Psychological Predictors in Colorectal Cancer Surgery Recovery (MIND)

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20089
      • Recruiting
      • IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery
      • Contact: Annalisa Maroli, PhD; Phone Number: 0282247776; Email: annalisa.maroli@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Colorectal cancer patients scheduled for elective curative colorectal surgery.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between psychological predictors questionnaires outcome and length of hospital stay	Length of stay calculated in days from the day of surgery until the day of discharge	Post-operative day 7
Correlation between psychological predictors questionnaires outcome and quality of life	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)	Post-operative day 90
Correlation between psychological predictors questionnaires outcome and quality of life	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)	Post-operative month 6
Correlation between psychological predictors questionnaires outcome and quality of life	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)	Post-operative month 12

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Anticipated): March 6, 2019
• Study Completion (Anticipated): July 6, 2019

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Colorectal surgery; mindfulness; ERAS; Psychological predictors
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 1945

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No