Psyhosomatic Medicine in Oncologic and Cardiac Disease Study

Study Overview
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Brief Summary
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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.

Official Title
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Retrospective and Prospective Observational Study on Cardiological and Oncological Psychosomatics

Conditions
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Acute Myocardial Infarction, Tako Tsubo Cardiomyopathy, Breast Cancer

Intervention / Treatment
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* Behavioral: Short Term Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Cognitive impairment Refusing the enrolment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tako-Tsubo - STP<br>Short term psychotherapy + Classic cardiological therapy | Behavioral: Short Term Psychotherapy<br>* Humanistic-existential psychotherapy derived from ontopsychological method and specifically adapted to public health systems. Individual and group sessions to be tailored to individual needs<br>|
| Tako-Tsubo - Control<br>Classic cardiological therapy only | |
| Oncologic - STP<br>Short term psychotherapy + Classic oncological therapy | Behavioral: Short Term Psychotherapy<br>* Humanistic-existential psychotherapy derived from ontopsychological method and specifically adapted to public health systems. Individual and group sessions to be tailored to individual needs<br>|
| Oncologic - Control<br>Classic oncological therapy only | |
| AMI - STP<br>Short term psychotherapy + Classic cardiological therapy | Behavioral: Short Term Psychotherapy<br>* Humanistic-existential psychotherapy derived from ontopsychological method and specifically adapted to public health systems. Individual and group sessions to be tailored to individual needs<br>|
| AMI - Control<br>Classic cardiological therapy only | |
| Healthy Subjects<br>No therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of new relevant medical events | 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. | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of new relevant medical events | 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. | at 5 years | 
| Changes in body perception and dreams | These changes will be evaluated with dedicated qualitative questionnaires formulated with open questions. | at 1 year | 
| Incidence of rehospitalisations | Number of rehospitalisations during the first year of follow-up | at 1 year | 
| Incidence of rehospitalisations | Number of rehospitalisations during 5 years follow-up | at 5 years | 
| Distress grade | Self-evaluation test (score range 1-10, higher stress for higher values) | at 1 year | 
| Distress grade | Self-evaluation test (score range 1-10, higher stress for higher values) | at 5 years | 
| Depression symptoms | Beck depression inventory II (score range 0-63, more severe depression symptoms for higher values) | at 1 year | 
| Depression symptoms | Beck depression inventory II (score range 0-63, more severe depression symptoms for higher values) | at 5 years | 
| Social support | Social support questionnaire (score range 12-72, the higher the score the lower the support) | at 1 year | 
| Social support | Social support questionnaire (score range 12-72, the higher the score the lower the support) | at 5 year | 
| Quality of life | Mac New Health-related quality of life questionnaire (score range 1-7, the higher the score the higher the quality of life, 4 subscales not merged) | at 1 year | 
| Quality of life | Mac New Health-related quality of life questionnaire (score range 1-7, the higher the score the higher the quality of life, 4 subscales not merged) | at 5 years | 
| Anxiety grade | State-Trait Anxiety inventory (score range 20-80, the higher the score the more anxiety the patients has, 2 subscales) | At 1 year | 
| Anxiety grade | State-Trait Anxiety inventory (score range 20-80, the higher the score the more anxiety the patients has, 2 subscales) | At 5 years | 
| Anger level | State-Trait Anger Expression inventory (score range 0%-100%, the higher the score the higher the anger, two subscales) | at 1 year | 
| Anger level | State-Trait Anger Expression inventory (score range 0%-100%, the higher the score the higher the anger, two subscales) | at 5 years |