A Feasibility study of an Out-patient Rehabilitation Intervention for the Postoperative Patients with Thoracic Esophageal Cancer Surgery

Phase 2

• Conditions: Esophageal Cancer

• Registration Number: JPRN-UMIN000032246
• Lead Sponsor: Japanese Association of Supportive Care in Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-14
• Study Completion: 2021-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of participation in outpatient rehabilitation

Secondary Outcome Measures

Name	Time	Method
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