Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00591981 |
| Other study ID # |
CC06504 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 2007 |
| Est. completion date |
August 2012 |
Study information
| Verified date |
July 2015 |
| Source |
University of Wisconsin, Madison |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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)
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.
