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

Обзор

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).

Вмешательства

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

Первичные конечные точки

• 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 [Срок оценки: 4 months]

Вторичные конечные точки (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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 ". [Срок оценки: 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". [Срок оценки: 6 and 12 months after the last consultation with the onco-sexologist]
• Evaluation of the satisfaction of the patient at the end of the care in onco-sexology care [Срок оценки: 6 and 12 months after the end of onco-sexology support]
• Rate of patients expressing sexual difficulties during the consultation of announcement [Срок оценки: 24 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Hôpital Européen Marseille — Marseille

Идентификаторы

NCT: NCT06332573 · 24-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗