NCT06025604

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
578

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

September 14, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2025

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

July 27, 2023

Last Update Submit

September 14, 2023

Conditions

Breast Cancer FemaleReturn to Work

Keywords

Observational studyPrognostic factorsQuestionary

Outcome Measures

Primary Outcomes (1)

  • 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

    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)

    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)

    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)

    30 minutes

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2023

First Posted

September 6, 2023

Study Start

September 14, 2023

Primary Completion

September 13, 2025

Study Completion

September 13, 2025

Last Updated

September 15, 2023

Record last verified: 2023-09

Locations

FR(1)