NCT07427901

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
20mo left

Started May 2023

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
May 2023Dec 2027

Study Start

First participant enrolled

May 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 5, 2026

Last Update Submit

February 16, 2026

Conditions

Keywords

Quality of LifeCancer SurvivorsLate Adverse Effects

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Colorectal Cancer-Specific Quality of Life (EORTC QLQ-CR29)

    6, 12, and 24 months after oncological treatment

Study Arms (1)

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.

Other: Quality of Life Assessment

Interventions

Quality of life assessment using questionnaires at 6, 12, and 24 months after oncological treatment.

Quality of Life Assessment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Klavdija Korošec

CONTACT

Neža Gros

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single-group study evaluating quality of life and late adverse effects in colorectal cancer patients at 6, 12, and 24 months after oncological treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 23, 2026

Study Start

May 1, 2023

Primary Completion

January 1, 2024

Study Completion (Estimated)

December 31, 2027

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations