Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners

NCT ID: NCT06517355

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2028-03-31

Brief Summary

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

ORL Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with cancer (ORL) treated by laryngectomy

In this research, the procedure under study is represented:

Intervention Type: OTHER

• 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IUCT-O

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Julienne VIDAL

Role: CONTACT

vidal.julienne@iuct-oncopole.fr

05 31 15 51 36

Facility Contacts

Josiane MENARD

Role: primary

menard.josiane@iuct-oncopole.fr

05 31 15 51 36

Other Identifiers

24 VADS 01

Identifier Type: -

Identifier Source: org_study_id