Psyhosomatic Medicine in Oncologic and Cardiac Disease Study
NCT ID: NCT03437642
Last Updated: 2019-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
220 participants
OBSERVATIONAL
2018-03-27
2022-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Oncologic - Control
Classic oncological therapy only
No interventions assigned to this group
AMI - STP
Short term psychotherapy + Classic cardiological therapy
Short Term Psychotherapy
Humanistic-existential psychotherapy derived from ontopsychological method and specifically adapted to public health systems. Individual and group sessions to be tailored to individual needs
AMI - Control
Classic cardiological therapy only
No interventions assigned to this group
Healthy Subjects
No therapy
No interventions assigned to this group
Tako-Tsubo - STP
Short term psychotherapy + Classic cardiological therapy
Short Term Psychotherapy
Humanistic-existential psychotherapy derived from ontopsychological method and specifically adapted to public health systems. Individual and group sessions to be tailored to individual needs
Tako-Tsubo - Control
Classic cardiological therapy only
No interventions assigned to this group
Oncologic - STP
Short term psychotherapy + Classic oncological therapy
Short Term Psychotherapy
Humanistic-existential psychotherapy derived from ontopsychological method and specifically adapted to public health systems. Individual and group sessions to be tailored to individual needs
Interventions
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Short Term Psychotherapy
Humanistic-existential psychotherapy derived from ontopsychological method and specifically adapted to public health systems. Individual and group sessions to be tailored to individual needs
Eligibility Criteria
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Inclusion Criteria
* 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
* Refusing the enrolment
18 Years
75 Years
ALL
No
Sponsors
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San Filippo Neri General Hospital
OTHER
Responsible Party
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Christian Pristipino
MD, Head of Research and Training section, Interventional Cardiology Unit
Principal Investigators
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Adriana Roncella, MD
Role: PRINCIPAL_INVESTIGATOR
San Filippo Neri General Hospital
Locations
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San Filippo Neri General Hospital
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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v24-9-2017
Identifier Type: -
Identifier Source: org_study_id
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