Psyhosomatic Medicine in Oncologic and Cardiac Disease Study

NCT03437642 | Unknown

• 1 other identifier: v24-9-2017
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction; Tako Tsubo Cardiomyopathy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Cumulative incidence of new relevant medical events

  at 5 years

• Changes in body perception and dreams

  at 1 year

• Incidence of rehospitalisations

  at 1 year

• Incidence of rehospitalisations

  at 5 years

• Distress grade

  at 1 year

Study Arms (7)

Tako-Tsubo - STP

Short term psychotherapy + Classic cardiological therapy

Behavioral: Short Term Psychotherapy

Tako-Tsubo - Control

Classic cardiological therapy only

Oncologic - STP

Short term psychotherapy + Classic oncological therapy

Behavioral: Short Term Psychotherapy

Oncologic - Control

Classic oncological therapy only

AMI - STP

Short term psychotherapy + Classic cardiological therapy

Behavioral: Short Term Psychotherapy

AMI - Control

Classic cardiological therapy only

Healthy Subjects

No therapy

Interventions

Short Term Psychotherapy BEHAVIORAL

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 - STP; Oncologic - STP; Tako-Tsubo - STP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment
• Refusing the enrolment

Sponsors & Collaborators

• San Filippo Neri General Hospital: lead

Study Sites (1)

San Filippo Neri General Hospital

Roma, 00135, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 34945081 DERIVED

MeSH Terms

Conditions

Takotsubo Cardiomyopathy; Breast Neoplasms

Interventions

Psychotherapy, Brief

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Adriana Roncella, MD

  San Filippo Neri General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana Roncella, MD

CONTACT

+39060633062504; adrianaroncella@hotmail.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Head of Research and Training section, Interventional Cardiology Unit

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: February 19, 2018
• Study Start: March 27, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 18, 2019

Record last verified: 2019-09

Locations

IT (1)