Clinical trial NCT06366685: Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy
Official title: Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Exercise Training
Psychotherapy
Rehabilitation
Keywords: Esophageal cancer
Esophagectomy
Rehabilitation
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
Collaborators: name: Anhui Medical University
First posted: 2024-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: the Convalescence Symptom Assessment Scale for EsophageCtomy patients (CSAS_EC)
timeFrame: Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.
Secondary outcomes:
measure: 6-Minute Walk Test
timeFrame: Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Preoperative and Postoperative day 7 and through study completion, on average, 40 days post-surgery.
measure: Postoperative Complications
timeFrame: Postoperative day 7
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
References:
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