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Clinical Trials/NCT02740491
NCT02740491
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes1 site in 1 country50 target enrollmentSeptember 12, 2016

Overview

Phase
Not Applicable
Intervention
Remission Consultation
Conditions
Breast Neoplasms
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
50
Locations
1
Primary Endpoint
The EORTC QLQ-C30 questionnaire
Status
Completed
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 12, 2016
End Date
October 24, 2019
Last Updated
3 months ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

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

Arms & Interventions

The 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.

Intervention: Remission Consultation

Outcomes

Primary Outcomes

The EORTC QLQ-C30 questionnaire

Time Frame: Month 12

The EORTC QLQ-C30 questionnaire

Time Frame: Day 0

The EORTC QLQ-C30 questionnaire

Time Frame: Month 3

The EORTC QLQ-C30 questionnaire

Time Frame: Month 6

Secondary Outcomes

  • 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)
  • Body Image Scale(Day 0)
  • Body Image Scale(Month 3)
  • Body Image Scale(Month 6)
  • Psychological distress (visual analog scale)(Day 0)
  • Psychological distress (visual analog scale)(Month 3)
  • Psychological distress (visual analog scale)(Month 6)
  • Work recovery time (date of last chemotherapy - date of the actual resumption of work)(Month 3)
  • Work recovery time (date of last chemotherapy - date of the actual resumption of work)(Month 6)

Study Sites (1)

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