Breast Cancer Clinical Trial
Official title:
Retrospective and Prospective Observational Study on Cardiological and Oncological Psychosomatics
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.
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