Psychological distREsS hipEc oR pelVic Exenteration

NCT04956107 | Unknown

• 1 other identifier: Preserve
• Study Type: observational
• Target: 225
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Colo-rectal Cancer

Keywords

cytoreductive surgery; hyperthermic intraperitoneal chemotherapy; pelvic exenteration; adverse effects; psychological distress; anxiety; depression; fear of cancer recurrence; cognitive dysfunction; quality of life

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Risk factors associated with developing psychological distress

  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.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Karolinska University Hospital: collaborator
• Skane University Hospital: collaborator

Study Sites (3)

Department of Surgery, Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Department of Surgery, Karolinska University Hospital

Solna, Stockholm County, 17164, Sweden

NOT YET RECRUITING

Department of Surgery, Skånes University Hospital, Malmö

Malmo, 21428, Sweden

NOT YET RECRUITING

Related Publications (1)

• Balachandran R, Thaysen HV, Christensen P, Zachariae R, Iversen LH. Biopsychosocial Late Effects After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Metastases from Colorectal and Appendiceal Cancer: A National Prospective Cohort Study. Ann Surg Oncol. 2024 Mar;31(3):1959-1969. doi: 10.1245/s10434-023-14618-6. Epub 2023 Dec 21.

  PMID: 38127212 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Anxiety Disorders; Depression; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Rogini Balachandran, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rogini Balachandran, MD

CONTACT

+4542400620; rogbal@rm.dk

Lene H Iversen, Professor

CONTACT

d268143@dadlnet.dk

Study Design

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

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 9, 2021
• Study Start: January 25, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 28, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); DK (1)