UnknownNot Applicable

Psychological distREsS hipEc oR pelVic Exenteration

Denmark, Sweden225 participantsStarted 2021-01-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Development of depression after PE or CRS+HIPEC for colorectal cancer

Timeframe: 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

Development of cognitive dysfunction after PE or CRS+HIPEC for colorectal cancer

Development of sleeping issues after PE or CRS+HIPEC for colorectal cancer

Development of fatigue after PE or CRS+HIPEC for colorectal cancer

Trial details

NCT IDNCT04956107

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-01

Contact for this trial

Rogini Balachandran, MD

+4542400620 rogbal@rm.dk

View on ClinicalTrials.gov More Colo-rectal Cancer trials