Cancer and Sexual Health : Early Information and Sexual Satisfaction of Couples in Oncology
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change from baseline in Quality Life (QLQ C30) due to a specific information about the sexuality on the sexual satisfaction of the couples, assessed
研究概览
简要总结
In a perspective of improvement of the global care of the patients, investigators wish to estimate, within the oncology department of Paris Saint Joseph Hospital, the impact of a clear, written and oral information, on the sexual satisfaction of the couples during treatments.
Further to this study, the project will be to train and to sensitize the medical staff, or still to develop new activities to meet the needs better of patients and of partners.
详细描述
To answer the objective, investigators set up a longitudinal study of a maximum duration of 18 months to recruit a minimum of 60 couples distributed in two groups:
The inclusion in the study will be made in two phases:
- The couples of the non-interventional group (NI) will be recruited at first to avoid the possibility to of sharing information between patients on their care. Indeed, it is about a comparative study and it is necessary that the couples of the NI group do not know about information proposed to the group I, at the risk of cancelling the effect of the information.
- The couples of the interventional group (I) will so be recruited during the last phase of the study of the NI group, that is approximately 6 months after the beginning of the study.
The choice of the minimal size of participants' sample is stretched out by the necessity of a minimum number of 30 participants by group to make relevant statistical analyses.
Once the information were given to the patients and to the partners, according to the group in which they are included, the participants will perform individually same sets of validated questionnaires at three different point times:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients and partners declaring itself in couple or having a shared private life;
- •Patients diagnosed by an initial cancer, the prognosis for survival of which at the time of the diagnosis is upper to one year;
- •Patients and partners of more than 18 years old, mastering the French language, and in measure to give their informed consent
排除标准
- •Patients having been diagnosed and/or treated for another cancer;
- •Patients and partners having a psychiatric disorder (confusional syndrome, psychotic disorders, disrupted reality perception)
- •Patients and partners protected by the law, according to articles L.1121-5 to L.1121-8 of the Public health code.
研究组 & 干预措施
INFORMED
Interventional Group (I): Couples enrolled during the diagnosis will receive written information as usual about the disease and in addition they benefit special oral interviews and written information about experiences of their sexuality during the illness.The document used for the interventional group is "Sexuality and Cancer" and will be given to couples. (intervention: Oral information and interviews about sexuality and self experience during the disease). Qualitative analysis will be provided by a psychologist
干预措施: Oral information and interviews (Behavioral)
ORDINARY USE
Non-interventional Group (NI): Couples enrolled during the diagnosis will only receive written information about their experience of disease . The document used fot the non interventional group is "Live during and after cancer"and will be given to couples. Qualitative analysis will be provided by a psychologist
结局指标
主要结局
Change from baseline in Quality Life (QLQ C30) due to a specific information about the sexuality on the sexual satisfaction of the couples, assessed
时间窗: Participants will be followed during 6 months
3 times points: Randomization (Day 1), 2 months and 6 months post-inclusion
次要结局
- Change from baseline in Sexual Satisfaction Score (ESS) due to a specific information about the sexuality on the sexual satisfaction of the couples, assessed(Participants will be followed during 6 months)