Psychological distREsS hipEc oR pelVic Exenteration

Colo-rectal Cancer Clinical Trial

— PRESERVE  

Official title:

Psychological Distress in Colorectal Cancer Patients Following Surgery With Either HIPEC or Pelvic Exenteration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04956107
• Other study ID #: Preserve
• Status: Recruiting
• Start date: January 25, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2022
• Source: University of Aarhus
• Contact: Rogini Balachandran, MD
• Phone: +4542400620
• Email: rogbal[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to describe type and extent of psychological distress (adverse effects) in patients undergoing surgery for colorectal cancer with peritoneal metastases and after surgery for colorectal cancer with involvement of the urinary bladder.

Description:

After being informed about the study all patients giving written informed consent will be distributed a questionnaire asking questions on depression, anxiety, self-reported cognitive issues, sleep issues, quality of life and 'fear of cancer recurrence'. All these aspects will be investigated using validated questionnaires. Once the investigators have the preliminary results (type and extent of psychological distress developed after CRS+HIPEC or PE) the investigators plan to conduct a workshop. In this workshop experts in different areas regarding psychological distress, project leaders, professor from the 'National Center of Late Adverse Effects after Cancer in Pelvic Organs' (Denmark) and patients will participate. With the input of experts and patients, a treatment strategy will be developed, and also an assessment will be made concerning which patients are likely to benefit from treatment by these experts, and which patients could potentially benefit from counselling by their general practitioner or via self-helping tools at home. The investigators plan to conduct this workshop autumn 2021 and start counselling spring 2022.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who have undergone intended curative CRS+HIPEC for peritoneal metastases originated from colorectal cancer (HIPEC cohort) according to national Danish guidelines
• Patients who have undergone intended curative total or anterior pelvic exenteration (PE cohort) for advanced or recurrent colorectal cancer according to national Danish guidelines

Exclusion Criteria:

• Patients under 18 years
• Patients not speaking Danish or Swedish, respectively, in Denmark and Sweden
• Patients unable to give informed consent
• Patients undergoing CRS+HIPEC or PE for cancers others than CRC
• Terminally ill patients

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
Denmark	Department of Surgery, Aarhus University Hospital	Aarhus
Sweden	Department of Surgery, Skånes University Hospital, Malmö	Malmö
Sweden	Department of Surgery, Karolinska University Hospital	Solna	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Karolinska University Hospital, Skane University Hospital

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of depression after PE or CRS+HIPEC for colorectal cancer	Descriptive analysis will be done using the following questionnaire: PHQ-9 (patient health questionnaire)	PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery
Primary	Development of anxiety after PE or CRS+HIPEC for colorectal cancer	Descriptive analysis will be done using the following questionnaire: GAD-7 (general anxiety disorder)	PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery
Primary	Development of cognitive dysfunction after PE or CRS+HIPEC for colorectal cancer	Descriptive analysis will be done using following the questionnaire: Items regarding cognitive functioning from the EORTC item library	PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery
Primary	Development of sleeping issues after PE or CRS+HIPEC for colorectal cancer	Descriptive analysis will be done using following the questionnaire: ISI (insomnia sleep index)	PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery
Primary	Development of fatigue after PE or CRS+HIPEC for colorectal cancer	Descriptive analysis will be done using following the questionnaire: FACIT V4 (fatigue scale)	PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery
Primary	Development of ´fear of cancer recurrence' after PE or CRS+HIPEC for colorectal cancer	Descriptive analysis will be done using following the questionnaire: Fear of cancer recurrence - SF	PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery
Secondary	Risk factors associated with developing psychological distress	Univariate and multivariate regression analysis will be performed to identify potential risk	PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.