Questionnaires administration and Five Facet Mindfulness Questionnaire (FFMQ) and Langer Mindfulness Scale (LMS) in Colorectal Cancer - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Colorectal Cancer

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 Time Frame: Post-operative day 7	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 Time Frame: 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)	Post-operative day 90
Correlation between psychological predictors questionnaires outcome and quality of life Time Frame: 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)	Post-operative month 6
Correlation between psychological predictors questionnaires outcome and quality of life Time Frame: 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)	Post-operative month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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