An interventional study of Individualized Comprehensive Rehabilitation in Colon Cancer and Rectal Cancer, sponsored by Institute of Oncology Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Institute of Oncology Ljubljana · Not applicable, Interventional, and Supportive care
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.
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 150 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Institute of Oncology Ljubljana is the lead sponsor of 88 studies on the registry; 28 are open to participants now.
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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
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
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.
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.
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.
Time frame: Baseline (at diagnosis), 6 months after diagnosis, and 12 months after diagnosis
Change in Patient-Reported Problems Assessed by Triage Questionnaire
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.
Time frame: Baseline (at diagnosis), 6 months after diagnosis, and 12 months after diagnosis
Duration of Sick Leave (Absenteeism)
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.
Time frame: Up to 12 months after diagnosis
Disability Retirement Rate
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.
Time frame: Through study completion (up to 24 months)
Plan to share: No
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Institute of Oncology Ljubljana