Clinical trial · Observational
Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners
NCT06517355CI-TRIAL-00114892ABSENSrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ORL Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| In this research, the procedure under study is represented: | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with cancer (ORL) treated by laryngectomy
- interventionNames
- Other: In this research, the procedure under study is represented:
Primary outcomes (1)
- measure
- The primary endpoint is defined as the rate of patients meeting the acceptability criteria for onco-sexology management.
- timeFrame
- 14 months for each patient
- description
- This rate corresponds to the ratio of the number of patients meeting the acceptability criteria to the total number of patients included. Acceptability is defined when the following two criteria are validated: * Completion of onco-sexology consultations 2 and 3 (at 3 and 12 months after cancer treatment) * Patient satisfaction ≥ 3 on a numerical scale from 1 to 5.
Secondary outcomes (9)
- measure
- For the patients: Patients' sexual satisfaction will be assessed using the specific scale of the EORTC QLQSHQ-C22 questionnaire.
- timeFrame
- 14 months for each patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: For patients: 1. Patient to be treated for ORL cancer by total (pharyngo)laryngectomy 2. Patient WHO 0-1-2 3. Age greater than or equal to 18 years 4. Patient who has not objected to participation in the study. For partners (if applicable) : 1. Age greater than or equal to 18 years 2. Subject who has not objected to participation in the study. Exclusion Criteria: For patients: 1. Patient with another co-existing malignant disease at the time of inclusion. 2. 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. 3. 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).
References
Publications (0)
Data not yet available
No reference posted for this study.