Adaptation, PsychologicalNCT01675505
Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery
An observational study of Adaptation, Psychological and Functional Insufficiency, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Adaptation, Psychological, Functional Insufficiency
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- May 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Patients with first-diagnosed colon cancer.
- Age 18-60 years
Who cannot join
- Metastatic colon cancer.
- Former psychiatric history.
- Substance use.
- Previous serious medical conditions.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Greece, 1st Propedeutic Surgical Department, AHEPA General University Hospital
Thessaloniki, 54636
Diomidis Antoniadis, Phd Student, 00306993944616, dio_psych@yahoo.gr
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adaptation, PsychologicalStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoniadis Diomidis, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675505
- Sponsor's protocol ID
- Phd Antoniadis
- Status last verified
- Jul 2013
- First submitted
- 28 Aug 2012
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery
- ClinicalTrials.gov ID
- NCT01675505
- Acronym / sponsor ID
- Phd Antoniadis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- May 2012
- First posted
- 30 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Patients with first-diagnosed colon cancer.
- Age 18-60 years
Key exclusion criteria (4 listed)
- Metastatic colon cancer.
- Former psychiatric history.
- Substance use.
- Previous serious medical conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
- BackgroundJimmie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adaptation, Psychological and Functional Insufficiency, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diomidis Antoniadis, Phd Student (00306993944616, dio_psych@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01675505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.