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

Cancer Clinical Trial

— SEXOCARE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06332573
• Other study ID #: 24-06
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Hôpital Européen Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: December 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Onco-sexology support
Initiation of onco-sexology support before the introduction of systemic oncology treatment
• Onco-sexology support
Initiation of onco-sexology support after the introduction of systemic oncology treatment (2-3 months after the start of treatment).

Locations

Country	Name	City	State
France	Hôpital Européen Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with improved quality of life as measured by the 36-Item Short Form Survey (SF-36) at the end of onco-sexology support		4 months
Secondary	Evaluation of the quality of life of patients at 6 and 12 months after the end of onco-sexology support through the 36-Item Short Form Survey (SF-36) questionnaire		6 and 12 months after the end of onco-sexology support
Secondary	Evaluation of the quality of sexual life at the end of the onco-sexology support in both groups through specific questionnaires (The sexual quality of life-female and men)		4 months
Secondary	Evaluation of the quality of sexual life at 6 and 12 months after the end of the onco-sexology support through specific questionnaires (The sexual quality of life-female and men)		6 and 12 months after the end of onco-sexology support
Secondary	Evaluation of the body image, at the end of the onco-sexology support through the "Body Image Scale ".		4 months
Secondary	Evaluation of the body image, of the patient at 6 and 12 months after the last consultation with the onco-sexologist through the "Body Image Scale".		6 and 12 months after the last consultation with the onco-sexologist
Secondary	Evaluation of the satisfaction of the patient at the end of the care in onco-sexology care		6 and 12 months after the end of onco-sexology support
Secondary	Rate of patients expressing sexual difficulties during the consultation of announcement		24 months