Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners
ConditionORL Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Claudius Regaud
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
Patients with cancer (ORL) treated by laryngectomy.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
In this research, the procedure under study is represented:
Other intervention* 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.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Patients with cancer (ORL) treated by laryngectomy1 intervention
Trial outcomes
Primary outcomes
1
The primary endpoint is defined as the rate of patients meeting the acceptability criteria for onco-sexology management.
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.
Time frame
14 months for each patientSecondary outcomes
1
For the patients: Patients' sexual satisfaction will be assessed using the specific scale of the EORTC QLQSHQ-C22 questionnaire.
The score, which ranges from 0 to 100, is determined according to the algorithm published by the EORTC, based on answers to 8 questions. This is a self-administered questionnaire validated in French
Time frame
14 months for each patient2
For the patients: Quality of life will be assessed using the EORTC QLQ-C30 questionnaire and the disease-specific QLQ-H&N43 questionnaire.
These are self-administered questionnaires validated in French.
Time frame
14 months for each patient3
For the patients: The female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm).
The FSFI (Female Sexual Function Index) is a self-administered questionnaire validated in French. It comprises 19 items studying 6 dimensions of female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm) which make up an overall score of between 2 and 36.
Time frame
14 months for each patient4
For the patients: The ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction).
The MSHQ (Male Sexual Health Questionnaire) is a self-questionnaire validated in French which assesses the ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction).
Time frame
14 months for each patientSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov