Research Organization Document

Phase II
The next section of your research organization document contains the specifics to
your research design. Please use a different color ink to answer the questions below.
Remember to answer these questions in the discussion forum for feedback from the
instructors. You will turn in Phase I and Phase II of the Research Organization Document at
the end of this module. Please note that you cannot move forward with your data collection
until after your topic is approved.

Basic Study Components

1. What research design are you pursuing?

We are pursuing a quantitative/experimental 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.
Yes, we will need IRB approval. Group members are Rob Rohe and Lauren Wilson.
3. Will your study be prospective or retrospective?
Our Study will be retrospective. We plan on creating treatment plans on past
patients treated for breast cancer in the prone position.

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

Right now we are looking at 16 patients. As more patients come in we can include
them in our research project. We aim for a sample size of 20 patients.

Data Collection Details

1. How many clinical sites will you be collecting data from?

The only site we will be collecting data from one clinical site.

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

The structures we will be evaluating will be the PTV, CTV, Heart, and Lungs. We will
aim to keep metrics within 2% of the original plan. We will also be evaluating
isocenter position.

3. What are your inclusion criteria? Exclusion criteria?

 The inclusion criteria for our study include: The patient must have been treated at
UFHPTI for breast cancer. The patient must have been treated in the prone position.
The patient must have been treated on Truebeam linear accelerator.

Exclusion criteria for our study include: Patient must have been treated on Civco
Horizon immobilization device. Patient’s treatment must not have included regional
lymph nodes.

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.)

Only one group member will be doing the planning. Our group will be focusing on
patients treated only on the Truebeam linear accelerator positioned with the Civco
Horizon immobilization device.

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).

Plans created can be anonymized in RayStation. Both members of our group are at
the same clinical site and will have access to the plans without transferring data
sets.

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)

Our group will be recording data in a folder on a UFHPTI network drive. Both
members will have access to this folder, but it will not be accessible outside of the
clinic.

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

Our group will have access to the treatment plans of patients involved in our
research. Also we will have access to the treatment machine and immobilization
used for treatment. Current policies and procedures regarding isocenter placement
and simulation are also available.
 8. Previous research study that will be used for data analysis (ex: RTOG study
constraints):

Research studies that will be used by our group for data analysis include: RTOG
1005, NSABP B-39, and RTOG 0413.

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.

Group Leader: Lauren Wilson

Data Collector: Robert Rohe
Data Analysis: Robert Rohe
Writer: Lauren Wilson
Editor: Robert Rohe

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

The template our group will be following is the research paper template.