Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners
NCT Number: NCT06517355
Acronym: ABSENS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: ORL Cancer
Interventions: OTHER: In this research, the procedure under study is represented:
Sponsor: Institut Claudius Regaud
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2026-09
Locations: IUCT-O, Toulouse, France

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.

Primary Outcome Measures: 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., 14 months for each patient
Secondary Outcome Measures: 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, 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., 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., 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)., 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)., 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)., 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., 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)., 14 months for each partner|For the partner: Satisfaction or dissatisfaction with the onco-sexology consultation will be assessed using a Likert scale., 14 months for each partner