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

NCT06517355 | Recruiting

• 1 other identifier: 24 VADS 01
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

ORL cancer; Onco-sexology care; Laryngectomy

Outcome Measures

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.

  14 months for each patient

Secondary Outcomes (9)

• For the patients: Patients' sexual satisfaction will be assessed using the specific scale of the EORTC QLQSHQ-C22 questionnaire.

  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.

  14 months for each patient

• For the patients: The female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm).

  14 months for each patient

• For the patients: The ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction).

  14 months for each patient

• For the patients: The impact of (pharyngo)laryngectomy totale on the couple's relationship.

  14 months for each patient

Study Arms (1)

Patients with cancer (ORL) treated by laryngectomy

Other: In this research, the procedure under study is represented:

Interventions

In this research, the procedure under study is represented: 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.

Patients with cancer (ORL) treated by laryngectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cancer (ORL) treated by laryngectomy.

You may qualify if:

• 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.

You may not qualify if:

• For patients:
• 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):
• \. Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

IUCT-O

Toulouse, France

RECRUITING

Central Study Contacts

Julienne VIDAL

CONTACT

05 31 15 51 36; vidal.julienne@iuct-oncopole.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

FR (1)