Clinical trial · Interventional
Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Exercise Training | — | UNRESOLVED | — |
| Psychotherapy | — | UNRESOLVED | — |
| Rehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise and Psychological Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Exercise training
- description
- Implementing only exercise intervention for participants, including aerobic exercise, breathing exercises, resistance exercises, with specific exercise regimes tailored to the participants' physical conditions.
- interventionNames
- Behavioral: Exercise and Psychological Intervention
- type
- EXPERIMENTAL
- label
- Mindfulness-Based Stress Reduction Therapy
- description
- Implementing only mindfulness-based stress reduction therapy as the main psychological intervention for participants, and dynamically adjusting based on the participants' psychological states.
- interventionNames
- Behavioral: Exercise and Psychological Intervention
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed diagnosis of esophageal cancer by pathological biopsy. 2. Undergoing surgical treatment. 3. Age ≥ 18 years old. 4. The patient is able to communicate effectively in language. 5. The patient is fully aware of their condition and willingly participates in the investigation. Exclusion Criteria: 1. Patients with consciousness disorders. 2. Patients with severe physical illnesses who are unable to cooperate with the investigation. 3. Participation in other studies.
References
Publications (16)
- RESULTSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- RESULTLiu CQ, Ma YL, Qin Q, Wang PH, Luo Y, Xu PF, Cui Y. Epidemiology of esophageal cancer in 2020 and projections to 2030 and 2040. Thorac Cancer. 2023 Jan;14(1):3-11. doi: 10.1111/1759-7714.14745. Epub 2022 Dec 8. PMID 36482832
- RESULTMa X, Ge H, Zhang X, Li S. Survival experience of patients undergoing oesophagectomy during the recovery period: A meta-synthesis of qualitative studies. J Clin Nurs. 2023 Sep;32(17-18):5579-5595. doi: 10.1111/jocn.16648. Epub 2023 Feb 17. PMID 36802111
- RESULTLiu L, Liu QW, Wu XD, Liu SY, Cao HJ, Hong YT, Qin HY. Follow-up study on symptom distress in esophageal cancer patients undergoing repeated dilation. World J Clin Cases. 2020 Aug 26;8(16):3503-3514. doi: 10.12998/wjcc.v8.i16.3503. PMID 32913857
- RESULTGupta V, Allen-Ayodabo C, Davis L, Zhao H, Hallet J, Mahar AL, Ringash J, Kidane B, Darling G, Coburn NG. Patient-Reported Symptoms for Esophageal Cancer Patients Undergoing Curative Intent Treatment. Ann Thorac Surg. 2020 Feb;109(2):367-374. doi: 10.1016/j.athoracsur.2019.08.030. Epub 2019 Sep 21. PMID 31550465
- RESULTHellstadius Y, Lagergren P, Lagergren J, Johar A, Hultman CM, Wikman A. Aspects of emotional functioning following oesophageal cancer surgery in a population-based cohort study. Psychooncology. 2015 Jan;24(1):47-53. doi: 10.1002/pon.3583. Epub 2014 Jun 3. PMID 24895142
- RESULTOhkura Y, Ichikura K, Shindoh J, Ueno M, Udagawa H, Matsushima E. Association between psychological distress of each points of the treatment of esophageal cancer and stress coping strategy. BMC Psychol. 2022 Sep 6;10(1):214. doi: 10.1186/s40359-022-00914-5.