Esophageal CancerRecoveryNCT06366685
Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy
A study testing Exercise and Psychological Intervention in people with Esophageal Cancer and Exercise Training, run by Mengmeng Yuan at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer, Exercise Training, Psychotherapy
- What is being tested?
- Exercise and Psychological Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with consciousness disorders.
- Patients with severe physical illnesses who are unable to cooperate with the investigation.
- Participation in other studies.
Trial locations and contacts
1 site in 1 country.
China1 site
Anhui Medical University
Hefei, Anhui, 234000
Mengmeng Yuan, Graduate, 18205575607, 2510950595@qq.com
Shaoxue Li, Graduate, 18712335223, 2581558674@qq.com
About this study
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
- Esophageal Cancer, Exercise Training, Psychotherapy, Rehabilitation
- Being tested
- Exercise and Psychological Intervention
- Keywords
- Esophageal cancer, Esophagectomy, Rehabilitation
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and Psychological InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | Implementing only exercise intervention for participants, including aerobic exercise, breathing exercises, resistance exercises, with specific exercise regimes tailored to the participants' physical conditions. Receives: Behavioral: Exercise and Psychological Intervention |
| Mindfulness-Based Stress Reduction Therapy | Experimental | Implementing only mindfulness-based stress reduction therapy as the main psychological intervention for participants, and dynamically adjusting based on the participants' psychological states. Receives: Behavioral: Exercise and Psychological Intervention |
| Exercise combined with Mindfulness-Based Stress Reduction Therapy | Experimental | Implementing intervention combining exercise with mindfulness-based stress reduction therapy for participants, and dynamically adjusting based on the participants' physical and mental recovery status. Receives: Behavioral: Exercise and Psychological Intervention |
| Routine care | No intervention | Implementing only the department's routine care for esophageal cancer surgical patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Convalescence Symptom Assessment Scale for EsophageCtomy patients (CSAS_EC)
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.
Measured: Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.
Secondary outcomes (3)
6-Minute Walk Test
Participants are instructed to walk as fast as possible in a sparsely crowded, straight corridor to determine their six-minute walking distance. The cardiorespiratory functional assessment criteria are as follows: walking distance <150 meters is considered severely abnormal, 150-300 meters is moderately abnormal, 301-450 meters is mildly abnormal, and >450 meters is considered normal.
Measured: Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a widely used self-assessment questionnaire for evaluating anxiety and depression symptoms in hospital patients. HADS consists of 14 items, divided into two dimensions: Anxiety and Depression. It uses a Likert 4-point scale, with scores ranging from 0 to 21. Higher scores indicate more severe anxiety and depression symptoms.
Measured: Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.
Postoperative Complications
According to the Clavien-Dindo classification system, Grade I refers to complications that do not require any treatment such as medication or surgery, Grade II involves the need for medication, blood transfusion, or nutritional support, Grade III necessitates surgical or interventional treatment, Grade IV poses a potential threat to the patient's life requiring intensive care, and Grade V results in patient death. The number and severity of postoperative complications are assessed and documented accordingly. Data on complications can be obtained from participants' electronic medical records.
Measured: Postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mengmeng Yuan
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Medical University
- Responsible party
- Sponsor-investigator, Mengmeng Yuan, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366685
- Sponsor's protocol ID
- YJS20230170
- Acronym
- Recovery
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan includes sharing raw data, which requires approval from the corresponding author of the study.
Publications
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.
PubMed 33538338Liu 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.
PubMed 36482832Ma 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.
PubMed 36802111Liu 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.
PubMed 32913857Gupta 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.
PubMed 31550465Hellstadius 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.
PubMed 24895142Ohkura 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.
PubMed 36068609Liu 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.
PubMed 34480622Johns 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.
PubMed 26586494Lee 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.
PubMed 24535848Campbell 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.
PubMed 31626055Anandavadivelan 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.
PubMed 36812121van 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.
PubMed 33837380Hofmann 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.
PubMed 29080597Chinh 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.
PubMed 33456623
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy
- ClinicalTrials.gov ID
- NCT06366685
- Acronym / sponsor ID
- Recovery / YJS20230170
- Conditions
- Esophageal Cancer, Exercise Training, Psychotherapy, Rehabilitation
- Keywords
- Esophageal cancer, Esophagectomy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mengmeng YuanUniversity, hospital or other
- Collaborators
- Anhui Medical University
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Behavioral: Exercise and Psychological InterventionImplementing only exercise intervention for participants, including aerobic exercise, breathing exercises, resistance exercises, with specific exercise regimes tailored to the participants' physical conditions. |
| Mindfulness-Based Stress Reduction Therapy | Experimental | Behavioral: Exercise and Psychological InterventionImplementing only mindfulness-based stress reduction therapy as the main psychological intervention for participants, and dynamically adjusting based on the participants' psychological states. |
| Exercise combined with Mindfulness-Based Stress Reduction Therapy | Experimental | Behavioral: Exercise and Psychological InterventionImplementing intervention combining exercise with mindfulness-based stress reduction therapy for participants, and dynamically adjusting based on the participants' physical and mental recovery status. |
| Routine care | No intervention | –Implementing only the department's routine care for esophageal cancer surgical patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with consciousness disorders.
- Patients with severe physical illnesses who are unable to cooperate with the investigation.
- Participation in other studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and Psychological InterventionTo address the symptoms and severity experienced by esophageal cancer patients after surgery, providing them with exercise or psychological interventions to improve their rehabilitation outcomes. | Behavioural | Exercise combined with Mindfulness-Based Stress Reduction Therapy, Exercise training, Mindfulness-Based Stress Reduction Therapy |
Primary outcome
the Convalescence Symptom Assessment Scale for EsophageCtomy patients (CSAS_EC)
Time frame: 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.
3 secondary outcomes
6-Minute Walk Test
Time frame: Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.
Postoperative Complications
Time frame: Postoperative day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Results publication: PubMed 33538338Sung 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.
- Results publication: PubMed 36482832Liu 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.
- Results publication: PubMed 36802111Ma 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.
- Results publication: PubMed 32913857Liu 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.
- Results publication: PubMed 31550465Gupta 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.
- Results publication: PubMed 24895142Hellstadius 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.
- Results publication: PubMed 36068609Ohkura 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.
- Results publication: PubMed 34480622Liu 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.
- Results publication: PubMed 26586494Johns 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.
- Results publication: PubMed 24535848Lee 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.
- Results publication: PubMed 31626055Campbell 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.
- Results publication: PubMed 36812121Anandavadivelan 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.
- Individual participant dataSharing planned: Yes. The plan includes sharing raw data, which requires approval from the corresponding author of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Psychological Intervention in people with Esophageal Cancer and Exercise Training, run by Mengmeng Yuan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Convalescence Symptom Assessment Scale for EsophageCtomy patients (CSAS_EC) (time frame: Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06366685, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.