Research Design 

Phase II Research Organization Document 

Basic Study Components 
1.      What research design are you pursuing? 
 Our group will pursue a quantitative-experimental research design.  

2.      Do any group members need to obtain IRB approval?  

 Nicole Peckham (does not require IRB approval)  
 Stacey Song     (does not require IRB approval)                  
 Carlos Torres Teran (will not apply for IRB approval)  
 
3.      Will your study be prospective or retrospective? 
 Our study will be retrospective as we will be planning and comparing the 3D
Conformal Hybrid Arc to VMAT technique.
 
4.      Number of research samples (ex: patients or survey participants) for data collection. 
 A minimum of 6 cases, but ideally 10-12 cases will be used for data collection. 

Data Collection Details 

1.      How many clinical sites will you be collecting data from? 
 One clinical site will be used for treatment planning and data collection.
 
2.      What information are you interested in?     
 Whether target coverage comparable to VMAT can be achieved with a 3D Conformal
Hybrid Arc plan
 Whether VMAT constraints can be achieved with a 3D Conformal Hybrid Arc plan
 Structures of interest include spinal cord, esophagus, lungs, heart, and PTV.

3.      What are your inclusion criteria? Exclusion criteria? 

 Inclusion criteria:
o Physician-ordered 3D cases or insurance denied VMAT cases where 3D would be
the only option.  
o Candidates for a 3D Conformal Hybrid Arc plan for treatment to the
mediastinum, with similar stage disease.
o Patients with similar body habitus.

 
 Exclusion criteria: 
o Patients with abnormally shaped tumors. 
o Patients that are not suitable candidates for a 3D Conformal Hybrid Arc plan due
to their condition.

 
 4.      How will you limit the number of variables in your study? 
 Only one clinical site will be used to collect patient data. Focusing on mediastinal
cases, the same plan design and objectives will be used for the creation of each plan.
All plans will be created in the same TPS, on the same machine model, with
treatment planning CTs collected on the same CT simulator. Patients with similar
body habitus and stage will be selected. All target contours will be approved by the
same physician or a consensus of all five physicians at the clinic site collecting data.
All normal structure contours will be performed by the same person who will be
creating the treatment plans for comparison. In order to eliminate bias from the clinic
collecting the data, a physicist from each clinic site will be reviewing the treatment
plans.
 
5.      How will you anonymize your patients?  
 The clinical site that will be doing the data collection will be using MIM Maestro
which can anonymize patient data sets. Once anonymized, the data can be carried
through the planning process. After being planned the RT plan, RT dose and RT
structures are stored in MIM and can be sent to other clinics via cloud-
based technology. The dosimetrists and physicists at the data collection site will be
finding cases that fit our inclusion criteria and anonymizing the patient data, so it is
blind to all members of the research group.
 
6.      How will you record your data for evaluation?  
 For our study we will use Excel spreadsheets to hold all anonymized patient data.
These documents will be housed in OneDrive.  
 
7.      What resources (in addition to the literature search) are available for you to
use?                    
 Resources that are available for our use include highly experienced personnel
(dosimetrists, physicists, physicians, etc.) from each of our respective clinical sites as
well as our course instructors. The clinic site doing the data collection has access to
MIM Maestro and RayStation.
 
8.      Previous research study that will be used for data analysis (ex: RTOG study
constraints): 
 NCCN guidelines for acceptable treatment options and RTOG dose constraints. 
 
Group Roles 
Roles of each group member (members may have multiple roles) 
 Nicole Peckham (Group Leader, Data Collector and Editor) 
 Stacey Song (Data Analysis and Editor)   
 Carlos Torres Teran (Writer) 
 
Project Template 
What project template will you be following?  
 Our study will follow the case study template.