Research Organization Document

Phase II
Basic Study Components
1. What research design are you pursuing?

Experimental. The research hypothesis (H1) is that using a 3D milled rigid bolus
with VMAT will increase surface dose homogeneity. Research hypothesis (H 2) is that
using a 3D milled rigid bolus with VMAT will increase the percentage of planning
target volume (PTV) receiving prescription dose. This design will enable us to
complete a retrospective case study investigating the effectiveness of 3D milled
bolus for total and partial scalp irradiation.

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.
Existing IRB exists for patient subset. We have been added as investigators.  No
additional IRB is required.

3. Will your study be prospective or retrospective?

This study will be retrospective. This facility has been successfully implementing the
use of 3D milled bolus for total and partial scalp treatment clinically for some
duration of time. Thus, a new prospective innovation is not required as there has
been sufficient success. This case study is to evaluate that success metrically and
document the methodology.

4. Number of research samples (ex: patients or survey participants) for data collection
Currently we have 8 patients who have been treated using 3D milled wax based 1cm
rigid bolus for scalp irradiation. Our chief physicist is developing a script to search
our database for more using the ICD-10 codes and we expect to find at least 2-3
more patients. After speaking with our chief head and neck physician, he thinks we
will have another 1-2 patients in the coming months. Again, our sample size is going
to be small, but this is still a very young treatment method we plan on evaluating.

Data Collection Details

1. How many clinical sites will you be collecting data from?
 We will be collecting data from just one clinical site. This will streamline the
accessibility of data sharing and decreases the amount of planning variations
between clinical sites.

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 the dose variation between the planned dose and delivered
dose to the scalp using the in-vivo measurements taken between the first three
fractions using optically stimulated luminescence device’s (OSLD) placed at various
locations on the scalp. All of the measurements will be averaged to get the mean
dose delivered and then compared to the prescription dose. Evaluation of the
planning method to increase homogeneity will include the use of the TPS modeling
of the VMAT plan utilizing individualized jaw-blocking and flash creation within the
bolus material itself using expansion structures off of the PTV. This information will
be confirmed with the in-vivo measurements.

3. What are your inclusion criteria? Exclusion criteria?

Inclusion:
 Male or Female total or partial scalp irradiation patients who were treated at
The James Cancer Hospital
 Scalp irradiation patients with TLD/OSLD invivo measurement devices
within the first 3 fractions of treatment
 Those scalp irradiation patients who were treated with a 3D milled bolus
 Scalp irradiation patients who were imaged using CBCT with a frequency of
at least once a week

Exclusion:

 Those who did not finish treatment

 Those who were not treated using VMAT or IMRT
 Those who were not treated using 3D milled wax based 1cm rigid bolus
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.)
In order to limit variables, only samples that have been treated with a 1cm 3D
milled wax based bolus that have optically stimulated luminescence device
measurements to verify skin dose will be used in this study. The treatment planning
process will also only include the use of VMAT and IMRT planned patients using a
6MV photon beam produced on Varian True Beam Linear accelerators.
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).
Since we are at the same clinical site, we will be able to reference our patient data
base without transferring their data offsite. However, when it is necessary to include
patient information in our report, we will assign a randomized number/letter
sequence to the patients name and will compile this information into a master list
and store it on our secure and encrypted medical center desktop for reference.
Should we include screenshots of a patient or any information directly linked to the
patient’s identity, we will block it out using a black box (ie. Setup photos- block out
face).

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 the data on our shared drives here at the medical center that are
encrypted and secure. Both of us have access to each other’s share drives and when
the data needs to be uploaded, we can each do so accordingly. Data will be
anonymized at the time of collection.

7. What resources (in addition to the literature search) are available for you to use?
We have staffed dosimetrists, physicists, and the chief head and neck doctor that
oversees these treatments available that are willing to answer any and all
questions/concerns during our research process. Also, we have access to the
medical center library and online data base’s.

8. Previous research study that will be used for data analysis (ex: RTOG study
constraints):
At The James Cancer Hospital, we have planning objectives that the doctors attach to
a treatment plan. We will be using these planning objectives based off of numerous
RTOG, QUANTEC, and MOBIUS studies for data analysis and dose constraints.
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)
Data Collector(s)-someone who will be doing the data collection and data
reporting in excel; maintaining journal entries)
Data analysis-someone who will be responsible for analyzing the raw data,
running any statistical tests and providing conclusive data for the writer
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.
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).

Quantitative- as of right now, we will be approaching this research project like it is a case
study due the limited amount of patients who have received this treatment. However, as
mentioned above, our head and neck physicians as a group believe that we will have more
cases like this in the near future to include in the study. We also are choosing a quantitative
approach in order to evaluate the cause and effect relationship this type of treatment
planning and delivery accomplishes in clinic.