Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool (iDECIDE)
This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.
ID: NCT05407168
Sponsor: Oregon Health & Science University Knight Cancer Institute
Locations: Portland VA Medical Center and Oregon Health & Science University Knight Cancer Institute
VA Lung Cancer Surgery or Stereotactic Radiotherapy (VALOR)
The standard of care for stage I non–small cell lung cancer has historically been surgical resection in patients who are medically fit to tolerate an operation. Recent data now suggest that stereotactic radiotherapy may be a suitable alternative. This includes the results from a pooled analysis of 2 incomplete phase III studies that reported a 15% overall survival advantage with stereotactic radiotherapy at 3 years. While these data are promising, the median follow-up period was short, the results underpowered, and the findings were in contradiction to multiple retrospective studies that demonstrate the outcomes with surgery are likely equal or superior. Therefore, the herein trial aims to evaluate these 2 treatments in a prospective randomized fashion with a goal to compare the overall survival beyond 5 years. It has been designed to enroll patients who have a long life expectancy and are fit enough to tolerate an anatomic pulmonary resection with intraoperative lymph node sampling.
This study is designed to open at VA medical centers with expertise in both treatments. The recruitment process includes shared decision making and multidisciplinary evaluations with lung cancer specialists. Mandatory evaluations before randomization include tissue confirmation of NSCLC, staging with FDG-PET/CT, and biopsies of all hilar and/or mediastinal lymph nodes > 10 mm that have a SUV > 2.5. Prerandomization elective lymph node sampling is strongly encouraged, but not required. Following treatment, patients will be followed for a minimum of 5 years.
ID: NCT02984761
Sponsor: VA Office of Research and Development
Locations: 17 VA medical centers, including VA Long Beach Healthcare System, VA Greater Los Angeles Healthcare System, Bay Pines VA Healthcare System, Miami VA Healthcare System, Edward Hines Jr. VA Hospital, Richard L. Roudebush VA Medical Center, Baltimore VA Medical Center, VA Boston Healthcare System Jamaica Plain Campus, VA Ann Arbor Healthcare System, Minneapolis VA Health Care System, Durham VA Medical Center, Louis Stokes VA Medical Center, Corporal Micheal J. Crescenz VA Medical Center, VA Pittsburgh Healthcare System University Drive Division, Michael E. DeBakey VA Medical Center, Hunter Holmes McGuire VA Medical Center, and Clement J. Zablocki VA Medical Center
Utility of CAML as Diagnostic for Early Stage Lung Cancer
The primary objective of this study is to determine the prevalence of cancer associated macrophage-like cells (CAMLS) in patients with pulmonary nodules. Secondary objectives include the following: determine the positive and negative predictive value of CAMLS in patients with pulmonary nodules who undergo biopsy; model combinations of clinical factors with the presence/absence of CAMLS to refine strategies for assessment of patients with pulmonary nodules; and evaluate whether these measures result in enhanced T-cell activity and/or natural killer cell function and number.
ID: NCT03992183
Sponsor; Collaborators: Fox Chase Cancer Center; US Department of Defense
Locations: Corporal Michael J. Crescenz VA Medical Center and Fox Chase Cancer Center