Clinical Stories and Psychological Experiences of Cancer... | NCT06109896

Studies
Clinical Stories and Psychological Experiences of Cancer Patients

NCT06109896

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Not yet recruiting

Last Update Posted

Oct 31, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Tumor

Interventions

Self Report Questionaires

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2023Estimated

Primary Completion Date

Oct 31, 2025Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Oct 26, 2023

First Submission Date that Met QC Criteria

Oct 26, 2023

First Posted Date

Oct 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2023

Last Update Posted Date

Oct 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Self Report Questionaires	Other	Collection and analysis of information from patient self-report assessments and integration with clinical information from assessments performed routinely during cancer treatment.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample