Psyhosomatic Medicine in Oncologic and Cardiac Disease Study

Breast Cancer Clinical Trial

— PSYCHONIC  

Official title:

Retrospective and Prospective Observational Study on Cardiological and Oncological Psychosomatics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03437642
• Other study ID #: v24-9-2017
• Status: Recruiting
• Start date: March 27, 2018
• Est. completion date: December 2022

Study information

• Verified date: September 2019
• Source: San Filippo Neri General Hospital
• Contact: Adriana Roncella, MD
• Phone: +39060633062504
• Email: adrianaroncella[@]hotmail.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Breast Cancer
• Cardiomyopathies
• Infarction
• Myocardial Infarction
• Tako Tsubo Cardiomyopathy
• Takotsubo Cardiomyopathy

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Italy	San Filippo Neri General Hospital	Roma

Sponsors (1)

Lead Sponsor	Collaborator
San Filippo Neri General Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of new relevant medical events	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.	at 1 year
Secondary	Cumulative incidence of new relevant medical events	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.	at 5 years
Secondary	Changes in body perception and dreams	These changes will be evaluated with dedicated qualitative questionnaires formulated with open questions.	at 1 year
Secondary	Incidence of rehospitalisations	Number of rehospitalisations during the first year of follow-up	at 1 year
Secondary	Incidence of rehospitalisations	Number of rehospitalisations during 5 years follow-up	at 5 years
Secondary	Distress grade	Self-evaluation test (score range 1-10, higher stress for higher values)	at 1 year
Secondary	Distress grade	Self-evaluation test (score range 1-10, higher stress for higher values)	at 5 years
Secondary	Depression symptoms	Beck depression inventory II (score range 0-63, more severe depression symptoms for higher values)	at 1 year
Secondary	Depression symptoms	Beck depression inventory II (score range 0-63, more severe depression symptoms for higher values)	at 5 years
Secondary	Social support	Social support questionnaire (score range 12-72, the higher the score the lower the support)	at 1 year
Secondary	Social support	Social support questionnaire (score range 12-72, the higher the score the lower the support)	at 5 year
Secondary	Quality of life	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)	at 1 year
Secondary	Quality of life	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)	at 5 years
Secondary	Anxiety grade	State-Trait Anxiety inventory (score range 20-80, the higher the score the more anxiety the patients has, 2 subscales)	At 1 year
Secondary	Anxiety grade	State-Trait Anxiety inventory (score range 20-80, the higher the score the more anxiety the patients has, 2 subscales)	At 5 years
Secondary	Anger level	State-Trait Anger Expression inventory (score range 0%-100%, the higher the score the higher the anger, two subscales)	at 1 year
Secondary	Anger level	State-Trait Anger Expression inventory (score range 0%-100%, the higher the score the higher the anger, two subscales)	at 5 years