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Implementation of a "Remission" Consultation in the Management of Patients Treated for Localized Breast Cancer (REVIS)

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ClinicalTrials.gov Identifier: NCT02740491
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment
Breast Neoplasms Other: 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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Implementation of a "Remission" Consultation in the Management of Patients Treated for Localized Breast Cancer
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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

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 Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740491


Contacts
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Contact: Luc Duwig, MD +33.(0)4.66.68.33.01 luc.duwig@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
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France
CHRU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Luc Duwig, MD         
Sub-Investigator: Luc Farcy, MD         
Sub-Investigator: Nadine Houédé, MD, PhD         
Sub-Investigator: Sylvie Van Hulst, MD         
Sub-Investigator: Miruna Timar-David, MD         
Sub-Investigator: Florence Lai Tiong, MD         
Sub-Investigator: Catherine Ferrer, MD         
Sub-Investigator: Françoise Bons, MD         
Sub-Investigator: Marie-Pierre Farcy Jaquet, MD         
Sub-Investigator: Charles Debrigode, MD         
Sub-Investigator: Philippe Lang, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Luc Duwig, MD Centre Hospitalier Universitaire de Nîmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02740491     History of Changes
Other Study ID Numbers: LOCAL/2016/LD-01
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases