Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy
NCT ID: NCT06366685
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-05-01
2025-02-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
Exercise and Psychological Intervention
To address the symptoms and severity experienced by esophageal cancer patients after surgery, providing them with exercise or psychological interventions to improve their rehabilitation outcomes.
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.
Exercise and Psychological Intervention
To address the symptoms and severity experienced by esophageal cancer patients after surgery, providing them with exercise or psychological interventions to improve their rehabilitation outcomes.
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.
Exercise and Psychological Intervention
To address the symptoms and severity experienced by esophageal cancer patients after surgery, providing them with exercise or psychological interventions to improve their rehabilitation outcomes.
Routine care
Implementing only the department's routine care for esophageal cancer surgical patients.
No interventions assigned to this group
Interventions
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Exercise and Psychological Intervention
To address the symptoms and severity experienced by esophageal cancer patients after surgery, providing them with exercise or psychological interventions to improve their rehabilitation outcomes.
Eligibility Criteria
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Inclusion Criteria
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
2. Patients with severe physical illnesses who are unable to cooperate with the investigation.
3. Participation in other studies.
18 Years
80 Years
ALL
No
Sponsors
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Anhui Medical University
OTHER
Mengmeng Yuan
OTHER
Responsible Party
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Mengmeng Yuan
Research Assistant
Locations
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Anhui Medical University
Hefei, Anhui, China
Countries
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Facility Contacts
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References
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Sung 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.
Liu 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.
Ma 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.
Liu 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.
Gupta 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.
Hellstadius 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.
Ohkura 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.
Liu Y, Pettersson E, Schandl A, Markar S, Johar A, Lagergren P. Psychological distress after esophageal cancer surgery and the predictive effect of dispositional optimism: a nationwide population-based longitudinal study. Support Care Cancer. 2022 Feb;30(2):1315-1322. doi: 10.1007/s00520-021-06517-x. Epub 2021 Sep 4.
Johns SA, Von Ah D, Brown LF, Beck-Coon K, Talib TL, Alyea JM, Monahan PO, Tong Y, Wilhelm L, Giesler RB. Randomized controlled pilot trial of mindfulness-based stress reduction for breast and colorectal cancer survivors: effects on cancer-related cognitive impairment. J Cancer Surviv. 2016 Jun;10(3):437-48. doi: 10.1007/s11764-015-0494-3. Epub 2015 Nov 19.
Lee JY, Park HY, Jung D, Moon M, Keam B, Hahm BJ. Effect of brief psychoeducation using a tablet PC on distress and quality of life in cancer patients undergoing chemotherapy: a pilot study. Psychooncology. 2014 Aug;23(8):928-35. doi: 10.1002/pon.3503. Epub 2014 Feb 18.
Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.
Anandavadivelan P, Malberg K, Vikstrom K, Nielsen S, Holdar U, Johar A, Lagergren P. Home-based physical activity after treatment for esophageal cancer-A randomized controlled trial. Cancer Med. 2023 Feb;12(3):3477-3487. doi: 10.1002/cam4.5131. Epub 2022 Aug 18.
van Vulpen JK, Hiensch AE, van Hillegersberg R, Ruurda JP, Backx FJG, Nieuwenhuijzen GAP, Kouwenhoven EA, Groenendijk RPR, van der Peet DL, Hazebroek EJ, Rosman C, Wijnhoven BPL, van Berge Henegouwen MI, van Laarhoven HWM, Siersema PD, May AM. Supervised exercise after oesophageal cancer surgery: the PERFECT multicentre randomized clinical trial. Br J Surg. 2021 Jul 23;108(7):786-796. doi: 10.1093/bjs/znab078.
Hofmann SG, Gomez AF. Mindfulness-Based Interventions for Anxiety and Depression. Psychiatr Clin North Am. 2017 Dec;40(4):739-749. doi: 10.1016/j.psc.2017.08.008. Epub 2017 Sep 18.
Chinh K, Mosher CE, Brown LF, Beck-Coon KA, Kroenke K, Johns SA. Psychological Processes and Symptom Outcomes in Mindfulness-Based Stress Reduction for Cancer Survivors: A Pilot Study. Mindfulness (N Y). 2020 Apr;11(4):905-916. doi: 10.1007/s12671-019-01299-0. Epub 2020 Jan 14.
Victorson D, Murphy K, Benedict C, Horowitz B, Maletich C, Cordero E, Salsman JM, Smith K, Sanford S. A randomized pilot study of mindfulness-based stress reduction in a young adult cancer sample: Feasibility, acceptability, and changes in patient reported outcomes. Psychooncology. 2020 May;29(5):841-850. doi: 10.1002/pon.5355. Epub 2020 Feb 25.
Other Identifiers
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YJS20230170
Identifier Type: -
Identifier Source: org_study_id
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