Clinical Stories and Psychological Experiences of Cancer Patients

Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06109896
• Other study ID #: 5913
• Status: Not yet recruiting
• Start date: October 31, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: October 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2028
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Tumor

Intervention

Other:
• Self Report Questionaires
Collection and analysis of information from patient self-report assessments and integration with clinical information from assessments performed routinely during cancer treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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