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.

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433146
• Other study ID #: 65422-SU-CE
• Status: Completed
• Phase: N/A
• First received: September 10, 2011
• Last updated: June 4, 2012
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Colorectal Cancer
• Colorectal Neoplasms
• Depression
• Depressive Disorder
• Temperament

Locations

Country	Name	City	State
Italy	"Sapienza" University of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Kohno Y, Maruyama M, Matsuoka Y, Matsushita T, Koeda M, Matsushima E. Relationship of psychological characteristics and self-efficacy in gastrointestinal cancer survivors. Psychooncology. 2010 Jan;19(1):71-6. doi: 10.1002/pon.1531. — View Citation

Nan KJ, Wei YC, Zhou FL, Li CL, Sui CG, Hui LY, Gao CG. Effects of depression on parameters of cell-mediated immunity in patients with digestive tract cancers. World J Gastroenterol. 2004 Jan 15;10(2):268-72. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperament in non-metastatic colorectal cancer patients	Evaluation if Temperament can be considered as dependent or indipendent prognostic factor for survival in non-metastatic colorectal cancer patients	24 months	Yes