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

Mengmeng Yuan

Status: Not yet enrolling

Conditions: Rehabilitation; Exercise Training; Esophageal Cancer; Psychotherapy

Treatments: Behavioral: Exercise and Psychological Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06366685

YJS20230170

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

Exercise training

Experimental group

Description:

Implementing only exercise intervention for participants, including aerobic exercise, breathing exercises, resistance exercises, with specific exercise regimes tailored to the participants' physical conditions.

Treatment:

Behavioral: Exercise and Psychological Intervention

Mindfulness-Based Stress Reduction Therapy

Experimental group

Description:

Implementing only mindfulness-based stress reduction therapy as the main psychological intervention for participants, and dynamically adjusting based on the participants' psychological states.

Treatment:

Behavioral: Exercise and Psychological Intervention

Exercise combined with Mindfulness-Based Stress Reduction Therapy

Experimental group

Description:

Implementing intervention combining exercise with mindfulness-based stress reduction therapy for participants, and dynamically adjusting based on the participants' physical and mental recovery status.

Treatment:

Behavioral: Exercise and Psychological Intervention

Routine care

No Intervention group

Description:

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