Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners
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: In this research, the procedure under study is represented:.
- Who it may be relevant to
- Registry conditions: ORL 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
Single-centre prospective pilot study designed to demonstrate the acceptability of onco-sexology management for laryngectomy patients and their partners in order to improve their perception of their intimate life. This is a non-interventional study (category 3 Loi Jardé), which will not result in any change in patient management. All procedures will be carried out in accordance with standard practice. Patients will be followed for 14 months.
Interventions
- Other In this research, the procedure under study is represented:
* On the one hand, by carrying out sexology consultations which consist of individual interviews with a qualified sexologist nurse. * Secondly, questionnaires to assess quality of life and sexual function, to be completed by patients during standard follow-up consultations; and a questionnaire on satisfaction with sexological follow-up, to be completed by patients and their partners (if applicable) during the last standard follow-up consultation.
Primary outcome measures
- The primary endpoint is defined as the rate of patients meeting the acceptability criteria for onco-sexology management. [Time frame: 14 months for each patient]
Secondary outcome measures (9)
- For the patients: Patients' sexual satisfaction will be assessed using the specific scale of the EORTC QLQSHQ-C22 questionnaire. [Time frame: 14 months for each patient]
- For the patients: Quality of life will be assessed using the EORTC QLQ-C30 questionnaire and the disease-specific QLQ-H&N43 questionnaire. [Time frame: 14 months for each patient]
- For the patients: The female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm). [Time frame: 14 months for each patient]
- For the patients: The ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction). [Time frame: 14 months for each patient]
- For the patients: The impact of (pharyngo)laryngectomy totale on the couple's relationship. [Time frame: 14 months for each patient]
- For the patients: Satisfaction or dissatisfaction with the onco-sexology consultation. [Time frame: 14 months for each patient]
- For the partner: - The rate of partners verifying the acceptability criteria for onco-sexology management is defined by the ratio of the number of partners verifying the acceptability criteria to the total number of partners included. [Time frame: 14 months for each partner]
- For the partner: The impact of the (pharyngo)laryngectomy totale on the couple's relationship will be assessed using a descriptive analysis (stability, reinforcement or deterioration of the couple's life). [Time frame: 14 months for each partner]
- For the partner: Satisfaction or dissatisfaction with the onco-sexology consultation will be assessed using a Likert scale. [Time frame: 14 months for each partner]
Eligibility criteria
Inclusion criteria
For patients:
- Patient to be treated for ORL cancer by total (pharyngo)laryngectomy
- Patient WHO 0-1-2
- Age greater than or equal to 18 years
- Patient who has not objected to participation in the study.
For partners (if applicable) :
- Age greater than or equal to 18 years
- Subject who has not objected to participation in the study.
Exclusion criteria
For patients:
- Patient with another co-existing malignant disease at the time of inclusion.
- Any psychological, familial, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures foreseen in the study protocol.
- Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).
For partners (if applicable):
1\. Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 1 center
- IUCT-O — Toulouse
Identifiers
NCT: NCT06517355 · 24 VADS 01