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Completed

NCT Number: NCT02740491

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remission Consultation

Other

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.

Primary outcomes

  1. The EORTC QLQ-C30 questionnaire

    Time frame: Day 0

  2. The EORTC QLQ-C30 questionnaire

    Time frame: Month 3

  3. The EORTC QLQ-C30 questionnaire

    Time frame: Month 6

  4. The EORTC QLQ-C30 questionnaire

    Time frame: Month 12

Secondary outcomes

  1. Body Image Scale

    Time frame: Day 0

  2. Body Image Scale

    Time frame: Month 3

  3. Body Image Scale

    Time frame: Month 6

  4. Body Image Scale

    Time frame: Month 12

  5. Psychological distress (visual analog scale)

    Time frame: Day 0

  6. Psychological distress (visual analog scale)

    Time frame: Month 3

  7. Psychological distress (visual analog scale)

    Time frame: Month 6

  8. Psychological distress (visual analog scale)

    Time frame: Month 12

  9. Work recovery time (date of last chemotherapy - date of the actual resumption of work)

    Time frame: Month 3

  10. Work recovery time (date of last chemotherapy - date of the actual resumption of work)

    Time frame: Month 6

  11. Work recovery time (date of last chemotherapy - date of the actual resumption of work)

    Time frame: Month 12

  12. Acceptance of remission consultation (yes/no)

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: REVIS

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Apr 15, 2016
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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