Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03437642
Other study ID # v24-9-2017
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2