lung cancer patients with air flow limitation scheduled for surgical treatment
Conditions
Interventions
Preoperative telerehabilitation intervention: After enrollment, the Fitbit Inspire 3 will be placed on the wrist of the patients. A web interview will be conducted within 14 days of patient enrollment
Sponsors
Ohde Yasuhisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) age>=18 2) ECOG performance status (PS) is 0, 1, or 2. 3) Primary lung cancer or metastatic lung cancer is suspected or diagnosed. 4) Surgical treatment is scheduled between 7 and 28 days after registration. 5) Anatomical lung resection is planned. 6) Pulmonary function tests are available. 7) FEV1% [FEV1/FVC] < 70% or the patient has already been diagnosed with chronic obstructive pulmonary disease (COPD). 8) Patients has no history of bronchial asthma. 9) Patients who possess a smart phones. 10) Main organ function other than the lungs is preserved, and the physician determines that general anesthesia is feasible. 11) The patient has given a full explanation of the study and obtained written consent prior to enrollment in the study.
Exclusion criteria
Exclusion criteria: 1) Patients with synchronous or metachronous malignancies, including multiple lung cancers that are judged to require surgical treatment within six months at the time of enrollment (patients with multiple lung cancers that are scheduled for simultaneous resection or other malignancies that are judged to be completely resectable by endoscopic resection are not excluded.)Patients with synchronous or metachronous malignancies, including multiple lung cancers, scheduled for treatment at the time of enrollment (patients with only multiple lung cancers scheduled forsimultaneous resection are not excluded) 2) Patients with local infections requiring treatment or active systemic infections requiring treatment( Patients under observation only are not excluded)Persons with localized or systemically active infections requiring medical attention 3) Pregnant, lactating, or women who may be currently pregnant 4) Patients with a history of myocardial infarction or anginal attack within the past 6 months 5) Patients with a history of cerebrovascular disease whose symptoms persist at the time of enrollment 6) Patients with uncontrolled hypertension 7) Patients who are considered to have difficulty performing the six-minute walking test due to orthopedic conditions, or other reasons 8) Patients with clinically problematic psychiatric disorders that would preclude enrollment in this study 9) Patients who use a pacemaker, implantable cardioverter-defibrillator, or other medical devices that could be affected by magnetic materials 10) Patients with a history of hypersensitivity to silicon, rubber products, or metals 11) Patients with a history of serious hypersensitivity 12) Patients deemed inappropriate for registration by the physician in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Six-minute walking distance (difference between preoperative and three months after surgery) | — |
Secondary
| Measure | Time frame |
|---|---|
| Six-minute walking distance (difference between preoperative and six months after surgery) Feasibility of Fitbit Inspire 3 (heart rate data acquisition rate) QOL (CAT [COPD Assessment Test] (Japanese), EQ5D5L [EuroQol 5 dimensions 5-level] Japanese version) PRO response collection rate Postoperative complications Postoperative respiratory function Resting heart rate Adverse events | — |
Contacts
Public ContactShinya Katsumata
Shizuoka Cancer Center
Outcome results
None listed