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

NCT06366685 | Not Yet Recruiting

• 1 other identifier: YJS20230170
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer; Exercise Training; Psychotherapy; Rehabilitation

Keywords

Esophageal cancer; Esophagectomy; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.

Secondary Outcomes (3)

• 6-Minute Walk Test

  Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.

• Hospital Anxiety and Depression Scale (HADS)

  Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.

• Postoperative Complications

  Postoperative day 7

Study Arms (4)

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.

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.

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.

Behavioral: Exercise and Psychological Intervention

Routine care

NO INTERVENTION

Implementing only the department's routine care for esophageal cancer surgical patients.

Interventions

Exercise and Psychological Intervention BEHAVIORAL

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; Exercise training; Mindfulness-Based Stress Reduction Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with consciousness disorders.
• Patients with severe physical illnesses who are unable to cooperate with the investigation.
• Participation in other studies.

Sponsors & Collaborators

• Mengmeng Yuan: lead
• Anhui Medical University: collaborator

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 234000, China

Location

Related Publications (16)

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  PMID: 36068609 RESULT

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  PMID: 34480622 RESULT

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  PMID: 26586494 RESULT

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  PMID: 31626055 RESULT

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  PMID: 32040222 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Exercise; Psychosocial Intervention

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 16, 2024
• Study Start: May 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: February 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• Access Criteria: Approval from the corresponding author of the study is required.

Locations

CN (1)