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Trial Title:
Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy
NCT ID:
NCT06366685
Condition:
Esophageal Cancer
Exercise Training
Psychotherapy
Rehabilitation
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
Esophageal cancer
Esophagectomy
Rehabilitation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise and Psychological Intervention
Description:
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.
Arm group label:
Exercise combined with Mindfulness-Based Stress Reduction Therapy
Arm group label:
Exercise training
Arm group label:
Mindfulness-Based Stress Reduction Therapy
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 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Medical University
Address:
City:
Hefei
Zip:
234000
Country:
China
Contact:
Last name:
Mengmeng Yuan, Graduate
Phone:
18205575607
Email:
2510950595@qq.com
Contact backup:
Last name:
Shaoxue Li, Graduate
Phone:
18712335223
Email:
2581558674@qq.com
Investigator:
Last name:
Shuwen Li, Professor
Email:
Principal Investigator
Start date:
May 1, 2024
Completion date:
February 1, 2025
Lead sponsor:
Agency:
Mengmeng Yuan
Agency class:
Other
Collaborator:
Agency:
Anhui Medical University
Agency class:
Other
Source:
Anhui Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06366685
