Clinical trial NCT00591981: Thoracic OncoGeriatric Assessment (TOGA) Trials
Official title: Preoperative Oncogeriatric Assessment for Thoracic Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Neoplasms
Lung Neoplasms
Esophagus Neoplasms
Pleural Neoplasms
Thymus Neoplasms
Keywords: Geriatric
Thoracic
neoplasm
(Patients over 70 years of age) Geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus.
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 14
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Morbidity (Cardiac, pulmonary, infectous, etc.) and Mortality in Cohort
timeFrame: 30days
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Dept of Surgery CardioThoracic Division
name: Tracey L Weigel, MD
role: PRINCIPAL_INVESTIGATOR
References: