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

I

Institut Claudius Regaud

Status

Enrolling

Conditions

ORL Cancer

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06517355
24 VADS 01

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

45 participants in 1 patient group

Patients with cancer (ORL) treated by laryngectomy
Treatment:
Other: In this research, the procedure under study is represented:

Trial contacts and locations

1

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Central trial contact

Julienne VIDAL

Data sourced from clinicaltrials.gov

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