Needs Assessment After Cancer in Patients Treated for Breast Cancer

Quality of Life Clinical Trial

— EACE  

Official title:

Needs Assessment After Cancer in Patients Treated for Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902964
• Other study ID #: 2018-A02191-54
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: April 2019
• Source: Institut Jean-Godinot
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

observational monocentric study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Fear Cancer
• Quality of Life

Locations

Country	Name	City	State
France	Institut Jean Godinot	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Institut Jean-Godinot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-cancer needs analysis	Post-cancer needs analysis based on the "post-cancer needs assessment" questionnaire for patients in both cohorts	2 years