A randomised controlled trial to improve the resilience of oesophageal cancer survivors in rural China: A study protocol

Abstract

AbstractAimTo design a protocol based on the experiences of long‐term survivors to facilitate resilience for oesophageal cancer patients in rural China.BackgroundAccording to the latest Global Cancer Statistics Report, 604,000 new cases of oesophageal cancer were reported, of which over 60% of the disease burden is distributed in China. The incidence of oesophageal cancer in rural China (15.95/100,000) is twice as high as those in urban areas (7.59/100,000). To be sure, resilience can help patients better adapt to post‐cancer life. But universal interventions involving improving the resilience of oesophageal cancer patients have much less been explored, especially for rural patients.MethodsThe two‐arm, parallel design, non‐blinded, randomised controlled trial will be implemented in 86 adults diagnosed with oesophageal cancer and will be randomly assigned to the control group or the intervention group via the blocked randomisation. The intervention group will undergo an intervention with one‐on‐one guidance from a nurse while viewing a CD of the experiences of long‐term survivors with oesophageal cancer in rural areas. Every 2 weeks, a theme session will be introduced, and the entire intervention will continue for 12 weeks. Psychosocial variables (resilience, self‐efficacy, coping mode and family support) will be surveyed at baseline, post‐intervention and 3 months after the intervention. The paper complies with the Standard Protocol Items: Recommendations for Intervention Trials 2013 and Consolidated Standards of Reporting Trials guidelines for study protocols adapted for designing and reporting parallel group randomised trials.ConclusionThe intervention programme transitions from hospitalisation to discharge, which includes one‐on‐one interventions by medical personnel and a portable CD describing the experiences of long‐term survivors with rural oesophageal cancer. Once the intervention's effectiveness is proven, this protocol will provide psychological support for massive oesophageal cancer patients.Relevance to clinical practiceThe intervention programme may be used as an auxiliary therapy to promote patients' postoperative psychological rehabilitation. This programme has the advantages of being cost‐effective, flexible, accessible, and convenient and can be implemented without the limitation of time, place and clinical medical staff.Trial registrationThe Chinese Clinical Trial Registration number is ChiCTR2100050047. Registered on 16 August 2021.