Determining the Feasibility of Post-Operative Training for Patients Diagnosed With Non-Small Cell Lung Cancer
Using a single-group, prospective design, potential participants will be identified and
screened for eligibility by the PI (LWJ) via medical record review of patients scheduled for
their primary adjuvant chemotherapy consultation at DUMC and Durham VA. As a routine part of
clinical care, during the treatment consultation the attending oncologist will perform a
physical examination to screen for cardiovascular risk factors, the results of which will be
recorded in the patients' medical records. Immediately following their consultation and
oncologist approval, potential participants will be provided with a thorough review of the
study by the principal investigator (LJ) and asked if they are willing to participate.
Interested participants will be given an information package that provides further
information on study participation. Two to five days following their treatment consultation
and prior to the initiation of chemotherapy, interested participants will be contacted by
telephone by the PI to answer any questions and to schedule the baseline assessment visit.
At the baseline visit, participants will be asked to sign the informed consent and will be
given a copy for their records. After consent, they will be given a baseline ECG and
physician monitored cardiopulmonary exercise test (stress test) to screen for undiagnosed
cardiovascular disease. Following the successful completion of baseline assessments, all
participants will be scheduled for their initial exercise training session. Finally, on a
different group of patients we will perform a random retrospective medical chart review of
50 completely-resected NSCLC patients who received usual care (i.e., no exercise training)
during the study period to obtain comparative information on the treatment
toxicity/compliance rate. The chart review will be performed by Drs. Jones, Garst and
Crawford and will assess treatment toxicity and compliance over the entire course of
adjuvant chemotherapy.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
ECG stress test
8 weeks, 16 weeks
No
Lee Jones, PhD
Principal Investigator
Duke University Health System
United States: Institutional Review Board
8257
NCT00636571
March 2006
March 2008
Name | Location |
---|---|
Duke University Health System Preston Robert Tisch Brain Tumor Center | Durham, North Carolina 27710 |