Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06025604
Status:
RECRUITING
Last Update Posted:
2023-09-15
First Post:
2023-07-27
Brief Title:
ACTIVPROSEIN Professional Activity After Breast Cancer
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Psycho Social Factors Associated to Return to Work After Breast Cancer Care a Prognostic Study
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A01036-39 | OTHER | ID RCB | None |