Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners
ORL Cancer
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 45 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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 population
Patients with cancer (ORL) treated by laryngectomy.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
Patients with cancer (ORL) treated by laryngectomy
Not reported in this registry record.
Other: In this research, the procedure under study is represented:
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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.
Secondary measures
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
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.
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.
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).
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).
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).
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.
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
Not reported in this registry record.
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
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
IUCT-OToulouse, FranceRecruiting
Study team and timeline
- Lead sponsor
- Institut Claudius Regaud
- Study start
- Jul 30, 2024 Actual
- Primary completion
- Sep 30, 2030 Estimated
- Study completion
- Sep 30, 2030 Estimated
- First posted
- Jul 24, 2024 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026