NCT03781193

Psychological Predictors in Colorectal Cancer Surgery Recovery

Psychological Predictors of Post-surgical Recovery in Colorectal Cancer Patients: a Pilot Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observation pilot trial aimed to study to the association between mindfulness and other psychological factors, including both protective and risk factors, with recovery of functional ability following colorectal cancer surgery.

Detailed description

Preliminary evidence suggests that there are multiple variables that may influence the functional recovery following colorectal cancer surgery, some of which deal with the psychological domain. Distress and depression can negatively affect the perceptions of functional ability, while resilience and effective coping styles promote a better psychological adaptation to challenging situations. Furthermore, psychosocial prehabilitation and interventions have been proposed as a feasible and cost-effective way to positively influence the recovery after surgery in association with the Enhanced Recovery After Surgery (ERAS) protocol. 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

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	Questionnaires administration	Psychological and quality of life questionnaires
OTHER	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).
OTHER	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.
OTHER	Cognitive Flexibility Scale (CFS)	The CFS is 12-item self-report test assessing awareness.
OTHER	Life Orientation Test (LOT)	The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.
OTHER	Mini Locus of Control test (MLS)	The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.
OTHER	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
OTHER	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.
OTHER	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.

Timeline

• Start date: 2018-03-06
• Primary completion: 2019-03-06
• Completion: 2019-07-06
• First posted: 2018-12-19
• Last updated: 2018-12-20

Locations

1 site across 1 country: Italy