Quality Of Life In Colorectal Cancer Survivors

February 16, 2026 updated by: Institute of Oncology Ljubljana
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 6, 12, and 24 months after oncological treatment
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)
Time Frame: 6, 12, and 24 months after oncological treatment
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

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Oncology Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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