Psychological distREsS hipEc oR pelVic Exenteration

Recruiting

• Conditions: Colo-rectal Cancer

• Registration Number: NCT04956107
• Lead Sponsor: University of Aarhus

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.

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 Timeline

• Study Start: 2021-01-25
• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-07-09
• Status Verified: 2022-11
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of sleeping issues after PE or CRS+HIPEC for colorectal cancer	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	Descriptive analysis will be done using following the questionnaire: ISI (insomnia sleep index)
Development of ´fear of cancer recurrence' after PE or CRS+HIPEC for colorectal cancer	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	Descriptive analysis will be done using following the questionnaire: Fear of cancer recurrence - SF
Development of anxiety after PE or CRS+HIPEC for colorectal cancer	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	Descriptive analysis will be done using the following questionnaire: GAD-7 (general anxiety disorder)
Development of depression after PE or CRS+HIPEC for colorectal cancer	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	Descriptive analysis will be done using the following questionnaire: PHQ-9 (patient health questionnaire)
Development of cognitive dysfunction after PE or CRS+HIPEC for colorectal cancer	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	Descriptive analysis will be done using following the questionnaire: Items regarding cognitive functioning from the EORTC item library
Development of fatigue after PE or CRS+HIPEC for colorectal cancer	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	Descriptive analysis will be done using following the questionnaire: FACIT V4 (fatigue scale)

Secondary Outcome Measures

Name	Time	Method
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.	Univariate and multivariate regression analysis will be performed to identify potential risk

Trial Locations

Locations (3)

Department of Surgery, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Department of Surgery, Skånes University Hospital, Malmö; 🇸🇪 Malmö, Sweden

Department of Surgery, Karolinska University Hospital; 🇸🇪 Solna, Stockholm, Sweden