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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marco La Torre, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01433146
First received: September 10, 2011
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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


Condition
Temperament
Anxiety
Depression
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Temperament, Anxiety and Depression on Immuninity in Colorectal Cancer Patients.

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Temperament in non-metastatic colorectal cancer patients [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Evaluation if Temperament can be considered as dependent or indipendent prognostic factor for survival in non-metastatic colorectal cancer patients


Biospecimen Retention:   Samples Without DNA

Blood samples for cell-mediated immunity evaluaion


Estimated Enrollment: 120
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

diagnosis of non-metastatic colorectal cancer

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433146

Locations
Italy
"Sapienza" University of Rome
Rome, Italy, 00100
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Marco La Torre, MD "Sapienza" University of Rome
  More Information

Publications:
Responsible Party: Marco La Torre, Medical Doctor, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01433146     History of Changes
Other Study ID Numbers: 65422-SU-CE
Study First Received: September 10, 2011
Last Updated: June 4, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
Temperament
Anxiety
Depression
Colorectal Cancer

Additional relevant MeSH terms:
Anxiety Disorders
Colorectal Neoplasms
Depression
Depressive Disorder
Mental Disorders
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on July 29, 2014