NCT01675505

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

First QC Date

August 28, 2012

Last Update Submit

July 9, 2013

Conditions

Study Arms (1)

Patients

Inclusion criteria: Patients with first-diagnosed colon cancer. Age 18-60 y.o. Exclusion criteria: Metastatic colon cancer. Former psychiatric history. Substance use. Previous serious medical conditions.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Greek population from Northern Greece who are diagnosed with colon cancer for the first time and are admitted to the 1st Propedeutic Surgical Department of AHEPA General University Hospital of Thessaloniki for surgery.

You may qualify if:

  • Patients with first-diagnosed colon cancer.
  • Age 18-60 years

You may not qualify if:

  • Metastatic colon cancer.
  • Former psychiatric history.
  • Substance use.
  • Previous serious medical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greece, 1st Propedeutic Surgical Department, AHEPA General University Hospital

Thessaloniki, 54636, Greece

RECRUITING

Related 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.

    BACKGROUND

Central Study Contacts

Diomidis Antoniadis, Phd Student

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd student

Study Record Dates

First Submitted

August 28, 2012

First Posted

August 30, 2012

Study Start

May 1, 2012

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations