Abstract
BACKGROUND: As the population of colorectal cancer (CRC) survivors continues to grow, the demand for effective, evidence-based post-treatment strategies becomes increasingly urgent. Despite robust evidence linking lifestyle factors to cancer outcomes, there remains no established consensus on the optimal nutritional and physical activity (PA) guidelines for disease-free CRC survivors. AIM: To demonstrate that structured lifestyle interventions, specifically tailored dietary and PA programs, can significantly improve behavioral targets as well as disease-free and overall survival (OS). METHODS: We designed a 2 × 2 factorial phase II randomized controlled trial to compare the effects of dietary and PA interventions with standard care. RESULTS: A total of 300 CRC survivors in complete remission will be recruited from oncology centers in Misurata and Zliten (Libya) and the Habib Bourguiba University Hospital (Tunisia). Participants will be randomized into four groups: Combined intervention, diet-only, PA-only, or usual care. They will be followed for 24 months, with outcomes including disease-free survival, OS, and quality of life. Ethical approval has been obtained (Sfax ID: 61/24; Misurata ID: 04/2023), and the trial is registered at ClinicalTrials.gov (NCT06194786). CONCLUSION: This study will provide crucial region-specific evidence on the feasibility and effectiveness of lifestyle interventions in CRC survivorship care. By evaluating the role of a high-fiber, low-red meat diet and structured PA, we aim to demonstrate the potential of these behaviors to improve survival outcomes and support their integration into future clinical practice guidelines.