Thoracic OncoGeriatric Assessment (TOGA) Trials - Full Text View

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:	Cohort, Prospective
Official Title:	Preoperative Oncogeriatric Assessment for Thoracic Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Lung Cancer Thymus Cancer

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Morbidity (Cardiac, pulmonary, infectous, etc.) and Mortality in Cohort [ Time Frame: 30days ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591981

Locations

United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Tracey L Weigel, MD

University of Wisconsin Dept of Surgery CardioThoracic Division

More Information

No publications provided

Responsible Party:	University of Wisconsin DEpartment of Surgery CardioThoracic Division ( Dr Tracey Weigel , MD, FACS, FCCP Associate Professor )
Study ID Numbers:	M-2006-0352
Study First Received:	December 26, 2007
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00591981 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

Geriatric
Thoracic
neoplasm
(Patients over 70 years of age) Geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus.

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Pleural Diseases
Esophageal Neoplasms
Lymphatic Diseases
Neoplasms
Neoplasms by Site

Digestive System Diseases
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Head and Neck Neoplasms
Thymus Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Pleural Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009