Clinical trial NCT03437642: Psyhosomatic Medicine in Oncologic and Cardiac Disease Study
Official title: Retrospective and Prospective Observational Study on Cardiological and Oncological Psychosomatics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Tako Tsubo Cardiomyopathy
Breast Cancer
Lead sponsor: San Filippo Neri General Hospital
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of new relevant medical events
timeFrame: at 1 year
Secondary outcomes:
measure: Cumulative incidence of new relevant medical events
timeFrame: at 5 years
measure: Changes in body perception and dreams
timeFrame: at 1 year
measure: Incidence of rehospitalisations
timeFrame: at 1 year
measure: Incidence of rehospitalisations
timeFrame: at 5 years
measure: Distress grade
timeFrame: at 1 year
measure: Distress grade
timeFrame: at 5 years
measure: Depression symptoms
timeFrame: at 1 year
measure: Depression symptoms
timeFrame: at 5 years
measure: Social support
timeFrame: at 1 year
measure: Social support
timeFrame: at 5 year
measure: Quality of life
timeFrame: at 1 year
measure: Quality of life
timeFrame: at 5 years
measure: Anxiety grade
timeFrame: At 1 year
measure: Anxiety grade
timeFrame: At 5 years
measure: Anger level
timeFrame: at 1 year
measure: Anger level
timeFrame: at 5 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: San Filippo Neri General Hospital
Study officials:
affiliation: San Filippo Neri General Hospital
name: Adriana Roncella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roncella A, Pristipino C, Di Carlo O, Ansuini M, Corbosiero A, Di Fusco SA, Palumbo G, Gigantesco A, Mirabella F, De Angelis R, Pasceri V, Cancellara L, Colivicchi F, Allan R, Mirri MA, Speciale G. PSYChosomatic Medicine in ONcologIc and Cardiac Disease (PSYCHONIC) Study-A Retrospective and Prospective Observational Research Protocol. J Clin Med. 2021 Dec 10;10(24):5786. doi: 10.3390/jcm10245786.