Pilot Study of Individualized Comprehensive Rehabilitation in Patients With Colorectal Cancer

February 17, 2026 updated by: Institute of Oncology Ljubljana

Pilot Research on Individualized Comprehensive Rehabilitation of Patients With Colorectal Cancer 2022-2024

This study is a pilot interventional study evaluating an individualized, comprehensive rehabilitation approach for patients with colorectal cancer in Slovenia. Patients treated for colorectal cancer often experience long-term physical, psychological, and social consequences of the disease and its treatment. Currently, rehabilitation services are not provided in a coordinated or systematic way. The aim of this study is to identify patients' rehabilitation needs and to assess the feasibility and potential benefits of a coordinated multidisciplinary rehabilitation pathway. Participants are guided through an individualized rehabilitation pathway and referred to appropriate healthcare professionals (e.g., physiotherapists, dietitians, psychologists, physicians, and other specialists) according to their needs. No experimental medications or devices are used. Results will support the development of structured comprehensive rehabilitation programs for colorectal cancer patients at the national level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study evaluates the feasibility and potential benefits of an individualized, coordinated comprehensive rehabilitation pathway for patients with colorectal cancer in Slovenia. Patients with colorectal cancer frequently experience long-term physical symptoms, psychological distress, and social or occupational difficulties as a consequence of the disease and its oncological treatment. Despite improved survival rates, comprehensive rehabilitation is not systematically implemented in Slovenia, and supportive services are typically delivered in a fragmented and non-coordinated manner.

The study is designed as a prospective, non-randomized, controlled pilot interventional study conducted at the Institute of Oncology Ljubljana. A total of 150 adult patients with colorectal cancer will be included and assigned to either a control group (usual care) or an intervention group (coordinated individualized comprehensive rehabilitation), with 75 participants in each group.

Participants in both groups complete standardized patient-reported outcome measures assessing health-related quality of life (EORTC QLQ-C30 and EORTC QLQ-CR29) and a structured triage questionnaire assessing patient-reported problems across multiple domains. Assessments are performed at baseline (at diagnosis), and at follow-up visits approximately 6 months and 12 months after diagnosis.

The control group receives standard oncological follow-up care. Any referrals to rehabilitation services are provided according to routine clinical practice at the discretion of the treating oncologist.

Participants in the intervention group are managed through a coordinated rehabilitation pathway. Based on questionnaire results and clinical evaluation, patients are assessed by a rehabilitation coordinator, and their needs are reviewed by a multidisciplinary team. Participants are referred to appropriate rehabilitation services according to predefined rehabilitation recommendations and available provider networks. Rehabilitation may include physical rehabilitation and exercise counseling, nutritional counseling, psychological support, and other supportive care interventions tailored to individual needs.

The primary objective of the study is to assess changes in health-related quality of life over time and to evaluate whether a coordinated rehabilitation approach is feasible and potentially beneficial for patients with colorectal cancer. Secondary objectives include evaluation of patient-reported problems, as well as work-related outcomes such as duration of sick leave and disability retirement rates.

The results of this pilot study will support future planning and implementation of structured comprehensive rehabilitation programs for colorectal cancer patients at the national level.

Study Type

Interventional

Enrollment (Actual)

150

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 Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana

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:

Adult patients (≥18 years) with histologically confirmed colorectal cancer

Patients who have completed primary oncological treatment (surgery ± systemic therapy and/or radiotherapy)

Patients eligible for and willing to participate in an individualized comprehensive rehabilitation program

Ability to understand the study procedures and provide written informed consent

Exclusion Criteria:

Severe cognitive impairment or psychiatric condition preventing participation

Uncontrolled comorbidities that contraindicate participation in rehabilitation (e.g. severe cardiovascular instability)

Inability to participate in follow-up assessments

Concurrent participation in another interventional clinical study that could interfere with study outcomes

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individualized Comprehensive Rehabilitation
Participants receive an individualized, multidisciplinary comprehensive rehabilitation program following treatment for colorectal cancer. The program includes physical, nutritional, psychological, and supportive components tailored to individual needs.
Behavioral: Individualized Comprehensive Rehabilitation
A personalized, multidisciplinary rehabilitation intervention tailored to individual patient needs, including supervised physical exercise, nutritional counseling, psychological support, and education aimed at improving functional capacity, recovery, and quality of life in patients with colorectal cancer.
No Intervention: Control: Usual Care (Standard Oncology Follow-up)
Participants receive standard oncological follow-up care after diagnosis and treatment of colorectal cancer. Participants complete study questionnaires at baseline, 6 months, and 12 months. Any referrals to rehabilitation services are provided according to routine clinical practice at the discretion of the treating oncologist. No coordinated rehabilitation pathway is provided as part of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Health-Related Quality of Life (EORTC QLQ-C30 and EORTC QLQ-CR29 Scores)
Time Frame: Baseline (at diagnosis), 6 months after diagnosis, and 12 months after diagnosis
Health-related quality of life (HRQoL) is assessed using the validated European Organisation for Research and Treatment of Cancer questionnaires: EORTC QLQ-C30 (core cancer quality of life questionnaire) and EORTC QLQ-CR29 (colorectal cancer-specific module). Questionnaire responses are scored according to EORTC scoring manuals and transformed to a 0-100 scale. Changes in HRQoL domains (global health status, functional scales, and symptom scales) are evaluated over time. Higher scores on functional scales and global health status represent better quality of life, while higher scores on symptom scales represent worse symptom burden.
Baseline (at diagnosis), 6 months after diagnosis, and 12 months after diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient-Reported Problems Assessed by Triage Questionnaire
Time Frame: Baseline (at diagnosis), 6 months after diagnosis, and 12 months after diagnosis
Patient-reported problems are assessed using a structured triage questionnaire covering 17 domains of physical, psychological, social, and functional difficulties. Changes in the number and severity of reported problems over time are evaluated to assess rehabilitation needs and response to the rehabilitation pathway.
Baseline (at diagnosis), 6 months after diagnosis, and 12 months after diagnosis
Duration of Sick Leave (Absenteeism)
Time Frame: Up to 12 months after diagnosis
Work absenteeism is assessed as the total duration of sick leave during follow-up. The duration of sick leave is compared between the intervention group and the control group to evaluate the impact of coordinated comprehensive rehabilitation on return-to-work outcomes.
Up to 12 months after diagnosis
Disability Retirement Rate
Time Frame: Through study completion (up to 24 months)
Disability retirement is assessed as the proportion of participants who apply for or receive disability retirement (partial or full) during follow-up. Rates are compared between the intervention group and the control group.
Through study completion (up to 24 months)

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)

October 1, 2022

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 17, 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 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OI_PILKO-2022

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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