Pilot Study of Individualized Comprehensive Rehabilitation in Patients With Colorectal Cancer

NCT07428239 | Completed

• 1 other identifier: OI_PILKO-2022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer; Rectal Cancer

Keywords

Comprehensive rehabilitation; Cancer rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Health-Related Quality of Life (EORTC QLQ-C30 and EORTC QLQ-CR29 Scores)

  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 Outcomes (3)

• Change in Patient-Reported Problems Assessed by Triage Questionnaire

  Baseline (at diagnosis), 6 months after diagnosis, and 12 months after diagnosis

• Duration of Sick Leave (Absenteeism)

  Up to 12 months after diagnosis

• Disability Retirement Rate

  Through study completion (up to 24 months)

Study Arms (2)

Individualized Comprehensive Rehabilitation

EXPERIMENTAL

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

Control: Usual Care (Standard Oncology Follow-up)

NO INTERVENTION

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.

Interventions

Individualized Comprehensive Rehabilitation BEHAVIORAL

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.

Individualized Comprehensive Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants and investigators are aware of group assignment. Outcomes are assessed using standardized patient-reported questionnaires at baseline, 6 months, and 12 months after diagnosis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to either an intervention group receiving coordinated individualized comprehensive rehabilitation or a control group receiving usual care (standard oncology follow-up). Outcomes are assessed using standardized questionnaires at baseline (at diagnosis), 6 months, and 12 months after diagnosis to evaluate feasibility and changes in quality of life and patient-reported problems.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 23, 2026
• Study Start: October 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)