MIND: Psychological Predictors in Colorectal Cancer Surgery Recovery

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Unknown status

CT.gov ID

NCT03781193

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Other: Questionnaires administration Other: Five Facet Mindfulness Questionnaire (FFMQ) Other: Langer Mindfulness Scale (LMS) Other: Cognitive Flexibility Scale (CFS) Other: Life Orientation Test (LOT) Other: Mini Locus of Control test (MLS) Other: Hospital Anxiety and Depression Scale (HADS) Other: Perceived Stress Scale (PSS) Other: Toronto Alexithymia Scale (TAS)

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 6, 2018

Anticipated Primary Completion Date :

Mar 6, 2019

Anticipated Study Completion Date :

Jul 6, 2019

Outcome Measures

Primary Outcome Measures

Correlation between psychological predictors questionnaires outcome and length of hospital stay [Post-operative day 7]
Length of stay calculated in days from the day of surgery until the day of discharge
Correlation between psychological predictors questionnaires outcome and quality of life [Post-operative day 90]
Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer Quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)
Correlation between psychological predictors questionnaires outcome and quality of life [Post-operative month 6]
Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)
Correlation between psychological predictors questionnaires outcome and quality of life [Post-operative month 12]
Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer Quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery	Milan	MI	Italy	20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

Principal Investigator: Antonino Spinelli, MD, PhD, Istituto Clinico Humanitas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Clinico Humanitas

ClinicalTrials.gov Identifier:

NCT03781193

Other Study ID Numbers:

1945

First Posted:

Dec 19, 2018

Last Update Posted:

Dec 20, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Istituto Clinico Humanitas

mindfulness

Psychological predictors

Colorectal surgery

ERAS

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Dec 20, 2018