Heart and Blood Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Myocardial Infarction

Infarction

Heart Diseases

Breast Neoplasms

Cardiomyopathies

Takotsubo Cardiomyopathy

Ischemia

Necrosis

Coronary Artery Disease

Myocardial Ischemia

Vascular Diseases

Ventricular Dysfunction, Left

Ventricular Dysfunction

Acute Graft Versus Host Disease

Broken Heart Syndrome

Short term psychotherapy + Classic cardiological therapy

Short term psychotherapy + Classic oncological therapy

Humanistic-existential psychotherapy derived from ontopsychological method and specifically adapted to public health systems. Individual and group sessions to be tailored to individual needs

Short Term Psychotherapy

Adriana Roncella, MD

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.

Psyhosomatic Medicine in Oncologic and Cardiac Disease Study

Retrospective and Prospective Observational Study on Cardiological and Oncological Psychosomatics

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.

These changes will be evaluated with dedicated qualitative questionnaires formulated with open questions.

Number of rehospitalisations during the first year of follow-up

Number of rehospitalisations during 5 years follow-up

Self-evaluation test (score range 1-10, higher stress for higher values)

Beck depression inventory II (score range 0-63, more severe depression symptoms for higher values)

Social support questionnaire (score range 12-72, the higher the score the lower the support)

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)

State-Trait Anxiety inventory (score range 20-80, the higher the score the more anxiety the patients has, 2 subscales)

State-Trait Anger Expression inventory (score range 0%-100%, the higher the score the higher the anger, two subscales)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Psyhosomatic Medicine in Oncologic and Cardiac Disease Study	NCT03437642	Acute Myocardia... Tako Tsubo Card... Breast Cancer	Short Term Psyc...	18 Years - 75 Years	San Filippo Neri General Hospital
Psyhosomatic Medicine in Oncologic and Cardiac Disease Study	NCT03437642	Acute Myocardia... Tako Tsubo Card... Breast Cancer	Short Term Psyc...	18 Years - 75 Years	San Filippo Neri General Hospital

Spots Global Cancer Trial Database for tako tsubo cardiomyopathy