Thoracic OncoGeriatric Assessment (TOGA) Trials (TOGA)

June 1, 2023 updated by: University of Wisconsin, Madison

Preoperative Oncogeriatric Assessment for Thoracic Malignancies

Our goal is to develop a reliable, physician and patient-friendly, pre-operative Thoracic Onco-Geriatric Assessment (TOGA) to predict surgical risk in geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus, modeled upon existing CGA tools, including the Preoperative Assessment of Cancer in the Elderly (PACE)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our proposed TOGA wil consist of portions of the PACE and some additional screening tools, and will be applied prospectively to all patients 70 years old and above seen in the UWCCC for a thoracic oncology surgery. Residents of nursing homes and assisted living facilities will be eligible for this study if they are thought to be appropriate surgical candidates; other institutionalized patients will not. The preoperative TOGA will be performed by either Drs. Weigel, Maloney, LoConte or Traynor or P.A. Block. The TOGA includes parts of the PACE, involving assessment of co-morbid illness, Activities of Daily Living [ADL], Instrumental Activities of Daily Living [IADL], Geriatric Depression Screen [GDS], Brief Fatigue Inventory [BFI], Eastern Cooperative Oncology Group/Zubrod Performance Status [PS], Mini Mental State Exam (MMSE), in addition to an American Society of Anesthesiologists Score[ASA] and mini nutritional assessment (MNA), which were not done in the PACE. The TOGA should take up to 25 minutes to complete (Audisio, 2006), and will be done at only one time preoperativelOur hypothesis is that this novel, preoperative Thoracic Onco Geriatric Assessment (TOGA) will serve to predict outcomes for older patients going though thoracic oncology surgery, and thus will enhance geriatric patient care through the development of concise, validated, preoperative risk stratification.

Our hypothesis is that this abbreviated geriatric screening tool will be a better predictor for surgical and oncologic complications after surgery than performance status alone (which is currently the only measure of fitness used in routine oncology care). In addition, we predict that parts of the TOGA, specifically the instrumental activites of daily living score (IADL), mini nutritional assessment (MNA) and the brief fatigue inventory (BFI), will be the strongest predictor(s) of outcomes in our thoracic surgery population. The outcomes data we generate will also be important in quality improvement and standardization of preoperative risk assessment for elderly patients with thoracic malignancies.

Study Type

Observational

Enrollment (Actual)

14

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

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Of Wisconsin 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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus.

Description

Inclusion Criteria:

  • Patients 70 years old and above seen in the UWCCC for a thoracic oncology surgery.
  • Residents of nursing homes and assisted living facilities will be eligible for this study if they are thought to be appropriate surgical candidates.

Exclusion Criteria:

  • Institutionalized deemed not to be appropriate.
  • Prisoners

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
Primary
All patients 70 years old and above scheduled for a thoracic oncologic surgery (typically esophageal or lung cancer) will be approached for entry into this study
Behavioral: TOGA Tools
ADL's, Zubrod, IADL's, BFI, MMS, MNS, GDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morbidity (Cardiac, pulmonary, infectous, etc.) and Mortality in Cohort
Time Frame: 30days
30days

Collaborators and Investigators

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

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Tracey L Weigel, MD, University of Wisconsin Dept of Surgery CardioThoracic Division

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

August 1, 2007

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimated)

January 11, 2008

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC06504

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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