Clinical trial NCT03781193: Psychological Predictors in Colorectal Cancer Surgery Recovery
Official title: Psychological Predictors of Post-surgical Recovery in Colorectal Cancer Patients: a Pilot Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: mindfulness
Psychological predictors
Colorectal surgery
ERAS
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal cancer patients scheduled for elective curative colorectal surgery.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old (both males and females).
* Patients diagnosed with colorectal cancer.
* Patients scheduled for elective open or laparoscopic surgery for curative intent.

Exclusion Criteria:

* Patients unable to give the written informed consent.
* 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).

Primary outcomes:
measure: Correlation between psychological predictors questionnaires outcome and length of hospital stay
timeFrame: Post-operative day 7
measure: Correlation between psychological predictors questionnaires outcome and quality of life
timeFrame: Post-operative day 90
measure: Correlation between psychological predictors questionnaires outcome and quality of life
timeFrame: Post-operative month 6
measure: Correlation between psychological predictors questionnaires outcome and quality of life
timeFrame: Post-operative month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery
state: MI
Study officials:
affiliation: Istituto Clinico Humanitas
name: Antonino Spinelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: