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

Not Applicable

Not yet recruiting

• Conditions: Exercise Training; Rehabilitation; Psychotherapy; Esophageal Cancer
• Interventions: Behavioral: Exercise and Psychological Intervention

• Registration Number: NCT06366685
• Lead Sponsor: Mengmeng Yuan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-06
• Study First Submitted QC: 2024-04-10
• Last Update Submitted: 2024-04-10
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Study Start: 2024-05-01
• Primary Completion: 2024-10-31
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise combined with Mindfulness-Based Stress Reduction Therapy	Exercise and Psychological Intervention	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 training	Exercise and Psychological Intervention	Implementing 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	Exercise and Psychological Intervention	Implementing only mindfulness-based stress reduction therapy as the main psychological intervention for participants, and dynamically adjusting based on the participants' psychological states.

Primary Outcome Measures

Name	Time	Method
the Convalescence Symptom Assessment Scale for EsophageCtomy patients (CSAS_EC)	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.

Secondary Outcome Measures

Name	Time	Method
6-Minute Walk Test	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.
Hospital Anxiety and Depression Scale (HADS)	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.
Postoperative Complications	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.

Trial Locations

Locations (1)

Anhui Medical University; 🇨🇳 Hefei, Anhui, China