Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Needs Assessment After Cancer in Patients Treated for Breast Cancer (EACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902964
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Jean-Godinot

Brief Summary:
observational monocentric study

Condition or disease
Breast Neoplasm Female Quality of Life Fear Cancer

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.


Layout table for study information
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 : December 1, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
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



Primary Outcome Measures :
  1. Post-cancer needs analysis [ Time Frame: 2 years ]
    Post-cancer needs analysis based on the "post-cancer needs assessment" questionnaire for patients in both cohorts



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902964


Locations
Layout table for location information
France
Institut Jean Godinot
Reims, France, 51100
Sponsors and Collaborators
Institut Jean-Godinot
Investigators
Layout table for investigator information
Principal Investigator: stephanie SERVAGI VERNAT, MD Institut Jean-Godinot

Layout table for additonal information
Responsible Party: Institut Jean-Godinot
ClinicalTrials.gov Identifier: NCT03902964     History of Changes
Other Study ID Numbers: 2018-A02191-54
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases