NEOPSYCO STUDY: Trajectories of Anxiety and Depression in Cancer Patients, Risk and Predictive Factors and Supportive Care; Prognostic Awareness and Shared Decision Making.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 540
- 试验地点
- 18
- 主要终点
- Anxiety and depression symptoms
研究概览
简要总结
To examine the trajectories of anxiety and depression symptoms over the course of oncological disease, and to assess potential predictors-sociodemographic (age, sex, marital status, employment status), clinical (tumor location, stage, treatment type, general health), psychological (coping strategies, quality of life, cognitive difficulties, fear of recurrence), and physical activity-and their association with support needs and utilization of psychosocial services.
详细描述
The study population consists of consecutive oncology patients recruited across multiple centers, with data collection occurring at baseline (diagnosis or treatment initiation) and at 3-month and 6-month follow-up time points.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of solid cancer (non-hematologic) at any stage.
- •Adult age (>18 years).
- •Candidate for perioperative systemic antineoplastic treatment or for advanced disease.
- •Willingness to participate in the study and sign the informed consent form, as appropriate, before initiating any study-specific procedures, in accordance with good clinical practice requirements and local regulations.
排除标准
- •Presence of a pre-existing psychiatric or neurodegenerative disorder that impairs the patient's ability to participate in the study.
- •Presence of reading and writing difficulties that prevent the patient from completing the assessments.
- •Receipt of oncological treatment in the past 2 years for another cancer.
结局指标
主要结局
Anxiety and depression symptoms
时间窗: At the time of diagnosis or treatment initiation. Follow-up at 3 months: To assess the early evolution of symptoms. Follow-up at 6 months: To analyze the medium-term evolution.
The primary outcome of our study is psychological distress, specifically anxiety and depression symptoms, which will be measured using the Brief Symptom Inventory-18 (BSI-18). BSI-18 provides a single outcome measure for distress. The scoring ranges are as follows: 0-66 (low risk of depression and/or anxiety), 67-71 (intermediate risk), and \>71 (clinically significant distress).
次要结局
未报告次要终点