Quality Of Life In Colorectal Cancer Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Rectal Cancer; Colon Cancer
• Intervention / Treatment: Other: Quality of Life Assessment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 368
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klavdija Korošec; Phone Number: +386 31630065; Email: kkorosec@onko-i.si
• Study Contact Backup: Name: Neža Gros; Email: ngros@onko-i.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Institute of Oncology Ljubljana
    • Contact: Klavdija Korošec; Phone Number: +386 31630065; Email: kkorosec@onko-i.si
    • Contact: Neža Gros; Email: ngros@onko-i.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with colorectal cancer (colon or rectal cancer)
• Age 25 to 65 years
• First oncological treatment performed at the Institute of Oncology Ljubljana
• Working-capable patients
• Ability to complete questionnaires
• Ability to provide written informed consent

Exclusion Criteria:

• Age < 25 years or > 65 years
• Patients unable to complete questionnaires
• Patients unable to participate in follow-up assessments
• Patients who do not provide written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quality of Life Assessment Group; 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.	Other: Quality of Life Assessment; Quality of life assessment using questionnaires at 6, 12, and 24 months after oncological treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Cancer Survivors; Late Adverse Effects
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Rectal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: OIL_CCS_2023; ERIDNPVO-0051/2023 (Other Identifier: Institute of Oncology Ljubljana); 0120-192/2023/6 (Other Identifier: Republic of Slovenia National Medical Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No