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NCT Number: NCT06332573

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

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Européen Marseille

Marseille, France

Location status: Recruiting

Location contact

Myriam BENNANI

CONTACT

[email protected]

0413428351

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Onco-sexology support

Other

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

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

    Time frame: 4 months

Secondary outcomes

  1. 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

    Time frame: 6 and 12 months after the end of onco-sexology support

  2. 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)

    Time frame: 4 months

  3. 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)

    Time frame: 6 and 12 months after the end of onco-sexology support

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

    Time frame: 4 months

  5. 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".

    Time frame: 6 and 12 months after the last consultation with the onco-sexologist

  6. Evaluation of the satisfaction of the patient at the end of the care in onco-sexology care

    Time frame: 6 and 12 months after the end of onco-sexology support

  7. Rate of patients expressing sexual difficulties during the consultation of announcement

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Hôpital Européen Marseille

Other

Registry information

Acronym: SEXOCARE

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 27, 2024
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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