Pilot Study of Individualized Comprehensive Rehabilitation in Patients With Colorectal Cancer

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.

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