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

NCT ID: NCT01675505

Last Updated: 2013-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adaptation, Psychological Functional Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Antoniadis Diomidis

Phd student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Diomidis Antoniadis, Phd Student

Role: CONTACT

00306993944616

Facility Contacts

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Diomidis Antoniadis, Phd Student

Role: primary

00306993944616

References

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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.

Reference Type BACKGROUND

Other Identifiers

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Phd Antoniadis

Identifier Type: -

Identifier Source: org_study_id

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