Esophageal Cancer
Conditions
Interventions
Out-patient Rehabilitation
Sponsors
Japanese Association of Supportive Care in Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary enrollment 1) Scheduled to undergo radical thoracotomy/laparotomy (including endoscopic surgery) for thoracic esophageal cancer 2) Written informed consent for primary enrollment 3) Aged 20-80 years 4) Eastern Cooperative Oncology Group performance status of 0 or 1 5) Sufficient organ function Secondary enrollment 1) SWT score has decreased 20% or more 2) Written informed consent for secondary enrollment 3) Without apparent sign of recurrence 4) Scheduled to be discharged within 30 days after radical surgery 5) Without adjuvant therapy 6) Eastern Cooperative Oncology Group performance status of 0 to 2 7) Sufficient organ function 8) Possible of outpatient visit
Exclusion criteria
Exclusion criteria: 1) Active infection requiring systemic therapy 2) Fever of 38 degrees or more 3) Pregnancy, possible pregnancy or breastfeeding 4) Psychiatric disease 5) Patients requiring systemic steroid medication 6) Poorly controlled diabetes mellitus 7) Poorly controlled hypertension 8) Unstable angina within 3 weeks or with a history of myocardial infarction within 6 month 9) Severe pulmonary pneumonitis, fibrosis, emphysema or heart failure 10) history of cerebral vascular disorder (cerebral infarction, intracerebral hemorrhage, transient ischemic attack, etc.) within 6 month 11) Synchronous active malignancies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of participation in outpatient rehabilitation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Occurrences of events with limited tolerability for outpatient rehabilitation interventions 2. Safety 3. Rationales for nonparticipation/ withdrawal 4. Journal entry and collection rates until three months after discharge (T4 point) 5. Achievement status of intervention goals 1) Percentage of weeks in which the prescribed muscle training regimen has been performed on two or more days 2) Percentage of weeks in which the target number of steps has been reached on five or more days | — |
Countries
Japan
Contacts
Public ContactYutaka Miyawaki
Saitama Medical University International Medical Center Gastroenterological Surgery
Outcome results
None listed