of treatment, side effects, residual symptoms, medical staff support, occupational physician monitoring, individual or group supportive therapy, adapted physical activity, alternative therapeutics ..), and the main modalities of return to work (part or full time, professional redeployment).
To identify those factors, barriers or supports, would enable the implementation of concrete actions and programs, promoting return to work, and to a free disease life for those patients.
The main objective is to identify psycho social factors involved in the time from diagnosis to return to any modality of work, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included) Secondary objectives are to identify psycho social factors involved in the time from diagnosis to return to work, part time, full time, and redeployment, respectively, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
Read the detailed description
Patients being took care in Grenoble University Hospital, including Voiron site, from 2015 to 2019, for a localized breast cancer, will be identified be Cristal Link software.
A questionary, including every studied variables and potential confounding factors, will be sent, by post or by e mail, to the patients. An information notice and a non opposition formulary will be joined to the questionary.
Patients will be contacted by a paramedical member of the Women Cancer Center of the University Hospital, in order to explain them the objective of the study, and the modality of personal data management.
The questionary will be returned either by mail, or directly brought back to the Hospital along a medical appointment.
Data collection will focus on return to work delay, return to work modality (part or full time, redeployment), studied variables and potential confounding factors (demographic : marital status, number of dependent children, incomes / related to occupational activity : night work, job responsibility, occupational physician follow up / treatment consequences : OMS status, anxiety, depression, lymphoedema, articular pain, neuropathic pain / Support measures : physical activities, psychological support, alternative therapeutics, familial support, medical staff support).
Medical data (tumour features : histology, extent, treatment : surgery, chemiotherapy, targeted therapy, hormonotherapy, radiotherapy) will be collected using informatic files.
Subjective variables will be evaluated using standardized questionary (Anxiety : Stait Trait Anxiety Inventory / Depression : Hamilton Depression Scale / Cognition : FACT cog questionary / Support : Multidimensional Scale of Support).
Data process will be done in the Clinical Investigation Center of Grenoble University Hospital.
- Conditions
- Breast Cancer Female, Return to Work
- Keywords
- Observational study, Prognostic factors, Questionary
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the impact of psycho social factors on delay of return to any modality of work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
Assessment of delay of a any occupational activity recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables
Measured: 30 minutes
Secondary outcomes (3)
To identify the impact of psycho social factors on delay of return to full time work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
Assessment of delay of full time work recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables
Measured: 30 minutes
To identify the impact of psycho social factors on delay of return to part time work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
Assessment of delay of part time work recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables
Measured: 30 minutes
To identify the impact of psycho social factors on delay of return to occupational reclassification, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
Assessment of delay of occupational reclassification, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start14 Sep 2023
- Primary completion13 Sep 2025 (estimated)
- Study completion13 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 578 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025604
- Sponsor's protocol ID
- 38RC23.0151
- Other IDs
- 2023-A01036-39
- Status last verified
- Sep 2023
- First submitted
- 27 Jul 2023
- Last updated
- 15 Sep 2023
- 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 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psycho Social Factors Associated to Return to Work After Breast Cancer Care : a Prognostic Study
- ClinicalTrials.gov ID
- NCT06025604
- Acronym / sponsor ID
- 38RC23.0151
- Conditions
- Breast Cancer Female, Return to Work
- Keywords
- Observational study, Prognostic factors, Questionary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 578 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 13 Sep 2025 (estimated)
- Study completion
- 13 Sep 2025 (estimated)
- First posted
- 6 Sep 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.
Breast cancer is, in term of incidence, the first cancer among women in France and worldwide. This incidence is increasing, particularly among young women during their professional activity.
Those observations raise de question of return to work of those patients, and, broadly, of the post cancer life and former activities recovery.
The objective of the study is to identify any factor influencing time from diagnosis to return to work (type of treatment, side effects, residual symptoms, medical staff support, occupational physician monitoring, individual or group supportive therapy, adapted physical activity, alternative therapeutics ..), and the main modalities of return to work (part or full time, professional redeployment).
To identify those factors, barriers or supports, would enable the implementation of concrete actions and programs, promoting return to work, and to a free disease life for those patients.
The main objective is to identify psycho social factors involved in the time from diagnosis to return to any modality of work, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included) Secondary objectives are to identify psycho social factors involved in the time from diagnosis to return to work, part time, full time, and redeployment, respectively, until 24 month after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
Detailed description
Patients being took care in Grenoble University Hospital, including Voiron site, from 2015 to 2019, for a localized breast cancer, will be identified be Cristal Link software.
A questionary, including every studied variables and potential confounding factors, will be sent, by post or by e mail, to the patients. An information notice and a non opposition formulary will be joined to the questionary.
Patients will be contacted by a paramedical member of the Women Cancer Center of the University Hospital, in order to explain them the objective of the study, and the modality of personal data management.
The questionary will be returned either by mail, or directly brought back to the Hospital along a medical appointment.
Data collection will focus on return to work delay, return to work modality (part or full time, redeployment), studied variables and potential confounding factors (demographic : marital status, number of dependent children, incomes / related to occupational activity : night work, job responsibility, occupational physician follow up / treatment consequences : OMS status, anxiety, depression, lymphoedema, articular pain, neuropathic pain / Support measures : physical activities, psychological support, alternative therapeutics, familial support, medical staff support).
Medical data (tumour features : histology, extent, treatment : surgery, chemiotherapy, targeted therapy, hormonotherapy, radiotherapy) will be collected using informatic files.
Subjective variables will be evaluated using standardized questionary (Anxiety : Stait Trait Anxiety Inventory / Depression : Hamilton Depression Scale / Cognition : FACT cog questionary / Support : Multidimensional Scale of Support).
Data process will be done in the Clinical Investigation Center of Grenoble University Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women between 18 and 60 years old, care in Grenoble University Hospital between 2015 and 2019 for a localized breast cancer, working at the time of diagnosis.
Key inclusion criteria (4 listed)
- Patient between 18 and 60 years old
- Histologically proven localized breast cancer, of any subtype
- Cared in Grenoble University Hospital between 2015 and 2019
- Working at the time of diagnosis
Key exclusion criteria (3 listed)
- Retired at the end of adjuvant therapy
- Deprived of liberty, under juridical protection, not able to give consent
- Psychiatric conditions or addictive behavior interfering with questionary filling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify the impact of psycho social factors on delay of return to any modality of work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
Time frame: 30 minutes
Assessment of delay of a any occupational activity recovery, from the diagnosis and until 24 months after treatment, and of any influenced factors by self administrated questionnaire, included standardized questionnaire for subjective variables
3 secondary outcomes
To identify the impact of psycho social factors on delay of return to full time work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
Time frame: 30 minutes
To identify the impact of psycho social factors on delay of return to part time work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
Time frame: 30 minutes
To identify the impact of psycho social factors on delay of return to occupational reclassification, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included)
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
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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?
An observational study of Breast Cancer Female and Return to Work, run by University Hospital, Grenoble 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 3 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 15 Sep 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the impact of psycho social factors on delay of return to any modality of work, until 24 months after localized breast cancer care, in Grenoble University Hospital (Michalon and Voiron included) (time frame: 30 minutes). 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 15 Sep 2023; AzTrials last refreshed its copy on 31 Oct 2026.