BACKGROUNDAs the population of colorectal cancer(CRC)survivors continues to grow,thedemand for effective,evidence-based post-treatment strategies becomes increasinglyurgent.Despite robust evidence linking lifestyle fa...BACKGROUNDAs the population of colorectal cancer(CRC)survivors continues to grow,thedemand for effective,evidence-based post-treatment strategies becomes increasinglyurgent.Despite robust evidence linking lifestyle factors to canceroutcomes,there remains no established consensus on the optimal nutritional andphysical activity(PA)guidelines for disease-free CRC survivors.AIMTo demonstrate that structured lifestyle interventions,specifically tailored dietaryand PA programs,can significantly improve behavioral targets as well as diseasefreeand overall survival(OS).METHODSWe designed a 2×2 factorial phase II randomized controlled trial to compare the effects of dietary and PA interventions with standard care.RESULTSA 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 outcomesincluding 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).CONCLUSIONThis study will provide crucial region-specific evidence on the feasibility and effectiveness of lifestyle interventionsin CRC survivorship care.By evaluating the role of a high-fiber,low-red meat diet and structured PA,we aim todemonstrate the potential of these behaviors to improve survival outcomes and support their integration intofuture clinical practice guidelines.展开更多
文摘BACKGROUNDAs the population of colorectal cancer(CRC)survivors continues to grow,thedemand for effective,evidence-based post-treatment strategies becomes increasinglyurgent.Despite robust evidence linking lifestyle factors to canceroutcomes,there remains no established consensus on the optimal nutritional andphysical activity(PA)guidelines for disease-free CRC survivors.AIMTo demonstrate that structured lifestyle interventions,specifically tailored dietaryand PA programs,can significantly improve behavioral targets as well as diseasefreeand overall survival(OS).METHODSWe designed a 2×2 factorial phase II randomized controlled trial to compare the effects of dietary and PA interventions with standard care.RESULTSA 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 outcomesincluding 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).CONCLUSIONThis study will provide crucial region-specific evidence on the feasibility and effectiveness of lifestyle interventionsin CRC survivorship care.By evaluating the role of a high-fiber,low-red meat diet and structured PA,we aim todemonstrate the potential of these behaviors to improve survival outcomes and support their integration intofuture clinical practice guidelines.
