ORL CancerABSENSNCT06517355
Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners
An observational study of ORL Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ORL Cancer
- What is being tested?
- In this research, the procedure under study is represented:
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2024to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cancer (ORL) treated by laryngectomy.
Who may be able to join
- 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.
Who cannot join
- For patients:
- Patient with another co-existing malignant disease at the time of inclusion.
- 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):
- 1. Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
IUCT-O
Toulouse
Josiane MENARD, 05 31 15 51 36, menard.josiane@iuct-oncopole.fr
About this study
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
- Being tested
- In this research, the procedure under study is represented:
- Keywords
- ORL cancer, Onco-sexology care, Laryngectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cancer (ORL) treated by laryngectomy | Not described Receives: Other: In this research, the procedure under study is represented: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
Measured: 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.
These are self-administered questionnaires validated in French.
Measured: 14 months for each patient
For the patients: The female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm).
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.
Measured: 14 months for each patient
For the patients: The ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction).
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).
Measured: 14 months for each patient
For the patients: The impact of (pharyngo)laryngectomy totale on the couple's relationship.
It will be assessed using a descriptive analysis (marital status before and after cancer treatment, stability, strengthening or deterioration of the couple's relationship).
Measured: 14 months for each patient
For the patients: Satisfaction or dissatisfaction with the onco-sexology consultation.
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).
Measured: 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.
The definition of acceptability is the same as for the primary endpoint.
Measured: 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).
Measured: 14 months for each partner
For the partner: Satisfaction or dissatisfaction with the onco-sexology consultation will be assessed using a Likert scale.
Measured: 14 months for each partner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start30 Jul 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ORL CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517355
- Sponsor's protocol ID
- 24 VADS 01
- Acronym
- ABSENS
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners
- ClinicalTrials.gov ID
- NCT06517355
- Acronym / sponsor ID
- ABSENS / 24 VADS 01
- Conditions
- ORL Cancer
- Keywords
- ORL cancer, Onco-sexology care, Laryngectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cancer (ORL) treated by laryngectomy | – | Other: In this research, the procedure under study is represented: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer (ORL) treated by laryngectomy.
Key inclusion criteria (8 listed)
- 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.
- Age greater than or equal to 18 years
Key exclusion criteria (6 listed)
- Patient with another co-existing malignant disease at the time of inclusion.
- 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).
- 1. Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients with cancer (ORL) treated by laryngectomy |
Primary outcome
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.
9 secondary outcomes
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
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
For the patients: The female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm).
Time frame: 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
For the patients: The impact of (pharyngo)laryngectomy totale on the couple's relationship.
Time frame: 14 months for each patient
For the patients: Satisfaction or dissatisfaction with the onco-sexology consultation.
Time frame: 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ORL Cancer, run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julienne VIDAL (05 31 15 51 36, vidal.julienne@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.