Assessment of Patient Frailty Prior to Thoracic Surgery

Completed

• Conditions: Lung Cancer; Esophageal Cancer
• Interventions: Other: Frailty Assessment

• Registration Number: NCT02803281
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Determine the feasibility of assessment of measures of frailty and determine if these measures provide a clinically important contribution of risk assessment in a population of patients undergoing major thoracic surgery for lung or esophageal cancer.

Detailed Description

Both gastro-esophageal and lung cancers are major causes of morbidity and mortality worldwide. In Canada the incidence for Esophageal Adenocarcinoma has doubled in the last two decades, while lung cancer is the leading cause of cancer death. Surgery is a treatment option for these patients; however, esophagectomy in particular, is associated with significant morbidity, mortality and adverse effect on quality of life. Despite satisfactory standard preoperative testing to evaluate risk for surgery, some patients experience morbidity and never recover fully from surgery. Frailty assessment may offer a more sensitive measure of a patient's physiologic reserve, which may allow identification of patients who are poor candidates for surgery. There is a lack of consensus of how best to assess frailty prior to surgery. This study aims to analyze frailty assessment as a tool for patient selection for surgery.

Study Timeline

• Study Start: 2015-07-29
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-16
• Primary Completion: 2018-07-29
• Study Completion: 2018-11-21
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-04
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with Esophageal or Lung Cancer who will undergo resectional surgery.

Exclusion Criteria

• Patients undergoing diagnostic or staging procedures or pulmonary wedge excisions will be excluded.
• Patients unable to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Esophageal Cancer - Frailty Assessment	Frailty Assessment	Patients who will undergo esophagectomy for esophageal cancer
Lung Cancer - Frialty Assessment	Frailty Assessment	Patients who will undergo surgery for lung cancer

Primary Outcome Measures

Name	Time	Method
Feasibility Assessment	2 years	Determine the feasibility of assessment of measures of frailty and determine if these measures provide a clinically important contribution of risk assessment in a population of patients undergoing major thoracic surgery for lung or esophageal cancer.

Trial Locations

Locations (3)

University Health Network: Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

University Health Network (Toronto General Hospital); 🇨🇦 Toronto, Ontario, Canada