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

May 20, 2025 updated by: Institut Claudius Regaud

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with cancer (ORL) treated by laryngectomy.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with cancer (ORL) treated by laryngectomy
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint is defined as the rate of patients meeting the acceptability criteria for onco-sexology management.
Time Frame: 14 months for each patient

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
For the patients: Patients' sexual satisfaction will be assessed using the specific scale of the EORTC QLQSHQ-C22 questionnaire.
Time Frame: 14 months for each patient
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
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.
Time Frame: 14 months for each patient
These are self-administered questionnaires validated in French.
14 months for each patient
For the patients: The female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm).
Time Frame: 14 months for each patient
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.
14 months for each patient
For the patients: The ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction).
Time Frame: 14 months for each patient
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).
14 months for each patient
For the patients: The impact of (pharyngo)laryngectomy totale on the couple's relationship.
Time Frame: 14 months for each patient
It will be assessed using a descriptive analysis (marital status before and after cancer treatment, stability, strengthening or deterioration of the couple's relationship).
14 months for each patient
For the patients: Satisfaction or dissatisfaction with the onco-sexology consultation.
Time Frame: 14 months for each patient
It will be assessed using a Likert scale. This type of scale was developed to measure attitudes and opinions (Rensis Likert 'A Technique for the Measurement of Attitudes', Archives of Psychology, vol.140, 1932, p. 1-55).
14 months for each patient
For the partner: - The rate of partners verifying the acceptability criteria for onco-sexology management is defined by the ratio of the number of partners verifying the acceptability criteria to the total number of partners included.
Time Frame: 14 months for each partner
The definition of acceptability is the same as for the primary endpoint.
14 months for each partner
For the partner: The impact of the (pharyngo)laryngectomy totale on the couple's relationship will be assessed using a descriptive analysis (stability, reinforcement or deterioration of the couple's life).
Time Frame: 14 months for each partner
14 months for each partner
For the partner: Satisfaction or dissatisfaction with the onco-sexology consultation will be assessed using a Likert scale.
Time Frame: 14 months for each partner
14 months for each partner

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24 VADS 01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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