Colo-rectal CancerPRESERVENCT04956107
Psychological distREsS hipEc oR pelVic Exenteration
An observational study of Colo-rectal Cancer, run by University of Aarhus at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer
- How many people
- 225 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 25 Jan 2021to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will prospectively include patients who have undergone surgery at Aarhus University Hospital, Karolinska University Hospital, Stockholm, and Skåne University Hospital, Malmö. Inclusion in Denmark will start February 2021 and in Sweden Summer 2021. Inclusion period is 15 months. The HIPEC cohort will be established as a cross-sectional study. For newly operated patients, inclusion will happen shortly after surgery with prospective questionnaire follow-ups at 3, 6 and 12 months after inclusion. For patients who have undergone CRS+HIPEC more than 3 months ago, initial inclusion can take place at 6, 12, 18, 24, 36, 48 and 60 months after surgery. Patients in the PE cohort will be included shortly after surgery with follow-up at 3 months, 6 months and 12 months after surgery.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 2 countries.
Lene H Iversen, Professor contact
3 sites in 2 countries
Sweden2 sites, 2 recruiting
- Not yet recruiting
Department of Surgery, Skånes University Hospital, Malmö
Malmö, 21428
Marie-Louise Lydrup, Ass. Professor
- Not yet recruiting
Department of Surgery, Karolinska University Hospital
Solna, Stockholm County, 17164
Per Nilssons, Ass. Professor
Denmark1 site, 1 recruiting
- Recruiting
Department of Surgery, Aarhus University Hospital
Aarhus, 8200
Rogini Balachandran, MD, +4542400620, rogbal@rm.dk
About this study
Official title: Psychological Distress in Colorectal Cancer Patients Following Surgery With Either HIPEC or Pelvic Exenteration
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.
Read the 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
- Keywords
- cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, pelvic exenteration, adverse effects, psychological distress, anxiety, depression, fear of cancer recurrence, cognitive dysfunction, quality of life
- Medical subject headings
- Colonic Neoplasms, Anxiety Disorders, Depression, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIPEC cohort | Patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer with peritoneal metastases | |
| PE cohort | Patients undergoing pelvic exenteration (PE) for colorectal cancer with involvement of the urinary bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of depression after PE or CRS+HIPEC for colorectal cancer
Descriptive analysis will be done using the following questionnaire: PHQ-9 (patient health questionnaire)
Measured: 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
Descriptive analysis will be done using the following questionnaire: GAD-7 (general anxiety disorder)
Measured: 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 cognitive dysfunction after PE or CRS+HIPEC for colorectal cancer
Descriptive analysis will be done using following the questionnaire: Items regarding cognitive functioning from the EORTC item library
Measured: 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 sleeping issues after PE or CRS+HIPEC for colorectal cancer
Descriptive analysis will be done using following the questionnaire: ISI (insomnia sleep index)
Measured: 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 fatigue after PE or CRS+HIPEC for colorectal cancer
Descriptive analysis will be done using following the questionnaire: FACIT V4 (fatigue scale)
Measured: 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 ´fear of cancer recurrence' after PE or CRS+HIPEC for colorectal cancer
Descriptive analysis will be done using following the questionnaire: Fear of cancer recurrence - SF
Measured: 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
Secondary outcomes (1)
Risk factors associated with developing psychological distress
Univariate and multivariate regression analysis will be performed to identify potential risk
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start25 Jan 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Skane University Hospital
- Responsible party
- Sponsor
- Investigators
- Rogini Balachandran, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956107
- Sponsor's protocol ID
- Preserve
- Acronym
- PRESERVE
- Status last verified
- Nov 2022
- First submitted
- 28 Jun 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balachandran R, Thaysen HV, Christensen P, Zachariae R, Iversen LH. Biopsychosocial Late Effects After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Metastases from Colorectal and Appendiceal Cancer: A National Prospective Cohort Study. Ann Surg Oncol. 2024 Mar;31(3):1959-1969. doi: 10.1245/s10434-023-14618-6. Epub 2023 Dec 21.
PubMed 38127212
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Distress in Colorectal Cancer Patients Following Surgery With Either HIPEC or Pelvic Exenteration
- ClinicalTrials.gov ID
- NCT04956107
- Acronym / sponsor ID
- PRESERVE / Preserve
- Conditions
- Colo-rectal Cancer
- Keywords
- cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, pelvic exenteration, adverse effects, psychological distress, anxiety, depression, fear of cancer recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Skane University Hospital
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIPEC cohort | – | –Patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer with peritoneal metastases |
| PE cohort | – | –Patients undergoing pelvic exenteration (PE) for colorectal cancer with involvement of the urinary bladder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will prospectively include patients who have undergone surgery at Aarhus University Hospital, Karolinska University Hospital, Stockholm, and Skåne University Hospital, Malmö. Inclusion in Denmark will start February 2021 and in Sweden Summer 2021. Inclusion period is 15 months. The HIPEC cohort will be established as a cross-sectional study. For newly operated patients, inclusion will happen shortly after surgery with prospective questionnaire follow-ups at 3, 6 and 12 months after inclusion. For patients who have undergone CRS+HIPEC more than 3 months ago, initial inclusion can take place at 6, 12, 18, 24, 36, 48 and 60 months after surgery. Patients in the PE cohort will be included shortly after surgery with follow-up at 3 months, 6 months and 12 months after surgery.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of depression after PE or CRS+HIPEC for colorectal cancer
Time frame: 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 anxiety after PE or CRS+HIPEC for colorectal cancer
Time frame: 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 cognitive dysfunction after PE or CRS+HIPEC for colorectal cancer
Time frame: 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 sleeping issues after PE or CRS+HIPEC for colorectal cancer
Time frame: 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 fatigue after PE or CRS+HIPEC for colorectal cancer
Time frame: 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)
Development of ´fear of cancer recurrence' after PE or CRS+HIPEC for colorectal cancer
Time frame: 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
1 secondary outcome
Risk factors associated with developing psychological distress
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 38127212Balachandran R, Thaysen HV, Christensen P, Zachariae R, Iversen LH. Biopsychosocial Late Effects After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Metastases from Colorectal and Appendiceal Cancer: A National Prospective Cohort Study. Ann Surg Oncol. 2024 Mar;31(3):1959-1969. doi: 10.1245/s10434-023-14618-6. Epub 2023 Dec 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene H Iversen, Professor contact
Rogini Balachandran, MD principal investigator
Aarhus University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by University of Aarhus at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rogini Balachandran, MD (+4542400620, rogbal@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of depression after PE or CRS+HIPEC for colorectal cancer (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04956107, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.