Research Design

Phase II Research Organization Document

The next section of your research organization document is considered a “mockup”
of your research design. Remember to answer these questions in the discussion forum for
feedback from the instructors. Looking ahead, you will use this document to create a formal
research proposal later in the semester.

Basic Study Components

1. What research design are you pursuing?

We are pursuing a quasi-experimental research design. We will be

answering a specific question with statistical evidence.

2. Do any group members need to obtain IRB approval? [To determine if you need IRB
approval from your clinical site to conduct research, ask your clinical preceptor.
**Note: If you need to obtain IRB approval, you CANNOT use that site for DATA
COLLECTION due to issues in past years. The student at that site should have a
different role in the project (writer or data analysis)]. List each student in the group.

No, all retrospective planning studies are compatible with our research
without the need for new IRB approval at VCU Massey Cancer Center.

3. Will your study be prospective or retrospective?

The study will be retrospective because we will be taking data that has
already been collected and using this to answer our research question.

4. Number of research samples (ex: patients or survey participants) for data collection

We have a large selection of data (over 70 cases) that can be used for
data collection. Before deciding on a specific number of cases to use, we need
to verify some specifications about each patient. We want to limit the
variables within this study and thus want to only use one planning type (VMAT
preferably over IMRT). The location of the tumors and the minimum dose to
the PTV are other factors that need to be assessed before including the
patient’s data in our study. There may be even more cases available that we
can use for this research study if need be. Our goal is to find at least 20
patients that fit the requirements, at a minimum we will include 10 for
publishing purposes.
Data Collection Details
1. How many clinical sites will you be collecting data from?
Data will be collected from one clinical site. VCU Massey Cancer Center.

2. What information are you interested in (if a planning study, list structures for
evaluation; if a study survey, list your study questions)?

We are interested in DVH data for new structures included in planning,

the contralateral esophagus and left anterior descending coronary artery. We
are interested in DVH data for PTV in both original and updated plans to
assess coverage. We are interested in other OAR values included in the clinical
goals of the plans to see potential trends associated with including new OARs.

3. What are your inclusion criteria? Exclusion criteria?

As mentioned before in the research samples section; Our inclusionary

criteria are; location of the tumor in regard to new OAR substructures,
planning modality (VMAT not IMRT), dose fractionation (200cGy) and total
prescription dose above 5940 cGy.

Exclusionary factors associated with the research study would then be

distanced deemed too far away from the OARs to be clinically significant.
Patients who have different dose fractionations or dose prescriptions less
than 60 Gy. Patients that have different treatment modalities (IMRT or 3D).

After speaking with the physicians at my clinic, we determined that

patients should fall into certain categories in order to be included within the
study. All patients whose tumors are within the left lung will be included in
this study as well as those whose right lung tumors are within certain
distances from the contralateral esophagus ( 5cm laterally and 2cm
superior/inferior based on the literature in review). Those who have
subcarinal masses may also be considered due to their circumferential
distance to the OARs. These factors are clinically relevant and limit the
variables within the study.

4. How will you limit the number of variables in your study? (For example, if you are
doing a planning study, only 1 person should be doing the planning to eliminate the
variables.)
 We will be using LAD and contralateral esophagus contours that were
approved by one physician. For creating new VMAT plans that now include
these new OAR structures, we will have one person (Ryan) do the plans. We
will use the same dose constraints for each data set.

5. How will you anonymize your patients? (It is often necessary to transfer data sets or
patient information between group members. It is VERY IMPORTANT that you
respect HIPPA protocols! If you need to transfer data sets between facilities, we can
assist you through ProKnow. If you simply need to transfer data using a
spreadsheet, you must anonymize the patient information. It is up to you to decide
how to do this).

Patient data sets are already approved and anonymized by clinical site.

6. How will you record your data for evaluation? (All anonymized data should be
housed in OneDrive. The data collector may keep a spreadsheet of the anonymized
datasets in the clinic if needed. This should not be shared with anyone outside of the
clinic)

We will record all data in an excel sheet at the clinical site VCU Massey.
Data used for evaluation will be within the Shared One Drive Folder-
Group 1 created by the course instructors.

7. What resources (in addition to the literature search) are available for you to use?

Dose constraint templates, Eclipse TPS, approved data sets, and

contoured structure sets that are physician approved.

8. Previous research study that will be used for data analysis (ex: RTOG study
constraints):

Within the literature review are research studies explaining the

recommendations for dose constraints on new structures. Atkins study for
LAD constraints and Al Halabi study for CE constraints.

LAD: https://pubmed.ncbi.nlm.nih.gov/33331883/

CE: https://pubmed.ncbi.nlm.nih.gov/26104934/
Group Roles
Roles of each group member (members may have multiple roles)

Group Leader-someone who will keep the group on track, make sure group
members are adhering to deadlines, be the direct point of contact for the
instructor with overall questions, update the research organization
document throughout the course of research) Ryan
Data Collector(s)-someone who will be doing the data collection and data
reporting in excel; maintaining journal entries) Ryan
Data analysis-someone who will be responsible for analyzing the raw data,
running any statistical tests and providing conclusive data for the writer
Shannon
Writer-someone who is responsible for writing the outline (later in the
course) and the paper; usually the best writer of the group takes this role
**Only 1 group member can write the paper so that the tone of paper is
consistent. Kerry
Editor This should be ALL group members except the writer
***The highlighted roles are the roles that require the most work and should be split
between all 3 group members. If you have a group of 2, the work must be divided
equally.

Project Template
What project template will you be following? (review the quantitative or qualitative
lecture).

Research paper.