Impact of the Perception of Cohesion Within a Relationship (Dyadic Adjustment) on the Quality of Life of Patients With Prostate Cancer With Gonadotropin-releasing Hormone (GnRH) Agonist Therapy Initiated by the Urologist in the Routine Practice. Evaluation by the Patient and the Partner.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change in quality of life of the patient.
研究概览
简要总结
The general hypothesis put forward in this study is that the degree of cohesion (agreement) in the relationship, or dyadic adjustment affects a patient's quality of life and clinical course during the first few critical months following diagnosis and the introduction of treatment. The level of cohesion in the relationship is certainly not the only parameter associated with changes in the quality of life. Other factors must also be investigated such as level of education, circumstances surrounding the diagnosis (new diagnosis or relapse), management (single therapy or adjuvant therapy), the level of physical activity, the patient's age and the presence of functional disorders, etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient presenting with histologically confirmed prostate cancer.
- •Patient eligible to start GnRH agonist therapy, either as monotherapy or adjuvant therapy, and for whom one of these treatments was selected voluntarily by the urologist, prior to the start of the study.
- •Patient currently living with the same partner for at least 6 months.
- •Patient and partner capable of reading, understanding and returning an evaluation self-questionnaire 6 months after the initial consultation.
- •Patient giving its written consent to participate to the study.
排除标准
- •The subject is participating in another clinical trial.
- •Patient who has received a GnRH agonist therapy during the last 2 years.
研究组 & 干预措施
Prostate cancer patients
干预措施: Gonadotropin-releasing Hormone (GnRH) agonist therapy (Drug)
结局指标
主要结局
Change in quality of life of the patient.
时间窗: Baseline and 6 months
Assessment of the dyadic adjustment and its impact on the quality of life of the patient through self-questionnaire by the patient and the partner
次要结局
- Proportion of couples with a consistency or inconsistency level of dyadic adjustment(6 months)
- Assessment of representations of illness(Baseline)
- Investigation of factors associated with patient's perception of dyadic adjustment on changes quality of life(Baseline and 6 months)
- Correlations between quality of life specific to prostate cancer, general quality of life and dyadic adjustment.(6 months)