Assessment of Patient Frailty Prior to Thoracic Surgery

May 4, 2019 updated by: University Health Network, Toronto

Assessment of Patient Frailty Prior to Thoracic Surgery: A Feasibility Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network (Toronto General Hospital)
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network: Toronto General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cancer Patients - Lung or Esophageal

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lung Cancer - Frialty Assessment
Patients who will undergo surgery for lung cancer
Other: Frailty Assessment
Various physiologic and frailty assessment tests
Esophageal Cancer - Frailty Assessment
Patients who will undergo esophagectomy for esophageal cancer
Other: Frailty Assessment
Various physiologic and frailty assessment tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility Assessment
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Gail E Darling, MD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2015

Primary Completion (Actual)

July 29, 2018

Study Completion (Actual)

November 21, 2018

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 4, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-9170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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