Thoracic OncoGeriatric Assessment (TOGA) Trials

Completed

• Conditions: Esophagus Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Pleural Neoplasms; Thymus Neoplasms
• Interventions: Behavioral: TOGA Tools

• Registration Number: NCT00591981
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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)

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-11
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2015-07
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary	TOGA Tools	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

Primary Outcome Measures

Name	Time	Method
Morbidity (Cardiac, pulmonary, infectous, etc.) and Mortality in Cohort	30days

Trial Locations

Locations (1)

University of Wisconsin Hospital; 🇺🇸 Madison, Wisconsin, United States