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| ID | Type | Description | Link |
|---|---|---|---|
| ERIDNPVO-0051/2023 | Other Identifier | Institute of Oncology Ljubljana | |
| 0120-192/2023/6 | Other Identifier | Republic of Slovenia National Medical Ethics Committee |
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The purpose of this study is to identify late adverse effects in colorectal cancer patients that may influence quality of life at 6, 12, and 24 months after oncological treatment. The study aims to assess quality of life in colorectal cancer survivors in relation to psycho-physical-social well-being at different time points and to evaluate the prevalence of late adverse effects and their association with diagnosis and specific oncological treatment.
The purpose of this study is to identify late adverse effects in patients with colorectal cancer that may influence quality of life at 6, 12, and 24 months after oncological treatment. The study will assess quality of life in colorectal cancer patients in relation to psycho-physical-social well-being at different time points. In addition, the study will identify and evaluate the prevalence of late adverse effects and analyze their association with diagnosis and specific oncological treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quality of Life Assessment Group | Experimental | Participants with colorectal cancer after oncological treatment will complete quality of life assessments at 6, 12, and 24 months to identify late adverse effects and evaluate psycho-physical-social well-being. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of Life Assessment | Other | Quality of life assessment using questionnaires at 6, 12, and 24 months after oncological treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Score (EORTC QLQ-C30 Global Health Status/QoL Scale) | Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), specifically the Global Health Status/Quality of Life scale (items 29 and 30). Scores will be linearly transformed to a 0 to 100 scale. Higher scores indicate better quality of life. | 6, 12, and 24 months after oncological treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal Cancer-Specific Quality of Life (EORTC QLQ-CR29) | Colorectal cancer-specific quality of life will be assessed using the EORTC QLQ-CR29 questionnaire. Scores will be linearly transformed to a 0 to 100 scale. Higher scores indicate better functioning for functional scales and worse symptoms for symptom scales. | 6, 12, and 24 months after oncological treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Klavdija Korošec | Contact | +386 31630065 | kkorosec@onko-i.si | |
| Neža Gros | Contact | ngros@onko-i.si |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology Ljubljana | Recruiting | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Single-group study evaluating quality of life and late adverse effects in colorectal cancer patients at 6, 12, and 24 months after oncological treatment.
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |