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EACE: Needs Assessment After Cancer in Patients Treated for Breast Cancer

Sponsor
Institut Jean-Godinot (Other)
Overall Status
Completed
CT.gov ID
NCT03902964
Collaborator
(none)
139
Enrollment
1
Location
2
Actual Duration (Months)
68.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

observational monocentric study

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    observational monocentric study

    Primary objective :

    Describe post-cancer supportive care needs, assessed by questionnaire in patients treated for breast cancer after completion of treatment and 2 years later.

    Secondary objective :

    • Correlation between needs after cancer and the fear of recidivism assessed by the scale of the inventory of fear.

    • Compare the need for supportive care between the end of treatment and 2 years after.

    • Assess needs after cancer according to the stage of the disease

    • Evaluate the needs after cancer according to the treatments received: surgery-radiotherapy versus surgery-chemotherapy-radiotherapy.

    • Assess needs after cancer according to age and socio-professional category.

    Schedule :

    The selected patients then received a letter including an information and non-objection note, the post-cancer needs questionnaire, the Fear Inventory severity subscale questionnaire, and the QLQ-C30 questionnaire. A delay of 1 month was chosen to return the questionnaire with a phone call after 15 days for an analysis of responses in February 2019.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    139 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Needs Assessment After Cancer in Patients Treated for Breast Cancer
    Actual Study Start Date :
    Dec 1, 2018
    Actual Primary Completion Date :
    Feb 1, 2019
    Actual Study Completion Date :
    Feb 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Post-cancer needs analysis [2 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    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.

    Exclusion Criteria:

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Jean Godinot Reims France 51100

    Sponsors and Collaborators

    • Institut Jean-Godinot

    Investigators

    • Principal Investigator: stephanie SERVAGI VERNAT, MD, Institut Jean-Godinot

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut Jean-Godinot
    ClinicalTrials.gov Identifier:
    NCT03902964
    Other Study ID Numbers:
    • 2018-A02191-54
    First Posted:
    Apr 4, 2019
    Last Update Posted:
    Apr 4, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Apr 4, 2019