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Trial Title:
Impact of Onco-sexology Support on the Quality of Life of Patients Newly Diagnosed for Cancer
NCT ID:
NCT06332573
Condition:
Cancer
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:
Onco-sexology support
Description:
Initiation of onco-sexology support before the introduction of systemic oncology
treatment
Arm group label:
"Early intervention" group
Intervention type:
Other
Intervention name:
Onco-sexology support
Description:
Initiation of onco-sexology support after the introduction of systemic oncology treatment
(2-3 months after the start of treatment).
Arm group label:
"Late intervention" group
Summary:
Onco-sexology as a supportive care for patients treated for cancer is still rarely
discussed or even non-existent in 2022. However, it's recommended to integrate the
preservation of sexual health throughout the treatment and post-cancer process, given the
impact of cancer, treatments and the importance of intimate life for a majority of
patients.
Onco-sexology is one of the supportive care services validated by The French National
Cancer Institute (INCa). It is also an objective of the 2014-2019 cancer plan and the
2017-2030 national sexual health strategy plan.
Although sexuality is one of the fundamental needs of the human being, including in the
case of a chronic disease or cancer diagnosis, the lack of training of health
professionals to deal with intimate life, the difficulty to exchange on this subject
between caregivers and patients, the lack of financial support for onco-sexology
consultations, are all obstacles to the global management of oncology patients. However,
it's a request from patients to be able to discuss the subject in an intimate way with a
professional.
While onco-sexology is already recommended as supportive care, a study on the impact of
the delay in the management of sexual difficulties on quality of life could provide a
sufficient level of evidence to change the practices and the care pathway of the oncology
patient. Our objective is to study whether early management in onco-sexology has an
impact on quality of life compared to late management (ie onco-sexology consultation
before vs. after introduction of systemic oncological treatment).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Aged ≥ 18 years
- Newly cancer diagnosis, including palliative care
- Having given free and informed written consent
Exclusion Criteria:
- Pregnant or breastfeeding woman
- Persons deprived of their liberty by a judicial or administrative decision.
- Persons who are subject to a legal protection measure or who are unable to express
their consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Européen Marseille
Address:
City:
Marseille
Country:
France
Contact:
Last name:
Myriam BENNANI
Phone:
0413428351
Email:
m.bennani@hopital-europeen.fr
Start date:
November 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Hôpital Européen Marseille
Agency class:
Other
Source:
Hôpital Européen Marseille
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06332573
