Impact of Onco-sexology Support on the Quality of Life of Patients Newly Diagnosed for Cancer

NCT ID: NCT06332573

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-22
• Study Completion Date: 2028-01-22

Brief 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).

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

"Early intervention" group

Group Type: EXPERIMENTAL

Onco-sexology support

Intervention Type: OTHER

Initiation of onco-sexology support before the introduction of systemic oncology treatment

"Late intervention" group

Group Type: OTHER

Onco-sexology support

Intervention Type: OTHER

Initiation of onco-sexology support after the introduction of systemic oncology treatment (2-3 months after the start of treatment).

Interventions

Onco-sexology support

Initiation of onco-sexology support before the introduction of systemic oncology treatment

Intervention Type: OTHER

Onco-sexology support

Initiation of onco-sexology support after the introduction of systemic oncology treatment (2-3 months after the start of treatment).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Européen Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Européen Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Myriam BENNANI

Role: primary

m.bennani@hopital-europeen.fr

0413428351

Other Identifiers

24-06

Identifier Type: -

Identifier Source: org_study_id