Psyhosomatic Medicine in Oncologic and Cardiac Disease Study (PSYCHONIC)

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Acute Myocardial Infarction; Tako Tsubo Cardiomyopathy
• Intervention / Treatment: Behavioral: Short Term Psychotherapy

• Study Type: Observational
• Enrollment (Anticipated): 220

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00135
    • Recruiting
    • San Filippo Neri General Hospital
    • Contact: Adriana Roncella, MD; Phone Number: 0633062504; Email: adriana.roncella@aslroma1.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tako-Tsubo - STP; Short term psychotherapy + Classic cardiological therapy	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
Tako-Tsubo - Control; Classic cardiological therapy only
Oncologic - STP; Short term psychotherapy + Classic oncological therapy	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
Oncologic - Control; Classic oncological therapy only
AMI - STP; Short term psychotherapy + Classic cardiological therapy	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
AMI - Control; Classic cardiological therapy only
Healthy Subjects; No therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in body perception and dreams	These changes will be evaluated with dedicated qualitative questionnaires formulated with open questions.	at 1 year
Incidence of rehospitalisations	Number of rehospitalisations during the first year of follow-up	at 1 year
Incidence of rehospitalisations	Number of rehospitalisations during 5 years follow-up	at 5 years
Distress grade	Self-evaluation test (score range 1-10, higher stress for higher values)	at 1 year
Distress grade	Self-evaluation test (score range 1-10, higher stress for higher values)	at 5 years
Depression symptoms	Beck depression inventory II (score range 0-63, more severe depression symptoms for higher values)	at 1 year
Depression symptoms	Beck depression inventory II (score range 0-63, more severe depression symptoms for higher values)	at 5 years
Social support	Social support questionnaire (score range 12-72, the higher the score the lower the support)	at 1 year
Social support	Social support questionnaire (score range 12-72, the higher the score the lower the support)	at 5 year
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
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
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
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
Anger level	State-Trait Anger Expression inventory (score range 0%-100%, the higher the score the higher the anger, two subscales)	at 1 year
Anger level	State-Trait Anger Expression inventory (score range 0%-100%, the higher the score the higher the anger, two subscales)	at 5 years

Collaborators and Investigators

• Sponsor: San Filippo Neri General Hospital
• Investigators: Principal Investigator: Adriana Roncella, MD, San Filippo Neri General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 27, 2018
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: December 22, 2017
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (ACTUAL): February 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Myocardial Infarction; Infarction; Cardiomyopathies; Takotsubo Cardiomyopathy
• Other Study ID Numbers: v24-9-2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No