Retrospective and Prospective Observational Study on Cardiological and Oncological Psychosomatics
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Cumulative incidence of new relevant medical events
研究概览
简要总结
Psychological processes play a complex role in the pathophysiology of many diseases. However, the body and emotional perception of patients and the relationship between dreams and disease still need to be investigated.
The investigators planned an observational and controlled research aimed at assessing some previously unaddressed baseline psychological characteristics and their changes at 1 and 5 years after a short-term psychotherapy in carefully characterised patients with heart or oncologic diseases .
The patients that will be enrolled are:
- 50 patients ≤ 75 year old with acute myocardial infarction;
- 30 patients ≤ 75 year old with Tako-Tsubo syndrome;
- 50 women ≤ 75 year old, recently operated on breast cancer:
- 90 control subjects of the same age and gender of the enrolled patients, without relevant pathologies during the last 10 years. Relevant pathologies are defined as those that required a hospitalisation or a long-lasting medical therapy.
At the enrolment all the subjects will undergo a complete medical evaluation, and the following psychometric tests: Self-evaluation test, Social Support Questionnaire, Beck Depression Inventory II (BDI II), MacNew Heart Disease Health-Related Quality of Life Questionnaire, State-Trait Anxiety Inventory (STAI), State-Trait Anger Expression Inventory (STAXI 2).
In two distinct following meetings, an open questionnaire exploring the body and emotional perception, and another exploring past and recent dreams, will be administered.
The same evaluation will be done for the healthy subjects.
After the initial evaluation, all the patients will be given the choice to start a short-term psychotherapy lasting 6 months on top of medical therapy or to continue classic medical therapy only. Healthy subjects will be not offered the possibility to follow psychotherapy.
At first year of follow-up, the battery of psychometric test, and the two questionnaires exploring the body and emotional perception, and changes and characteristics of dreams during the psychotherapy, will be re-administered.
The following data will be evaluated:
Psychological characteristics at follow-up. Incidence of new relevant medical events Quality of life Relationship between psychological characteristics and health status, and quality of life
At 5 year follow-up psychometric tests and the clinical data will be evaluated in all the groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients within one week from an Acute myocardial infarction treated with primary or urgent PCI
- •Patients within one week from the onset of Tako Tsubo cardiomyopathy.
- •Patients with a diagnosis of breast cancer in the preceding six months
- •Age and sex matched control subjects without relevant medical pathologies in the preceding 10 years
排除标准
- •Cognitive impairment
- •Refusing the enrolment
结局指标
主要结局
Cumulative incidence of new relevant medical events
时间窗: at 1 year
Relevant medical events are defined as any new medical condition significantly impairing normal daily activities or requiring hospitalization or needing specific and permanent drug treatment.
次要结局
- Changes in body perception and dreams(at 1 year)
- Social support(at 5 year)
- Quality of life(at 5 years)
- Anxiety grade(At 5 years)
- Incidence of rehospitalisations(at 5 years)
- Anger level(at 5 years)
- Cumulative incidence of new relevant medical events(at 5 years)
- Distress grade(at 5 years)
- Depression symptoms(at 5 years)
研究者
Christian Pristipino
MD, Head of Research and Training section, Interventional Cardiology Unit
San Filippo Neri General Hospital