Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06025604 |
Other study ID # |
38RC23.0151 |
Secondary ID |
2023-A01036-39 |
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 14, 2023 |
Est. completion date |
September 13, 2025 |
Study information
Verified date |
September 2023 |
Source |
University Hospital, Grenoble |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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.
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)
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.