Psychological Predictors in Colorectal Cancer Surgery Recovery

NCT03781193 | Unknown

• 1 other identifier: 1945
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

mindfulness; Psychological predictors; Colorectal surgery; ERAS

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Questionnaires administration OTHER

Psychological and quality of life questionnaires

Five Facet Mindfulness Questionnaire (FFMQ) OTHER

FFMQ is a 39-item measure consisting of five subscales (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience).

Langer Mindfulness Scale (LMS) OTHER

The LMS Tis a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility.

Cognitive Flexibility Scale (CFS) OTHER

The CFS is 12-item self-report test assessing awareness.

Life Orientation Test (LOT) OTHER

The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.

Mini Locus of Control test (MLS) OTHER

The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.

Hospital Anxiety and Depression Scale (HADS) OTHER

The HADS is a 14-items rated on a four-point Likert scale. The questionnaire was designed to screen for the presence and severity of depression (HADS-D) and anxiety (HADS-A) in people with a physical symptomatology

Perceived Stress Scale (PSS) OTHER

The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.

Toronto Alexithymia Scale (TAS) OTHER

The TSA is a 20-item scale that evaluates the three components of alexithymia: difficulty to identify feelings and distinguish between feelings and bodily sensations of emotional arousal difficulty, describing feelings to others, and a cognitive style that is literal, utilitarian, and externally oriented.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Colorectal cancer patients scheduled for elective curative colorectal surgery.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery

Milan, MI, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone; Perceived Stress Scale

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Antonino Spinelli, MD, PhD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Maroli, PhD

CONTACT

+.39 02 8224 7776; annalisa.maroli@humanitas.it

Francesca De Lucia, MD

CONTACT

+39 028224 7776; francesca.delucia@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 19, 2018
• Study Start: March 6, 2018
• Primary Completion: March 6, 2019
• Study Completion: July 6, 2019
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)