Trial Title:
Assessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request
NCT ID:
NCT06415266
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
quality of sexual life
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Quality of life questionnaire (QLQ)
Description:
Quality of life questionnaire : EORTC QLQ-C30, EORTC QLQ-Breast cancer module (BR) 23,
EORTC SHQ-C22 et HADS at inclusion, visit 1 (6 months +/-1 month before the inclusion),
visit 2 (12 months +/-1 month before the inclusion), visit 3 (18 months +/-1 month before
the inclusion) and visit 4 (24 months +/-1 month before the inclusion).
Arm group label:
Patients receiving oncoSexology supportive care on proactive
Arm group label:
Patients receiving oncoSexology supportive care on request
Intervention type:
Other
Intervention name:
Satisfaction survey
Description:
The satisfaction score will be collected using a visual analog scale from 0 to 10 and the
satisfaction questionnaire will also be completed at visit 4 (24 months +/- 1 month
before the inclusion).
Arm group label:
Patients receiving oncoSexology supportive care on proactive
Arm group label:
Patients receiving oncoSexology supportive care on request
Intervention type:
Other
Intervention name:
Assessment of patient needs in the field of oncosexology
Description:
Assessment of patient needs in the field of oncosexology during a face-to-face or virtual
interview at inclusion and every 6 months for 2 years. If a need is identified, an
oncosexology consultation will be organised. Following this, a personalised care plan may
be proposed.
Arm group label:
Patients receiving oncoSexology supportive care on proactive
Summary:
The study compares the quality of sexual life of breast cancer patients under two types
of oncoSexology supportive care : personalized supportive care versus on-request. The aim
is to improve the quality of sexual life of these patients.
Detailed description:
Breast cancer and its treatment are responsible for symptoms that can persist over time
and affect quality of life. Given the improved prognosis for breast cancer, more and more
patients are faced with the specific problems of the post-cancer period, and caring for
them has become a major health issue. Sexual health is a crucial component of well-being
and overall quality of life.
The study compares the quality of sexual life of breast cancer patients under two types
of oncoSexology supportive care : personalized supportive care versus on-request.
For that, quality of life questionnaires will be completed by patients at inclusion and
every 6 months for 2 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Woman or man at least 18 years old
- Diagnosis of infiltrating breast cancer regardless of the biological characteristics
of the tumor
- Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum
of 3 months ago with the exception of post-neoadjuvant treatments (chemotherapy,
poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment,
...) which must have been started less than 3 months previously
- Patient with sufficient command of the French language to be able to answer the
questionnaires
- Patient having given informed, written and express consent.
- Affiliation to the French Social Security System
- Willingness and ability to comply with scheduled visits, treatment plan and other
study procedures
Exclusion Criteria:
- Patient already taken cared of in oncosexology. The following are not criteria for
non-inclusion (a previous single consultation without treatment, use of local
vaginal treatments)
- Metastatic disease
- Patient under guardianship, curatorship or safeguard of justice
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut de Cancérologie de l'Ouest
Address:
City:
Saint-Herblain
Zip:
44805
Country:
France
Contact:
Last name:
Aliette DEZELLUS, Dr
Phone:
02 40 67 99 00
Phone ext:
+33
Email:
aliette.dezellus@ico.unicancer.fr
Facility:
Name:
Institut de Cancérologie de Lorraine
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54519
Country:
France
Contact:
Last name:
Claire CHARRA-BRUNAUD, Dr
Phone:
03 83 59 86 10
Phone ext:
+33
Email:
c.brunaud@nancy.unicancer.fr
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Contact:
Last name:
Philippe TOUSSAINT, Dr
Phone:
04 78 78 28 40
Phone ext:
+33
Email:
philippe.toussaint@lyon.unicancer.fr
Facility:
Name:
ICM Val d'Aurelle
Address:
City:
Montpellier
Zip:
34298
Country:
France
Contact:
Last name:
Véronique D'HONDT, Dr
Phone:
04 67 61 25 07
Phone ext:
+33
Email:
Veronique.Dhondt@icm.unicancer.fr
Contact backup:
Last name:
Angélique BOBRIE, Dr
Phone:
04 67 61 85 76
Phone ext:
+33
Email:
Angelique.Bobrie@icm.unicancer.fr
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Zip:
06189
Country:
France
Contact:
Last name:
Anne CREISSON, Dr
Phone:
04 92 03 16 43
Phone ext:
+33
Email:
anne.creisson@nice.unicancer.fr
Facility:
Name:
CHU de Nîmes
Address:
City:
Nîmes
Zip:
30029
Country:
France
Contact:
Last name:
Frédéric FITENI, Dr
Phone:
04 66 68 33 01
Phone ext:
+33
Email:
frederic.fiteni@chu-nimes.fr
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Contact:
Last name:
Silène DELORME
Email:
silene.delorme@curie.fr
Facility:
Name:
IUCT - Oncopole
Address:
City:
Toulouse
Zip:
31100
Country:
France
Contact:
Last name:
Eva JOUVE, Dr
Phone:
05 31 15 60 16
Phone ext:
+33
Email:
jouve.eva@iuct-oncopole.fr
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Contact:
Last name:
Marion AUPOMEROL, Dr
Email:
Marion.AUPOMEROL@gustaveroussy.fr
Start date:
May 2024
Completion date:
May 2028
Lead sponsor:
Agency:
Institut du Cancer de Montpellier - Val d'Aurelle
Agency class:
Other
Source:
Institut du Cancer de Montpellier - Val d'Aurelle
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06415266
