School of Nursing, Anhui Medical University, Hefei, China.
Department of Thoracic Surgery, the First Affiliated Hospital of University of Science and Technology of China, Hefei, China.
J Clin Nurs. 2023 Jul;32(13-14):4116-4127. doi: 10.1111/jocn.16638. Epub 2023 Mar 9.
To design a protocol based on the experiences of long-term survivors to facilitate resilience for oesophageal cancer patients in rural China.
According 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.
The 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.
The 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.
The 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.
The Chinese Clinical Trial Registration number is ChiCTR2100050047. Registered on 16 August 2021.
基于长期生存者的经验设计方案，以提高中国农村地区食管癌患者的韧性。
根据最新的《全球癌症统计报告》，全球新报告食管癌病例 60.4 万例，其中超过 60%的疾病负担分布在中国。中国农村地区食管癌发病率（15.95/10 万）是城市地区（7.59/10 万）的两倍。可以肯定的是，韧性可以帮助患者更好地适应癌症后的生活。但是，很少有研究探索涉及提高食管癌患者韧性的普遍干预措施，尤其是针对农村患者。
该两臂、平行设计、非盲、随机对照试验将在 86 名被诊断为食管癌的成年人中实施，并通过区组随机化分配到对照组或干预组。干预组将在护士的一对一指导下观看一张农村地区食管癌长期生存者经历的 CD。每两周引入一个主题，整个干预将持续 12 周。在基线、干预后和干预后 3 个月时，将调查心理社会变量（韧性、自我效能感、应对模式和家庭支持）。该论文符合 2013 年干预试验标准项目建议和适合设计和报告平行组随机试验的临床试验报告标准指南。
干预方案从住院转为出院，包括医疗人员的一对一干预和一张描述农村食管癌长期生存者经历的便携式 CD。一旦证明干预的有效性，该方案将为大量食管癌患者提供心理支持。
干预方案可作为辅助治疗，促进患者术后心理康复。该方案具有经济有效、灵活、便捷的优势，无需时间、地点和临床医务人员的限制。
中国临床试验注册中心注册号 ChiCTR2100050047。注册于 2021 年 8 月 16 日。
