Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery

Adaptation, Psychological Clinical Trial

Official title:

Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01675505
• Other study ID #: Phd Antoniadis
• Status: Recruiting
• Phase: N/A
• First received: August 28, 2012
• Last updated: July 9, 2013
• Start date: May 2012

Study information

• Verified date: July 2013
• Source: Aristotle University Of Thessaloniki
• Contact: Diomidis Antoniadis, Phd Student
• Phone: 00306993944616
• Email: dio_psych[@]yahoo.gr
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to investigate whether there are prognostic factors regarding the mental and functional adjustment of colon cancer patients following curative surgery. Patients will be selected using specific inclusion criteria. Prognostic factors investigated include personality characteristics, initial distress, medical, social and economic factors. The utmost purpose of the study is to assist clinicians with the timely identification of vulnerable patients in order to ensure their proper management and their optimal adjustment.

Moreover this is the first study using the Distress Thermometer in Greek patients with cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with first-diagnosed colon cancer.

• Age 18-60 years

Exclusion Criteria:

• Metastatic colon cancer.

• Former psychiatric history.

• Substance use.

• Previous serious medical conditions.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adaptation, Psychological
• Colorectal Neoplasms
• Functional Insufficiency

Locations

Country	Name	City	State
Greece	Greece, 1st Propedeutic Surgical Department, AHEPA General University Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (1)

Jimmie C. Holland, William S. Breitbart, Paul B.Jacobsen, Marguerite S. Lederberg, Matthew J. Loscalzo, Ruth McCorkle. Psycho-oncology, second edition, Oxford University Press, 2010 National Comprehensive Cancer Network. Distress management. Clinical practice guidelines. J Natl Compr Canc Netw. 2003;1:344-74. Ward WL, Hahn EA, Mo F, Hernandez L, Tulsky DS, Cella D. Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument. Qual Life Res. 1999;8:181-95. Watson M, Law M, dos Santos M, Greer S, Baruch J, Bliss J. The Mini-MAC: further development of the Mental Adjustment to Cancer Scale. J Psychosoc Oncol1994;12:33-46.

External Links

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