Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT01675505
Status:
UNKNOWN
Last Update Posted:
2013-07-11
First Post:
2012-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2012-08-28', 'studyFirstSubmitQcDate': '2012-08-29', 'lastUpdatePostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adaptation, Psychological', 'Functional Insufficiency']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nMoreover this is the first study using the Distress Thermometer in Greek patients with cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with first-diagnosed colon cancer.\n* Age 18-60 years\n\nExclusion Criteria:\n\n* Metastatic colon cancer.\n* Former psychiatric history.\n* Substance use.\n* Previous serious medical conditions.'}, 'identificationModule': {'nctId': 'NCT01675505', 'briefTitle': 'Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery', 'orgStudyIdInfo': {'id': 'Phd Antoniadis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Inclusion criteria:\n\nPatients with first-diagnosed colon cancer. Age 18-60 y.o.\n\nExclusion criteria:\n\nMetastatic colon cancer. Former psychiatric history. Substance use. Previous serious medical conditions.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54636', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Diomidis Antoniadis, Phd Student', 'role': 'CONTACT', 'email': 'dio_psych@yahoo.gr', 'phone': '00306993944616'}], 'facility': 'Greece, 1st Propedeutic Surgical Department, AHEPA General University Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'Diomidis Antoniadis, Phd Student', 'role': 'CONTACT', 'email': 'dio_psych@yahoo.gr', 'phone': '00306993944616'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd student', 'investigatorFullName': 'Antoniadis Diomidis', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}