Implementation of a "Remission" Consultation in the Management of Patients Treated for Localized Breast Cancer

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT02740491
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The main objective of this study is to describe the evolution in quality of life (QLQ-C30) for patients receiving breast cancer care at 3, 6 and 12 months after a "remission" consultation.

Detailed Description

The secondary objectives of this study are:

A. to describe changes in body image (Image Body Scale Version F) at 3, 6 and 12 months after a "remission" consultation.

B. to describe changes in psychological distress (visual analog scale) at 3, 6 and 12 months after a "remission" consultation.

C. to assess the time of resumption of work (date of last chemotherapy - date of the actual resumption of work) after a "remission" consultation.

D. to evaluate the acceptance rate for the "remission" consultation.

E. to describe the modes of the observed management, their distribution and the characteristics of the patients according to different monitoring arrangements.

Study Timeline

• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-15
• Study Start: 2016-09-12
• Primary Completion: 2018-06-04
• Study Completion: 2019-10-24
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• The patient is receiving care for localized breast cancer and finished her adjuvant treatment (chemotherapy, radiotherapy)
• The patient has completed his/her adjuvant therapy in the last 6 months (chemotherapy, radiotherapy).

Exclusion Criteria

• The patient is participating in another study
• The patient is under judicial protection
• It is impossible to correctly inform the patient
• The patient has a metastatic form of the disease at diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The EORTC QLQ-C30 questionnaire	Month 12

Secondary Outcome Measures

Name	Time	Method
Psychological distress (visual analog scale)	Month 12
Work recovery time (date of last chemotherapy - date of the actual resumption of work)	Month 12
Body Image Scale	Month 12
Acceptance of remission consultation (yes/no)	Day 0

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France