Psychological distREsS hipEc oR pelVic Exenteration (PRESERVE)

University of Aarhus

Status: Enrolling

Conditions: Colo-rectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04956107

Preserve

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

225 participants in 2 patient groups

HIPEC cohort

Description:

Patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer with peritoneal metastases

PE cohort

Description:

Patients undergoing pelvic exenteration (PE) for colorectal cancer with involvement of the urinary bladder