Clinical Stories and Psychological Experiences of Cancer Patients

ONCO_STORIES. Stress, Trauma, Origins, Psychological Responses, Interpersonal Relationships and Experiences in the Clinical History of Cancer Patients

The purpose of the study is to collect and analyze information from the multidimensional assessment of cancer patients (medical, psychological, psychometric, biological, etc.) treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The collection of information will allow to investigate the possible presence of correlations between psychological aspects and clinical medical conditions of the person during the course/treatment of cancer.

In the course of the study, the possible presence of previous stressful and/or traumatic events, and the presence of psychological, post-traumatic and/or dissociative symptoms during treatment will be explored. Any correlations between medical conditions and psychological, emotional and behavioral characteristics will also be explored. Finally, it will be possible to investigate the effectiveness of psychological interventions that are carried out according to clinical practice.

Study Overview

• Status: Not yet recruiting
• Conditions: Tumor
• Intervention / Treatment: Other: Self Report Questionaires

• Study Type: Observational
• Enrollment (Estimated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients who have been diagnosed with cancer. Patients who access the services of: Gynecology Oncology Unit, Internal Medicine and Gastroenterology Unit, Digestive Surgery Unit, Radiotherapy Oncology Unit, Senology Surgery Unit, Medical Oncology Unit, Hematology Unit, Medicine Unit will be considered.

Neurosurgery and at the same time as psychological consultation with the operators belonging to the Clinical Psychology Unit of Fondazione Policlinico Universitario A. Gemelli IRCSS.

Description

Inclusion Criteria:

• Individuals between 18 and 99 years old;
• Individuals with a diagnosis of current oncologic disease and in active oncologic treatment at the hospital where the study is conducted;
• Individuals with a history of oncologic disease who have completed oncologic treatment or in follow-up at the hospital where the study is conducted;

Exclusion Criteria:

• Non-signing of informed consent;
• Non-signing of consent/assent by patient/legal guardian;
• Patients with cognitive impairment or legal disqualification;
• Clinical/medical or psychological condition that does not allow completion of self-report questionnaires;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect and analyze information from the multidimensional assessment of cancer patients	Descriptive and statistical analysis of data collected on the clinical and psychological conditions of the cancer patient through routine assessments and self-report questionnaires.	1 hour

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 5913 (CTEP)

Drug and device information, study documents

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