NCT07428239

Pilot Study of Individualized Comprehensive Rehabilitation in Patients With Colorectal Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Colon Cancer
• Rectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Slovenia