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?
 Group 3 is pursuing an experimental research design.

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.

 Currently, IRB approval is not required per clinical preceptors at two of the
three facilities.
 Members include:

 Billings Cancer Institute – Billings, Montana
 Billings does not require IRB approval, but a Privacy &
Exemption submission is required and will be reviewed next
month (May 2023).
 Kristen Eberhard
 St. Luke’s Cancer Center – Boise, Idaho
 Allison Wright
 OU Health Stephenson Cancer Center - Oklahoma City,
Oklahoma
 OU Health is the only clinical site that requires IRB approval, so
we will not be obtaining data from this site.

3. Will your study be prospective or retrospective?

 This study will include retrospective plans < 3 years past (2020-present)

4. Number of research samples (ex: patients or survey participants) for data collection
 10-15 HCSP Treatment patients from the two clinical sites
Data Collection Details
1. How many clinical sites will you be collecting data from?
 Two clinical sites will share former WBRT treatment plans that specifically
involve Hippocampi Sparing (HCS) techniques.

2. What information are you interested in (if a planning study, list structures for
evaluation; if a study survey, list your study questions)?
 Margins around planning target volume (PTV)
 Margins around the HC-avoidance 5mm
 % of hot spot(s) and locations
 If constraints for OAR are met
 Max dose to HC
 Number of arcs
 Couch angles
 Field design (split-x, open field)
 FFF vs FF beams
 HDMLCs vs standard MLCs

3. What are your inclusion criteria? Exclusion criteria?

 The inclusion criteria for this study will be a WBRT treatment plan, created
in Eclipse, specifically, for HCS. All other Treatment plans will be excluded.

Standard structure set:

Body
Brain
BrainStem
Couch
CTV 3000/3500
Cochlea L/R
Eye L/R
Hippocampi
HippoCampi L/R
Hippocampi +5mm
Lens (L/R)
OpticChiasm
Optic Nerve L(R)
Oral Cavity
PTV 3000
Spinal Cord
ZDose
Z Inf Avoid
 Z opti PTV
Retina L/R
Pituitary
Lacrimal L/R
Larynx

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.) 
 Having standard structure set and planning all selected studies in the same
three manners as each of the facility deems acceptable. Comparing all three
planning methods. Using the same color charting in the DVH’s for easy
comparison.
 To ensure the number of variables are limited, we plan to use patients who
have been contoured by the same dosimetrist and approved by the same
physician if possible. Then each patient will be planned with the three
different techniques. If this approach is feasible, only one clinical site will be
collecting data and that will eliminate many variables.
 Facilities will share anonymized treatment planning CT (TPCT) data sets from
patients planned to have HCS-WBRT, and all TPCT data sets will be contoured
by the same physician with the same structures, eliminating variables in
contouring differences. Each of the three planning techniques will be created on
each TPCT data set with the same optimization requests. Each plan will be
analyzed to determine which planning technique, if any, delivers the prescribed
PTV coverage, lowest dose to the hippocampi (<1600 cGy), and lowest maximum
hot spot (<110%) with considerations on length of treatment time and treatment
implementation.

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).
 The group should be advised by clinical preceptors and/or professors. This
will be addressed in the upcoming weeks. As briefly discussed, clinical sites
will share deidentified DICOM images and Eclipse HCS treatment plan, each
clinic site name will be attached to DICOM images. The first patient would be
labeled as: A01SLHS. Each clinic will maintain their own patient identifiers.
 Images and plans will be posted to a shared drive, (which will be password
protected) with the help of Medical Physics, UWLAX? and IT.

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)
 Fully anonymized data in a OneDrive folder

7. What resources (in addition to the literature search) are available for you to use?
 Knowledge of clinical staff at each of the three sites

8. Previous research study that will be used for data analysis (ex: RTOG study
constraints):
 RTOG 0933
 NRG-CC001

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)
 Allison Wright
 Data Collector(s)-someone who will be doing the data collection and data
reporting in excel; maintaining journal entries)
 All three research participants will share data from each
clinical site
 Data analysis-someone who will be responsible for analyzing the raw data,
running any statistical tests and providing conclusive data for the writer
 Kristen Eberhard
 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.
 Kearla Bentz
  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