Breast NeoplasmsREVISNCT02740491
Implementation of a "Remission" Consultation in the Management of Patients Treated for Localized Breast Cancer
An observational study of Breast Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Remission Consultation
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2016to 24 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Implementation of a "Remission" Consultation in the Management of Patients Treated for Localized Breast Cancer
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.
Read the detailed description
The secondary objectives of this study are:
- to describe changes in body image (Image Body Scale Version F) at 3, 6 and 12 months after a "remission" consultation.
- to describe changes in psychological distress (visual analog scale) at 3, 6 and 12 months after a "remission" consultation.
- to assess the time of resumption of work (date of last chemotherapy - date of the actual resumption of work) after a "remission" consultation.
- to evaluate the acceptance rate for the "remission" consultation.
- to describe the modes of the observed management, their distribution and the characteristics of the patients according to different monitoring arrangements.
- Conditions
- Breast Neoplasms
- Being tested
- Remission Consultation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Remission Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The EORTC QLQ-C30 questionnaire
Measured: Day 0
The EORTC QLQ-C30 questionnaire
Measured: Month 3
The EORTC QLQ-C30 questionnaire
Measured: Month 6
The EORTC QLQ-C30 questionnaire
Measured: Month 12
Secondary outcomes (12)
Body Image Scale
Measured: Day 0
Body Image Scale
Measured: Month 3
Body Image Scale
Measured: Month 6
Body Image Scale
Measured: Month 12
Psychological distress (visual analog scale)
Measured: Day 0
Psychological distress (visual analog scale)
Measured: Month 3
Psychological distress (visual analog scale)
Measured: Month 6
Psychological distress (visual analog scale)
Measured: Month 12
Work recovery time (date of last chemotherapy - date of the actual resumption of work)
Measured: Month 3
Work recovery time (date of last chemotherapy - date of the actual resumption of work)
Measured: Month 6
Work recovery time (date of last chemotherapy - date of the actual resumption of work)
Measured: Month 12
Acceptance of remission consultation (yes/no)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study start12 Sep 2016
- Primary completion4 Jun 2018
- Study completion24 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc Duwig, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740491
- Sponsor's protocol ID
- LOCAL/2016/LD-01
- Acronym
- REVIS
- Status last verified
- Jan 2026
- First submitted
- 7 Apr 2016
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 41024190
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implementation of a "Remission" Consultation in the Management of Patients Treated for Localized Breast Cancer
- ClinicalTrials.gov ID
- NCT02740491
- Acronym / sponsor ID
- REVIS / LOCAL/2016/LD-01
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 24 Oct 2019 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to describe changes in body image (Image Body Scale Version F) at 3, 6 and 12 months after a "remission" consultation.
- to describe changes in psychological distress (visual analog scale) at 3, 6 and 12 months after a "remission" consultation.
- to assess the time of resumption of work (date of last chemotherapy - date of the actual resumption of work) after a "remission" consultation.
- to evaluate the acceptance rate for the "remission" consultation.
- to describe the modes of the observed management, their distribution and the characteristics of the patients according to different monitoring arrangements.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Other: Remission ConsultationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remission ConsultationAt 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. | Other | The study population |
Primary outcome
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
The EORTC QLQ-C30 questionnaire
Time frame: Month 12
12 secondary outcomes
Body Image Scale
Time frame: Day 0
Body Image Scale
Time frame: Month 3
Body Image Scale
Time frame: Month 6
Body Image Scale
Time frame: Month 12
Psychological distress (visual analog scale)
Time frame: Day 0
Psychological distress (visual analog scale)
Time frame: Month 3
Psychological distress (visual analog scale)
Time frame: Month 6
Psychological distress (visual analog scale)
Time frame: Month 12
Work recovery time (date of last chemotherapy - date of the actual resumption of work)
Time frame: Month 3
Work recovery time (date of last chemotherapy - date of the actual resumption of work)
Time frame: Month 6
Work recovery time (date of last chemotherapy - date of the actual resumption of work)
Time frame: Month 12
Acceptance of remission consultation (yes/no)
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Results publication: PubMed 41024190Alonso 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.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Duwig, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The EORTC QLQ-C30 questionnaire (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02740491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.