protocolSection identificationModule nctId: NCT06366685, orgStudyIdInfo id: YJS20230170, briefTitle: Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy, acronym: Recovery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Mengmeng Yuan, class: OTHER, collaborators name: Anhui Medical University, descriptionModule briefSummary: 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., conditionsModule conditions: Esophageal Cancer, conditions: Exercise Training, conditions: Psychotherapy, conditions: Rehabilitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Exercise and Psychological Intervention, outcomesModule primaryOutcomes measure: the Convalescence Symptom Assessment Scale for EsophageCtomy patients (CSAS_EC), secondaryOutcomes measure: 6-Minute Walk Test, secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Postoperative Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Medical University, city: Hefei, state: Anhui, zip: 234000, country: China, contacts name: Mengmeng Yuan, Graduate, role: CONTACT, phone: 18205575607, email: 2510950595@qq.com, contacts name: Shaoxue Li, Graduate, role: CONTACT, phone: 18712335223, email: 2581558674@qq.com, contacts name: Shuwen Li, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False