Psychological distREsS hipEc oR pelVic Exenteration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-25

Study Completion Date

2023-09-01

Brief Summary

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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.

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Detailed Description

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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

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Colo-rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIPEC cohort

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

No interventions assigned to this group

PE cohort

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No