Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Quality of life as assessed by the QLQ-30 questionnaire
研究概览
简要总结
RATIONALE: Gathering information from patients who received treatment for metastatic cancer while participating in a phase II or phase III randomized clinical trial and from patients receiving standard treatment off-trial may help doctors learn more about the psychological and emotional results of being in a clinical trial.
PURPOSE: This clinical trial is comparing the psychological and emotional impact of participating in a randomized clinical trial with the impact of standard treatment in patients with metastatic cancer.
详细描述
OBJECTIVES:
Primary
- To compare the psychological and emotional consequences in patients who underwent first-line antitumor treatment (chemotherapy or targeted therapy) for metastatic disease while participating in a phase II or III randomized clinical trial vs patients who underwent standard first-line treatment off-trial.
Secondary
- To measure and compare the temporal variation of psychological and emotional consequences during and after completion of or stopping of treatment.
- To measure and compare the degree of knowledge of the implications of participating in a clinical study vs the benefits of standard off-trial treatment and evaluate the impact on psychological and emotional experience.
- To evaluate the relationship between the use of adjustment strategies and emotional regulation and psychological and emotional experiences in both of these situations.
研究设计
- 研究类型
- Observational
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Quality of life as assessed by the QLQ-30 questionnaire
Symptoms of anxiety and depression as assessed by the HADS questionnaire
Adjustment strategies and emotional regulation as assessed by the WCC and ERQ questionnaires
次要结局
未报告次要终点