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

Recruiting

• Conditions: ORL Cancer

• Registration Number: NCT06517355
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-23
• Study First Posted: 2024-07-24
• Study Start: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is defined as the rate of patients meeting the acceptability criteria for onco-sexology management.	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 Outcome Measures

Name	Time	Method
For the patients: Quality of life will be assessed using the EORTC QLQ-C30 questionnaire and the disease-specific QLQ-H&N43 questionnaire.	14 months for each patient	These are self-administered questionnaires validated in French.
For the patients: The impact of (pharyngo)laryngectomy totale on the couple's relationship.	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 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.	14 months for each partner	The definition of acceptability is the same as for the primary endpoint.
For the patients: Patients' sexual satisfaction will be assessed using the specific scale of the EORTC QLQSHQ-C22 questionnaire.	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 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).	14 months for each partner
For the patients: The female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm).	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).	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: Satisfaction or dissatisfaction with the onco-sexology consultation.	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: Satisfaction or dissatisfaction with the onco-sexology consultation will be assessed using a Likert scale.	14 months for each partner

Trial Locations

Locations (1)

IUCT-O; 🇫🇷 Toulouse, France