NCT04956107

Psychological distREsS hipEc oR pelVic Exenteration

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 225 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colo-rectal Cancer

Timeline

• Start date: 2021-01-25
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2021-07-09
• Last updated: 2023-02-28

Locations

3 sites across 2 countries: Denmark, Sweden