Health Related Quality of Life and Multidimensional Evaluations of a Cohort of Prostate Cancer Subjects Aged ≥ 60 Years Initiating Gonadotropin-Releasing Hormone (GNRH) Agonist Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 831
- 试验地点
- 1
- 主要终点
- Quality of Life (QOL) as evaluated by Quality of Life Questionnaire-Elderly 14 items (QLQ-ELD-14)
研究概览
简要总结
The objective of the study is to compare the evolution over 6 months of Health-Related Quality of Life (HRQOL) among different age groups in subjects with prostate cancer treated with GnRH agonist therapy.
详细描述
Relevant data collected as part of routine medical care will be captured on an electronic Case Report Form (eCRF). Investigator-subject questionnaires and subject self-questionnaires answers will be collected in a paper booklet. This study is non-interventional, thus if some assessments, are not routinely performed by the investigator, he/she will not complete the corresponding sections in the eCRF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject presenting with histologically confirmed prostate cancer
- •Subject of 60 years and older
- •Subject eligible to start GnRH agonist therapy, either as monotherapy or adjuvant therapy, and for whom one of these treatments was selected voluntarily by the investigator, prior to the start of the study
- •Subject giving his written consent to participate in the study
- •Subject able to complete questionnaires
排除标准
- •Subject simultaneously participating in a clinical trial
- •Subject who previously received a hormonal therapy during the last 6 months before inclusion
研究组 & 干预措施
Prostate cancer subjects 60-<70 years
干预措施: Data collection (Other)
Prostate cancer subjects 70-<75 years
干预措施: Data collection (Other)
Prostate cancer subjects ≥ 75 years
干预措施: Data collection (Other)
结局指标
主要结局
Quality of Life (QOL) as evaluated by Quality of Life Questionnaire-Elderly 14 items (QLQ-ELD-14)
时间窗: Change from baseline at 6 months
Evolution overall and in subgroups of age (\[60-\<70\], \[70- \<75\] and ≥ 75 years).
次要结局
- Sexual function scores as evaluated by 3 questions on sexual domain of the Urolife Benign Prostatic Hyperplasia-Quality Of Life 9 (BPH-QoL 9) questionnaire(Baseline and 6 months)
- Sexual function VAS score(Baseline and 6 months)
- HRQOL Visual Analog Scale (VAS) score(Baseline and 6 months)
- Health status scores as evaluated by G8 questionnaire(Baseline and 6 months)
- Overall condition VAS score(Baseline and 6 months)
- Urinary function scores as evaluated by QOL question of the International Prostate Symptom Score (IPSS)(Baseline and 6 months)
- Urinary function score VAS(Baseline and 6 months)
- Cognitive status scores as evaluated by Mini Mental State (MMS)(Baseline and 6 months)
- Memory VAS score(Baseline and 6 months)
- Mood scores as evaluated by mini Geriatric Depression Scale (GDS) questionnaire(Baseline and 6 months)
- Mood VAS score(Baseline and 6 months)
- Motricity scores as evaluated by G8 questionnaire specific domain (3rd item)(Baseline and 6 months)
- VAS motricity score(Baseline and 6 months)
- Autonomy question(Baseline and 6 months)
- Autonomy VAS score(Baseline and 6 months)