ACTIVPROSEIN : Professional Activity After Breast Cancer

NCT ID: NCT06025604

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 578 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-14
• Study Completion Date: 2025-09-13

Brief 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.

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.

Conditions

Breast Cancer Female; Return to Work

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Grenoble Alpes

Grenoble, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Emmanuelle GA JACQUET

Role: primary

ejacquet1@chu-grenoble.fr

+33476765451

Anne Stoeckle

Role: backup

AStoeckle@chu-grenoble.fr

Other Identifiers

2023-A01036-39

Identifier Type: OTHER

Identifier Source: secondary_id

38RC23.0151

Identifier Type: -

Identifier Source: org_study_id