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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| Skane University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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 | 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) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Risk factors associated with developing psychological distress | Univariate and multivariate regression analysis will be performed to identify potential risk | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rogini Balachandran, MD | Contact | +4542400620 | rogbal@rm.dk | |
| Lene H Iversen, Professor | Contact | d268143@dadlnet.dk |
| Name | Affiliation | Role |
|---|---|---|
| Rogini Balachandran, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38127212 | Derived | 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. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 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 | 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 |
| Department of Surgery, Karolinska University Hospital | Not yet recruiting | Solna | Stockholm County | 17164 | Sweden |
|
| Department of Surgery, Skånes University Hospital, Malmö | Not yet recruiting | Malmö | 21428 | Sweden |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |