Psyhosomatic Medicine in Oncologic and Cardiac Disease Study (PSYCHONIC)

San Filippo Neri General Hospital

Status: Unknown

Conditions: Breast Cancer; Tako Tsubo Cardiomyopathy; Acute Myocardial Infarction

Treatments: Behavioral: Short Term Psychotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT03437642

v24-9-2017

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

220 participants in 7 patient groups

Tako-Tsubo - STP

Description:

Short term psychotherapy + Classic cardiological therapy

Treatment:

Behavioral: Short Term Psychotherapy

Tako-Tsubo - Control

Description:

Classic cardiological therapy only

Oncologic - STP

Description:

Short term psychotherapy + Classic oncological therapy

Treatment:

Behavioral: Short Term Psychotherapy

Oncologic - Control

Description:

Classic oncological therapy only

AMI - STP

Description:

Short term psychotherapy + Classic cardiological therapy

Treatment:

Behavioral: Short Term Psychotherapy

AMI - Control

Description:

Classic cardiological therapy only

Healthy Subjects

Description:

No therapy