Clinical trial NCT02740491: Implementation of a "Remission" Consultation in the Management of Patients Treated for Localized Breast Cancer
Official title: Evaluation of the Implementation of a "Remission" Consultation in the Management of Patients Treated for Localized Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult patients diagnosed with localized breast cancer who have completed adjuvant treatment (chemotherapy, radiotherapy) and who are cared for in the Medical Oncology department of the Nîmes University Hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The EORTC QLQ-C30 questionnaire
timeFrame: Day 0
measure: The EORTC QLQ-C30 questionnaire
timeFrame: Month 3
measure: The EORTC QLQ-C30 questionnaire
timeFrame: Month 6
measure: The EORTC QLQ-C30 questionnaire
timeFrame: Month 12
Secondary outcomes:
measure: Body Image Scale
timeFrame: Day 0
measure: Body Image Scale
timeFrame: Month 3
measure: Body Image Scale
timeFrame: Month 6
measure: Body Image Scale
timeFrame: Month 12
measure: Psychological distress (visual analog scale)
timeFrame: Day 0
measure: Psychological distress (visual analog scale)
timeFrame: Month 3
measure: Psychological distress (visual analog scale)
timeFrame: Month 6
measure: Psychological distress (visual analog scale)
timeFrame: Month 12
measure: Work recovery time (date of last chemotherapy - date of the actual resumption of work)
timeFrame: Month 3
measure: Work recovery time (date of last chemotherapy - date of the actual resumption of work)
timeFrame: Month 6
measure: Work recovery time (date of last chemotherapy - date of the actual resumption of work)
timeFrame: Month 12
measure: Acceptance of remission consultation (yes/no)
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Luc Duwig, MD
role: PRINCIPAL_INVESTIGATOR
References: