Psychological distREsS hipEc oR pelVic Exenteration (PRESERVE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colo-rectal Cancer

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 225

Contacts and Locations

• Study Contact: Name: Rogini Balachandran, MD; Phone Number: +4542400620; Email: rogbal@rm.dk
• Study Contact Backup: Name: Lene H Iversen, Professor; Email: d268143@dadlnet.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Department of Surgery, Aarhus University Hospital
    • Contact: Rogini Balachandran, MD; Phone Number: +4542400620; Email: rogbal@rm.dk
• Sweden
  • Malmö, Sweden, 21428
    • Not yet recruiting
    • Department of Surgery, Skånes University Hospital, Malmö
    • Contact: Marie-Louise Lydrup, Ass. Professor
  • Stockholm
    • Solna, Stockholm, Sweden, 17164
      • Not yet recruiting
      • Department of Surgery, Karolinska University Hospital
      • Contact: Per Nilssons, Ass. Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We will prospectively include patients who have undergone surgery at Aarhus University Hospital, Karolinska University Hospital, Stockholm, and Skåne University Hospital, Malmö. Inclusion in Denmark will start February 2021 and in Sweden Summer 2021. Inclusion period is 15 months.

The HIPEC cohort will be established as a cross-sectional study. For newly operated patients, inclusion will happen shortly after surgery with prospective questionnaire follow-ups at 3, 6 and 12 months after inclusion. For patients who have undergone CRS+HIPEC more than 3 months ago, initial inclusion can take place at 6, 12, 18, 24, 36, 48 and 60 months after surgery.

Patients in the PE cohort will be included shortly after surgery with follow-up at 3 months, 6 months and 12 months after surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HIPEC cohort; Patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer with peritoneal metastases
PE cohort; Patients undergoing pelvic exenteration (PE) for colorectal cancer with involvement of the urinary bladder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Karolinska University Hospital; Skane University Hospital
• Investigators: Principal Investigator: Rogini Balachandran, MD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; depression; anxiety; cytoreductive surgery; hyperthermic intraperitoneal chemotherapy; adverse effects; psychological distress; cognitive dysfunction; pelvic exenteration; fear of cancer recurrence
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: PRESERVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No