Effect of Temperament, Anxiety and Depression on Immuninity in Colorectal Cancer Patients. Effetti Del Temperamento, Dell'Ansia e Della Depressione Sulla Sopravvivenza Globale e Sulla Risposta Immunitaria Del Paziente Affetto da Adenocarcinoma Colo-Rettale.

June 4, 2012 updated by: Marco La Torre, University of Roma La Sapienza

Effect of Temperament, Anxiety and Depression on Immuninity in Colorectal Cancer Patients.

Aim of the study is to evaluate if Temperament, Anxiety and Depression can affect Immunity and influence Survival in Colorectal Cancer Patients

Study Overview

Status

Completed

Detailed Description

120 prospective patients, with non-metastatic colorectal cancer, will be evaluated with questionnaires and auto-questionnaires in order to assess temperament, anxiety and depression. The immunity status will be assessed by a blood sample with the aim to evaluate cell-mediated immunity.

Survivall will be related to level of anxiety/temperament/depression and cell-mediated immunity.

Univariate and multivariate model analisys will be performed in order to evaluate if anxiety/temperament/depression and cell-mediated immunity can be considered as prognostic factors.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rome, Italy, 00100
        • "Sapienza" University of Rome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

diagnosis of non-metastatic colorectal cancer

Exclusion Criteria:

previous other primary malignancies immunodepression diagnosis of major deppression diagnosis of anxiety/depression syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temperament in non-metastatic colorectal cancer patients
Time Frame: 24 months
Evaluation if Temperament can be considered as dependent or indipendent prognostic factor for survival in non-metastatic colorectal cancer patients
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marco La Torre, MD, University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

September 10, 2011

First Submitted That Met QC Criteria

September 10, 2011

First Posted (Estimate)

September 13, 2011

Study Record Updates

Last Update Posted (Estimate)

June 6, 2012

Last Update Submitted That Met QC Criteria

June 4, 2012

Last Verified

June 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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