Clinical trial NCT06517355: Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners
Official title: Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ORL Cancer
Keywords: ORL cancer
Onco-sexology care
Laryngectomy
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cancer (ORL) treated by laryngectomy.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: The primary endpoint is defined as the rate of patients meeting the acceptability criteria for onco-sexology management.
timeFrame: 14 months for each patient
Secondary outcomes:
measure: For the patients: Patients' sexual satisfaction will be assessed using the specific scale of the EORTC QLQSHQ-C22 questionnaire.
timeFrame: 14 months for each patient
measure: For the patients: Quality of life will be assessed using the EORTC QLQ-C30 questionnaire and the disease-specific QLQ-H&N43 questionnaire.
timeFrame: 14 months for each patient
measure: For the patients: The female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm).
timeFrame: 14 months for each patient
measure: For the patients: The ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction).
timeFrame: 14 months for each patient
measure: For the patients: The impact of (pharyngo)laryngectomy totale on the couple's relationship.
timeFrame: 14 months for each patient
measure: For the patients: Satisfaction or dissatisfaction with the onco-sexology consultation.
timeFrame: 14 months for each patient
measure: 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.
timeFrame: 14 months for each partner
measure: 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).
timeFrame: 14 months for each partner
measure: For the partner: Satisfaction or dissatisfaction with the onco-sexology consultation will be assessed using a Likert scale.
timeFrame: 14 months for each partner
Other outcomes:
Locations:
city: Toulouse
country: France
facility: IUCT-O
Study officials:
References: