Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the Convalescence Symptom Assessment Scale for EsophageCtomy patients (CSAS_EC)
研究概览
简要总结
Esophageal cancer imposes a significant burden in China, accounting for over 60% of the global disease burden. While surgery remains a common and highly effective treatment for esophageal cancer, patients often experience multiple physical and psychological symptoms postoperatively, severely affecting their recovery outcomes and quality of life. Although existing exercise or psychological intervention programs have shown some effectiveness, issues such as relatively singular intervention content, imprecise intervention timing, and vague intervention details persist.
This project, based on previous research foundations (including the development of symptom measurement tools and the identification of key recovery periods), is guided by symptom management theory and knowledge translation models. Taking a perspective of the synergistic impact of physical and psychological symptoms, the study focuses on patients undergoing esophageal cancer surgery. Initially, evidence-based literature review, focus group interviews, and expert consultations were conducted to develop a combined exercise and psychological intervention program, integrating subjective (CSCA_EC) and objective (6MWT) measurement indicators, named "Recovery For EC." Subsequently, the program was preliminarily applied in clinical settings using a mixed-methods approach, combining quantitative quasi-experimental design (108 cases) and qualitative interviews to assess its acceptability. The final clinical trial version of the Recovery For EC program was developed to provide patients with a tool for self-monitoring recovery outcomes and offer clinical healthcare professionals guidance for implementing precise and personalized rehabilitation management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of esophageal cancer by pathological biopsy.
- •Undergoing surgical treatment.
- •Age ≥ 18 years old.
- •The patient is able to communicate effectively in language.
- •The patient is fully aware of their condition and willingly participates in the investigation.
排除标准
- •Patients with consciousness disorders.
- •Patients with severe physical illnesses who are unable to cooperate with the investigation.
- •Participation in other studies.
研究组 & 干预措施
Exercise training
Implementing only exercise intervention for participants, including aerobic exercise, breathing exercises, resistance exercises, with specific exercise regimes tailored to the participants' physical conditions.
干预措施: Exercise and Psychological Intervention (Behavioral)
Mindfulness-Based Stress Reduction Therapy
Implementing only mindfulness-based stress reduction therapy as the main psychological intervention for participants, and dynamically adjusting based on the participants' psychological states.
干预措施: Exercise and Psychological Intervention (Behavioral)
Exercise combined with Mindfulness-Based Stress Reduction Therapy
Implementing intervention combining exercise with mindfulness-based stress reduction therapy for participants, and dynamically adjusting based on the participants' physical and mental recovery status.
干预措施: Exercise and Psychological Intervention (Behavioral)
Routine care
Implementing only the department's routine care for esophageal cancer surgical patients.
结局指标
主要结局
the Convalescence Symptom Assessment Scale for EsophageCtomy patients (CSAS_EC)
时间窗: Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.
The Convalescence Symptom Assessment Scale for EsophageCtomy patients (CSAS\_EC) is an instrument developed by our research team based on patient self-reported outcomes, designed to assess the symptomatology and functional level during the recovery period of esophagectomy patients. This CSAS\_EC has been developed and refined into an 11-point scale with 28 items, encompassing four dimensions (early recovery symptoms, late recovery symptoms, persistent symptoms, and psychosocial symptoms). The CSAS\_EC scores range from 0 to 280, with higher scores indicating more severe postoperative symptoms in esophageal cancer patients.
次要结局
- 6-Minute Walk Test(Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.)
- Hospital Anxiety and Depression Scale (HADS)(Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.)
- Postoperative Complications(Postoperative day 7)
研究者
Mengmeng Yuan
Research Assistant
Anhui Medical University
