Psychological Predictors in Colorectal Cancer Surgery Recovery

• Conditions: Colorectal Cancer

• Registration Number: NCT03781193
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study Start: 2018-03-06
• Status Verified: 2018-12
• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-20
• Primary Completion: 2019-03-06
• Study Completion: 2019-07-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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)

Trial Locations

Locations (1)

IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery; 🇮🇹 Milan, MI, Italy