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

NCT06332573 | Recruiting

• 1 other identifier: 24-06
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

• 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

• Evaluation of the body image, at the end of the onco-sexology support through the "Body Image Scale ".

  4 months

• 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

Study Arms (2)

"Early intervention" group

EXPERIMENTAL

Other: Onco-sexology support

"Late intervention" group

OTHER

Other: Onco-sexology support

Interventions

Onco-sexology support OTHER

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

"Early intervention" group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years
• Newly cancer diagnosis, including palliative care
• Having given free and informed written consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (1)

Hôpital Européen Marseille

Marseille, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: March 27, 2024
• Study Start: April 22, 2025
• Primary Completion (Estimated): August 22, 2027
• Study Completion (Estimated): January 22, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)