|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Wisconsin, Madison |
|---|---|
| Information provided by: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00591981 |
Purpose
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)
| Condition | Intervention |
|---|---|
|
Thoracic Neoplasms Lung Neoplasms Esophagus Neoplasms Pleural Neoplasms Thymus Neoplasms |
Behavioral: TOGA Tools |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Preoperative Oncogeriatric Assessment for Thoracic Malignancies |
| Enrollment: | 14 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Wisconsin | |
| University of Wisconsin Hospital | |
| Madison, Wisconsin, United States, 53792 | |
| Principal Investigator: | Tracey L Weigel, MD | University of Wisconsin Dept of Surgery CardioThoracic Division |
More Information
| Responsible Party: | Dr Tracey Weigel , MD, FACS, FCCP Associate Professor, University of Wisconsin DEpartment of Surgery CardioThoracic Division |
| ClinicalTrials.gov Identifier: | NCT00591981 History of Changes |
| Other Study ID Numbers: | M-2006-0352 |
| Study First Received: | December 26, 2007 |
| Last Updated: | January 10, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Geriatric Thoracic neoplasm (Patients over 70 years of age) Geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus. |
|
Neoplasms Esophageal Neoplasms Lung Neoplasms Pleural Neoplasms Thoracic Neoplasms Thymus Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Respiratory Tract Neoplasms Lung Diseases Respiratory Tract Diseases Pleural Diseases Lymphatic Diseases |
