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

Breast Neoplasms Clinical Trial

— REVIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02740491
• Other study ID #: LOCAL/2016/LD-01
• Status: Completed
• Start date: September 12, 2016
• Est. completion date: October 24, 2019

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 24, 2019
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• Remission Consultation
At the end of adjuvant treatment (adjuvant chemotherapy and / or radiotherapy), the patient is seen by a referent oncologist and included in the study. A "Remission" consultation with a psychotherapist is then proposed and its purpose explained to the patient. The patient agrees or refuses take advantage of the "Remission" consultation; in case of refusal, the reasons are documented and further information is provided, thus giving the opportunity for the patient to benefit from further psychological counseling if desired. If approval is given, the patient will be scheduled for the "Remission" consultation (duration 1 hour) . The latter includes a first phase evaluating the mental state of the patient, and then a proposal of individualized care if necessary and according to several methods, depending on the choice of the patient.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The EORTC QLQ-C30 questionnaire		Day 0
Primary	The EORTC QLQ-C30 questionnaire		Month 3
Primary	The EORTC QLQ-C30 questionnaire		Month 6
Primary	The EORTC QLQ-C30 questionnaire		Month 12
Secondary	Body Image Scale		Day 0
Secondary	Body Image Scale		Month 3
Secondary	Body Image Scale		Month 6
Secondary	Body Image Scale		Month 12
Secondary	Psychological distress (visual analog scale)		Day 0
Secondary	Psychological distress (visual analog scale)		Month 3
Secondary	Psychological distress (visual analog scale)		Month 6
Secondary	Psychological distress (visual analog scale)		Month 12
Secondary	Work recovery time (date of last chemotherapy - date of the actual resumption of work)		Month 3
Secondary	Work recovery time (date of last chemotherapy - date of the actual resumption of work)		Month 6
Secondary	Work recovery time (date of last chemotherapy - date of the actual resumption of work)		Month 12
Secondary	Acceptance of remission consultation (yes/no)		Day 0