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Psychological Predictors in Colorectal Cancer Surgery Recovery (MIND)

I

Istituto Clinico Humanitas

Status

Unknown

Conditions

Colorectal Cancer

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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).

Trial contacts and locations

1

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Central trial contact

Francesca De Lucia, MD; Annalisa Maroli, PhD

Data sourced from clinicaltrials.gov

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