A Randomized Controlled Study of the Out-patient Rehabilitation Intervention following Thoracic Esophageal Cancer Surgery
- Conditions
- Thoracic esophageal cancer
- Registration Number
- JPRN-UMIN000049498
- Lead Sponsor
- Japanese Association of Supportive Care in Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 153
Not provided
1) Patient has an infectious disease requiring systemic treatment. 2) Has a fever of 38 degrees or higher. 3) Pregnant, possibly pregnant, or lactating female patients. 4) Patients with psychosis or concomitant psychiatric symptoms that would preclude participation in the study. 5) Receiving continuous systemic administration (oral or intravenous) of steroids. 6) Patient has uncontrolled diabetes mellitus (HbA1c > 8%). 7) Patient has uncontrolled hypertension. 8) Complicated with unstable angina pectoris (angina with onset or worsening within the last 3 weeks) or a history of myocardial infarction within 6 months. 9) Complicated interstitial pneumonia, pulmonary fibrosis, severe emphysema, or acute heart failure. 10) Has a history of cerebrovascular disease (e.g., cerebral infarction, intracerebral hemorrhage, transient ischemic attack) occurring within 6 months. 11) Has an active overlapping cancer. 12) Other patients deemed by the treating physician to be unsuitable for enrollment in this clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Shuttle Walking Test (SWT) distance at 3 months from discharge (T4)
- Secondary Outcome Measures
Name Time Method 1) Participation rate of outpatient rehabilitation intervention, diary entries and collection rate for Group A 2) Percentage of Group A reaching intervention goals (percentage of weeks in which prescribed strength training was performed at least 2 days per week, percentage of weeks in which target number of steps was achieved at least 5 days per week) 3) Incidence of serious adverse events in group A 4) The following items in groups A and B at 3 months (T4), 6 months (T5), and 12 months (T6) after discharge Motor function (SWT distance, grip strength, 5 times chair stand test, physical activity) Skeletal muscle mass (measured by CT), diagnostic criteria for sarcopenia Nutritional status (body weight, CONUT (total lymphocyte count, Alb, TC)) Functional assessment of the elderly (G8) Quality of life (EORTC-QLQ-C30) Utilization of medical resources (cumulative length of hospital stay) Serious adverse events