NCT02740491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 12, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2019

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

April 7, 2016

Last Update Submit

January 21, 2026

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (4)

  • The EORTC QLQ-C30 questionnaire

    Day 0

  • The EORTC QLQ-C30 questionnaire

    Month 3

  • The EORTC QLQ-C30 questionnaire

    Month 6

  • The EORTC QLQ-C30 questionnaire

    Month 12

Secondary Outcomes (12)

  • Body Image Scale

    Day 0

  • Body Image Scale

    Month 3

  • Body Image Scale

    Month 6

  • Body Image Scale

    Month 12

  • Psychological distress (visual analog scale)

    Day 0

  • +7 more secondary outcomes

Study Arms (1)

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.

Other: Remission Consultation

Interventions

Remission ConsultationOTHER

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.

The study population

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

  • Alonso S, Kabani S, Fabbro-Peray P, Houede N, Duwig L. A feasibility study of scheduling a remission consultation in the management of patients treated for localized breast cancer. BMC Psychol. 2025 Sep 29;13(1):1087. doi: 10.1186/s40359-025-03393-6.

    PMID: 41024190RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Luc Duwig, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 15, 2016

Study Start

September 12, 2016

Primary Completion

June 4, 2018

Study Completion

October 24, 2019

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

FR(1)