Assessment of Patient Frailty Prior to Thoracic Surgery

NCT ID: NCT02803281

Last Updated: 2019-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-29

Study Completion Date

2018-11-21

Brief Summary

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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

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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.

Conditions

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Lung Cancer Esophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung Cancer - Frialty Assessment

Patients who will undergo surgery for lung cancer

Frailty Assessment

Intervention Type OTHER

Various physiologic and frailty assessment tests

Esophageal Cancer - Frailty Assessment

Patients who will undergo esophagectomy for esophageal cancer

Frailty Assessment

Intervention Type OTHER

Various physiologic and frailty assessment tests

Interventions

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Frailty Assessment

Various physiologic and frailty assessment tests

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gail E Darling, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network (Toronto General Hospital)

Toronto, Ontario, Canada

Site Status

University Health Network: Toronto General Hospital

Toronto, Ontario, Canada

Site Status

University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 23915593 (View on PubMed)

Talsma 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.

Reference Type BACKGROUND
PMID: 25787705 (View on PubMed)

Makary 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.

Reference Type BACKGROUND
PMID: 20510798 (View on PubMed)

Robinson 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.

Reference Type BACKGROUND
PMID: 19730176 (View on PubMed)

Chen 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.

Reference Type BACKGROUND
PMID: 21843340 (View on PubMed)

Yano 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.

Reference Type BACKGROUND
PMID: 23440240 (View on PubMed)

Fritz S, Lusardi M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys Ther. 2009;32(2):46-9. No abstract available.

Reference Type BACKGROUND
PMID: 20039582 (View on PubMed)

Roberts 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.

Reference Type BACKGROUND
PMID: 21624928 (View on PubMed)

Sheetz 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.

Reference Type BACKGROUND
PMID: 23350746 (View on PubMed)

Rogalla 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.

Reference Type BACKGROUND
PMID: 9725661 (View on PubMed)

Related Links

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http://www.cancer.ca

Canadian Cancer Statistics 2010

Other Identifiers

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15-9170

Identifier Type: -

Identifier Source: org_study_id

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