NCT06517355招募中不适用
Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The primary endpoint is defined as the rate of patients meeting the acceptability criteria for onco-sexology management.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Patients with cancer (ORL) treated by laryngectomy
干预措施: In this research, the procedure under study is represented: (Other)
结局指标
主要结局
The primary endpoint is defined as the rate of patients meeting the acceptability criteria for onco-sexology management.
时间窗: 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.
次要结局
- 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)
- For the patients: The impact of (pharyngo)laryngectomy totale on the couple's relationship.(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.(14 months for each partner)
- For the patients: Patients' sexual satisfaction will be assessed using the specific scale of the EORTC QLQSHQ-C22 questionnaire.(14 months for each patient)
- 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)
- For the patients: The ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction).(14 months for each patient)
- For the patients: Satisfaction or dissatisfaction with the onco-sexology consultation.(14 months for each patient)
- For the partner: Satisfaction or dissatisfaction with the onco-sexology consultation will be assessed using a Likert scale.(14 months for each partner)
研究者
研究点 (1)
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