Assessment of Patient Frailty Prior to Thoracic Surgery
1 other identifier
observational
40
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2015
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 29, 2015
CompletedFirst Submitted
Initial submission to the registry
June 14, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2018
CompletedMay 7, 2019
May 1, 2019
3 years
June 14, 2016
May 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility Assessment
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
Study Arms (2)
Lung Cancer - Frialty Assessment
Patients who will undergo surgery for lung cancer
Esophageal Cancer - Frailty Assessment
Patients who will undergo esophagectomy for esophageal cancer
Interventions
Various physiologic and frailty assessment tests
Eligibility Criteria
Cancer Patients - Lung or Esophageal
You may qualify if:
- Patients with Esophageal or Lung Cancer who will undergo resectional surgery.
You may not qualify if:
- Patients undergoing diagnostic or staging procedures or pulmonary wedge excisions will be excluded.
- Patients unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University Health Network (Toronto General Hospital)
Toronto, Ontario, M5G 2C4, Canada
University Health Network: Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
University Health Network
Toronto, Ontario, M5G 2C4, Canada
Related Publications (10)
Hodari A, Hammoud ZT, Borgi JF, Tsiouris A, Rubinfeld IS. Assessment of morbidity and mortality after esophagectomy using a modified frailty index. Ann Thorac Surg. 2013 Oct;96(4):1240-1245. doi: 10.1016/j.athoracsur.2013.05.051. Epub 2013 Jul 31.
PMID: 23915593BACKGROUNDTalsma AK, Damhuis RA, Steyerberg EW, Rosman C, van Lanschot JJ, Wijnhoven BP. Determinants of improved survival after oesophagectomy for cancer. Br J Surg. 2015 May;102(6):668-75. doi: 10.1002/bjs.9792. Epub 2015 Mar 18.
PMID: 25787705BACKGROUNDMakary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
PMID: 20510798BACKGROUNDRobinson TN, Eiseman B, Wallace JI, Church SD, McFann KK, Pfister SM, Sharp TJ, Moss M. Redefining geriatric preoperative assessment using frailty, disability and co-morbidity. Ann Surg. 2009 Sep;250(3):449-55. doi: 10.1097/SLA.0b013e3181b45598.
PMID: 19730176BACKGROUNDChen CH, Ho-Chang, Huang YZ, Hung TT. Hand-grip strength is a simple and effective outcome predictor in esophageal cancer following esophagectomy with reconstruction: a prospective study. J Cardiothorac Surg. 2011 Aug 15;6:98. doi: 10.1186/1749-8090-6-98.
PMID: 21843340BACKGROUNDYano Y, Inokuchi T, Kario K. Walking speed is a useful marker of frailty in older persons. JAMA Intern Med. 2013 Feb 25;173(4):325-6. doi: 10.1001/jamainternmed.2013.1629. No abstract available.
PMID: 23440240BACKGROUNDFritz S, Lusardi M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys Ther. 2009;32(2):46-9. No abstract available.
PMID: 20039582BACKGROUNDRoberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
PMID: 21624928BACKGROUNDSheetz KH, Zhao L, Holcombe SA, Wang SC, Reddy RM, Lin J, Orringer MB, Chang AC. Decreased core muscle size is associated with worse patient survival following esophagectomy for cancer. Dis Esophagus. 2013 Sep-Oct;26(7):716-22. doi: 10.1111/dote.12020. Epub 2013 Jan 25.
PMID: 23350746BACKGROUNDRogalla P, Meiri N, Hoksch B, Boeing H, Hamm B. Low-dose spiral computed tomography for measuring abdominal fat volume and distribution in a clinical setting. Eur J Clin Nutr. 1998 Aug;52(8):597-602. doi: 10.1038/sj.ejcn.1600612.
PMID: 9725661BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail E Darling, MD
University Health Network, Toronto
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2016
First Posted
June 16, 2016
Study Start
July 29, 2015
Primary Completion
July 29, 2018
Study Completion
November 21, 2018
Last Updated
May 7, 2019
Record last verified: 2019-05