NCT03902964

Brief Summary

observational monocentric study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

April 3, 2019

Last Update Submit

April 3, 2019

Conditions

Breast Neoplasm FemaleQuality of LifeFear Cancer

Outcome Measures

Primary Outcomes (1)

  • Post-cancer needs analysis

    Post-cancer needs analysis based on the "post-cancer needs assessment" questionnaire for patients in both cohorts

    2 years

Study Arms (2)

women treated for breast cancer in 2017 (cohort A)

all patients who completed breast cancer treatment between January 1 and May 31, 2017. Withdrawal of men, metastatic patients from the outset, patients with a history of breast cancer or any other location, selection of 20 patients with breast cancer in situ at random

women treated for breast cancer in 2015 (cohorte B)

all patients who completed breast cancer treatment between January 1 and 31 May 2015. Withdrawal of men, metastatic patients from the outset, patients with a history of breast cancer or any other location, selection of 20 patients with breast cancer in situ at random

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who completed breast cancer treatment between January 1 and May 31, 2017, and between January 1 and 31 May 2015. Withdrawal of men, metastatic patients from the outset, patients with a history of breast cancer or any other location, selection of 20 patients with breast cancer in situ at random in each of the 2 cohorts.

You may qualify if:

  • Women who have been treated for breast cancer and whose treatment ended in 2017 (cohort A) and in 2015 (cohort B), aged between 18 and 80 years, and who declared their non-opposition free and enlightened.

You may not qualify if:

  • Patients who have been treated for recurrence or 2nd cancer, metastases from the outset, male, refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Jean Godinot

Reims, 51100, France

Location

MeSH Terms

Conditions

Pathophobia

Study Officials

  • stephanie SERVAGI VERNAT, MD

    Institut Jean-Godinot

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 4, 2019

Study Start

December 1, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)