Clincosm LogoSign in Get a demo

SexoMBC2 Non Interventional Study

Sponsor
Institut de Cancérologie de Lorraine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05577156
Collaborator
(none)
80
Enrollment
1
Location
5.8
Anticipated Duration (Months)
13.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Self-questionnaires and semi-structured interview

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
80 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Sexual Quality of Life and Metastatic Breast Cancer
Actual Study Start Date :
Dec 5, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients

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

Outcome Measures

Primary Outcome Measures

  1. Assessment of sexual quality of life in women with HR+/HER2- metastatic breast cancer in first-line treatment [Day 0]

    Patients will fill the questionnaire : BISF-W (Brief Index of Sexual Function for Women)

Secondary Outcome Measures

  1. Assessment of overall quality of life in women with HR+/HER2- metastatic breast cancer in first-line treatment [Day 0]

    Patients will fill the QLQ-C30 questionnaire

  2. Assessment of overall quality of life in women with HR+/HER2- metastatic breast cancer in first-line treatment [Day 0]

    Patients will fill the QLQ+BR23 questionnaire

  3. Assessment of sexual and emotional intimacy [Day 0]

    semi-structured interview composed of 5 questions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Major woman

  • Patient with metastatic breast cancer, either initially or secondary metastatic breast cancer

  • RH+/HER2- tumor

  • Patient starting first line metastatic therapy or currently undergoing 1st line metastatic treatment

  • Patient diagnosed with metastatic breast cancer 6 months or more

  • WHO 1 or 2 patient

  • Postmenopausal or not

  • Patient able to understand the French language

Exclusion Criteria:

  • Patient WHO>2

  • Patient undergoing chemotherapy

  • HER2+ or triple negative tumor

  • Male

  • Patient diagnosed with breast cancer less than 6 months ago

  • Patient under guardianship, curatorship or safeguard of justice

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut de Cancerologie de Lorraine Vandœuvre-lès-Nancy France

Sponsors and Collaborators

  • Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: VINCENT MASSARD, Institut de Cancérologie de Lorraine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier:
NCT05577156
Other Study ID Numbers:
  • 2022-A01192-41
First Posted:
Oct 13, 2022
Last Update Posted:
Dec 23, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Dec 23, 2022