Psychological Predictors in Colorectal Cancer Surgery Recovery
NCT ID: NCT03781193
Last Updated: 2018-12-20
Study Results
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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UNKNOWN
40 participants
OBSERVATIONAL
2018-03-06
2019-07-06
Brief Summary
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Detailed Description
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In particular, mindfulness is proved to be associated with higher quality of life in different medical conditions, including oncological patients and has been also associated with improved clinical outcomes.
The aim of the study is to investigate the association of mindfulness and other psychological predictors with functional and quality of life outcomes in patients undergoing colorectal surgery for oncological condition.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Questionnaires administration
Psychological and quality of life questionnaires
Five Facet Mindfulness Questionnaire (FFMQ)
FFMQ is a 39-item measure consisting of five subscales (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience).
Langer Mindfulness Scale (LMS)
The LMS Tis a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility.
Cognitive Flexibility Scale (CFS)
The CFS is 12-item self-report test assessing awareness.
Life Orientation Test (LOT)
The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.
Mini Locus of Control test (MLS)
The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.
Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-items rated on a four-point Likert scale. The questionnaire was designed to screen for the presence and severity of depression (HADS-D) and anxiety (HADS-A) in people with a physical symptomatology
Perceived Stress Scale (PSS)
The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.
Toronto Alexithymia Scale (TAS)
The TSA is a 20-item scale that evaluates the three components of alexithymia: difficulty to identify feelings and distinguish between feelings and bodily sensations of emotional arousal difficulty, describing feelings to others, and a cognitive style that is literal, utilitarian, and externally oriented.
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with colorectal cancer.
* Patients scheduled for elective open or laparoscopic surgery for curative intent.
Exclusion Criteria
* Patients \< 18 years old.
* Patients undergoing surgery in emergency setting.
* Patients with pre-operative evidence of metastatic cancer or colorectal cancer recurrence.
* Pregnant or breastfeeding patients.
* Any condition that, in the opinion of the investigator, can interfere with the study protocol (e.g. neuropsychiatric disorders or dementia).
18 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Principal Investigators
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Antonino Spinelli, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Istituto Clinico Humanitas
Locations
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IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery
Milan, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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Annalisa Maroli, PhD
Role: primary
Other Identifiers
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1945
Identifier Type: -
Identifier Source: org_study_id