Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy (Recovery)

April 10, 2024 updated by: Mengmeng Yuan

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 234000
        • Anhui Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shuwen Li, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.
No Intervention: Routine care
Implementing only the department's routine care for esophageal cancer surgical patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-Minute Walk Test
Time Frame: Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.
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.
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.
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.
Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.
Postoperative Complications
Time Frame: Postoperative day 7
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.
Postoperative day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mengmeng Yuan

Collaborators

Anhui Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

April 6, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YJS20230170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The plan includes sharing raw data, which requires approval from the corresponding author of the study.

IPD Sharing Time Frame

Access to the relevant data at the conclusion of this study is permitted, and its usage may be determined based on the needs of the user, subject to approval from the corresponding author of the study.

IPD Sharing Access Criteria

Approval from the corresponding author of the study is required.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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