Impact of Onco-sexology Support on the Quality of Life of Patients Newly Diagnosed for Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Onco-sexology support, Onco-sexology support.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Other Onco-sexology support
Initiation of onco-sexology support before the introduction of systemic oncology treatment - Other Onco-sexology support
Initiation of onco-sexology support after the introduction of systemic oncology treatment (2-3 months after the start of treatment).
Primary outcome measures
- 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 outcome measures (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 [Time frame: 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) [Time frame: 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) [Time frame: 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 ". [Time frame: 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". [Time frame: 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 [Time frame: 6 and 12 months after the end of onco-sexology support]
- Rate of patients expressing sexual difficulties during the consultation of announcement [Time frame: 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Hôpital Européen Marseille — Marseille
Identifiers
NCT: NCT06332573 · 24-06