MedTrace Logo

SexoMBC2 Non Interventional Study

NCT05577156 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2023-07-28

No results posted yet for this study

Summary

The study is composed of three paper self-questionnaires to be filled in by the patients included at distance (\> 6 months) from their diagnosis of metastatic breast cancer, in order to limit the impact of the announcement on the filling out the questionnaires.

After verification of the eligibility criteria, the medical oncologist will present the study to patients coming to the ICL for a follow-up consultation as part of their regular care. The patients will meet with a clinical research nurse so that she can explain the again and answer any questions they may have. She will also give the patients the questionnaires questionnaires and will give a presentation of the questions asked. After this meeting, the patients will be given sufficient time to reflect on, which may extend until their next visit to the ICL, in order to express, if they wish, their opposition to participating in the study. If she agrees to participate, the patient can then complete the questionnaires as well as the complementary questionnaire and place them in a closed envelope to be given to the clinical research nurse. The completion of the questionnaires will be completely anonymous. The data of those who object to the use of their data will be deleted from the database.

After the completion of the questionnaires, and in order to allow a benefit for the patient, a semi-directive interview in the form of a teleconsultation with a psycho-oncologist and sexologist will be offered. The interviews are not mandatory.

The time to fill in the self-questionnaires is estimated at 30 minutes and the semi-directive interview can last up to one hour. Finally, at the end of the study, as part of her subsequent care, each patient participating in the study will have the possibility to renew a teleconsultation with the psycho-oncologist and sexologist if she feels the need. As the subject of the study may generate personal questions and lead to a request for psychological and/or sexological care.

Conditions

Interventions

BEHAVIORAL

Self-questionnaires and semi-structured interview

Patients will fill these questionnaires : BISF-W, QLQ-C30, QLQ-BR23 and if they agree answer to a semi-structured interview composed of 5 questions

Sponsors & Collaborators

  • Institut de Cancérologie de Lorraine

    lead OTHER

Principal Investigators

  • VINCENT MASSARD · Institut de Cancérologie de Lorraine

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2023-05-17
Completion
2023-05-17

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05577156 on ClinicalTrials.gov