Group 9

Michael S Wheatley

Elizabeth Mcginnis

Thomas Sutherland
DOS - 711

Research Organization Document

Phase I
In the lecture from this week, you learned about the first few essential steps to a successful
research project.
1. Select a philosophical foundation
2. Investigate a topic
a. Develop a research PROBLEM
3. Find a supporting problem/develop a theory base (literature review)
4. Develop scientific question/query and select a research design
This document will help you apply these essential steps to your capstone project.
1. What philosophical foundation are you pursuing? Why?
For this project the group will be pursuing the experimental type of philosophical
design. The nature of the research will involve strictly looking at data, dose to organ
at risk, as our determining factor for outcome of research.

2. What is your topic idea?

The group’s topic is the limiting of lumbosacral plexus (LSP) dose in pelvic with
paraaortic treatment planning cases by delineating the LSP as an organ at risk.

a. What is a problem that you can solve? Just because a topic is interesting doesn’t
mean that it is researchable. You MUST have a problem to solve. A good place to
start is to ask your clinical educators what are some problems they have
encountered in their clinics?
i. Is there routinely a dosimetric planning constraint that they can’t meet
necessitating the need to investigate a NEW way to plan that site?
Based on feedback from our clinical mentors, the LSP is not a standard organ
at risk that is routinely contoured and tracked for dose constraints.
ii. Does your clinic routinely have collision issues with the
gantry/couch/patient? Could you come up with a solution?
 iii. Did your clinic recently implement a new technology (FFF capabilities,
Vision RT, bladder scanning etc.)? Is your clinical manager seeking
feedback from staff on how the process is going?
iv. Is there a step of the radiation oncology treatment process
(referralschedulingconsultsimulationtreatment
planningtreatment) that doesn’t transition easily? Or errors occur
frequently? Could you solve this problem?

3. Find a supporting problem/develop a theory base. These concepts are combined

because both concepts support the idea that you need to determine what’s out there
on your particular topic. What knowledge exists on your topic? Conduct a literature
review on your topic. You’ve identified a problem to solve but how do you know
that someone else hasn’t already researched this problem? This is the purpose of a
literature review. You need to find peer-reviewed scholarly articles that support
the need for your proposed research. The pertinent articles that you find will be
used to confirm or refute the results of your study so the research must be current
(5 years old at the most). The only circumstance in which older articles should be
used is in the case of task group reports, QUANTEC or similar monumental articles.
List the articles that you intend to use to support your research in AMA formatting
in this document. Refer to this list often.
In researching this topic, we came across many articles looking at the need for
better dose constraints regarding LSP in pelvic cancer treatments. Most of the
research looked at dose constraints that were established for the V40 and V50
constraints that would fit our patient population.
Here are some of the articles that we used:

References

1. Vinciguerra C, Nardone V, Sicurelli F, Guida C, Cappabianca S. Lumbosacral plexopathy in

pelvic radiotherapy: An association not to be neglected; A systematic review, Arch Neurosci.
2019;6(4):1-6. http://dx.doi.org/10.5812/ans.86686

2. Min M, Roos D, Keating E, et al. External validation of the lumbosacral plexus-contouring

protocol developed by Yi et al. (IJROBP 2012; 84: 376-82) for pelvic malignancies. J Med
Imaging  Radiat Oncol. 2014;58:117-124. http://dx.doi.org/10.111/1754-9485.12106
3. Tunio M, Al Asiri M, Bayoumi Y, et al. Lumbosacral plexus delineation, dose distribution,
and its correlation with radiation-induced lumbosacral plexopathy in cervical cancer
patients. Onco Targets  Ther.  2015;8:21-27. http://dx.doi.org/10.2147/OTT.S71086

4. Delanian S, Lefaix J, Pradat P. Radiation-induced neuropathy in cancer survivors. Radiat

Oncol. 2012;105(3):273-282. http://dx.doi.org/10.1016/j.radonc.2012.10.012

5. Yi S, Mak W, Yang C, et al. Development of a standardized method for contouring the

lumbosacral plexus: a preliminary dosimetric analysis of this organ at risk among 15 patients
treated with intensity-modulated radiotherapy for lower gastrointestinal cancers and the
incidence of radiation-induced lumbosacral plexopathy. Int J Radiat Oncol Biol Phys.
2012;84(2):376-382. http://dx.doi.org/10.1016/j.ijrobp.2011.11.074

6. Bourhafour I, Benoulaid M, El Kacemi H, El Majjaoui S, Kebdani T, Benjaafar N.

Lumbosacral plexopathy: A rare long-term complication of concomitant chemo-radiation for
cervical cancer. Gynecol Oncol Res Pract. 2015;2(12):1-4. http://dx.doi.org/10.1186/s40661-
015-0019-9

4. What are your supporting questions? Develop some key questions that your reader
will know the answer too after reading your research paper that support your
research question. These questions should require elaboration (a simply stated
yes/no answer question is not permitted). For example:
a. Research Question: Where should our next coffee shop location be?
b. Supporting Questions: What customer base are we seeking?

Supporting questions would be:

Can volumetric constraints of V40 and V50 be met for the LSP while still providing an
optimal treatment plan to the target volume?

Will delineation of the LSP as an organ at risk become a standard part of VMAT planning to
prevent unwanted dose to that region?

5. What type of research design are you interested in pursuing with this topic? Some
very basic information on each type (experimental/quantitative or
 naturalistic/qualitative) was provided at the end of this week’s lecture. You will get
more into the research design in the coming weeks but you should determine which
design you are going to pursue now.
For this research it will be done using experimental/quantitative design. Our goal is
to review pelvic with paraaortic cancer cases where the LSP was not previously
identified and to retrospectively contour the LSP to track the volumetric doses.
These patients will then be re planned to see if volumetric recommendations can be
met without jeopardizing the original target volumes. (preventing inadvertent dose
dumping in the region).

Remember that the purpose of this document is to brainstorm ideas. You will post answers to
these questions in the private discussion forum for your group. The instructors and advisors will
then review your posts and give you direction on topics that you are seeking.

Research Organization Document

Phase II
Group 9
Liz McGinnis
Thomas Sutherland
Michael Wheatley
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?
For this research project our group will be pursuing a quantitative experimental
research design, as we will mainly be looking at experimental data to draw from.
 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.

IRB approval will not be needed as all research will involve anonymous patient
identifiers and will not present any personal health information. Group members are Liz
Mcginnis, Thomas Sutherland, and Michael Wheatley
3. Will your study be prospective or retrospective?

We will look at cases retrospectively. It will involve comparing pelvic treatment plans
containing para-aortic volumes and determining dose that the lumbo-sacral plexus
received. Then these same plans will be re-planned to try and meet limiting dose
objectives to the LSP.

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

To be decided.

Data Collection Details

1. How many clinical sites will you be collecting data from?
Two centers will be used for data collection. Ascension All Saints Cancer Center and The
James Graham Brown Cancer Center will be the sites that Thomas and Michael will be
doing the contouring of LSP and retrospective VMAT planning.

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 if limiting volumetric dose to the Lumbo-Sacral Plexus could be used
as a planning constraint to prevent sacral plexopathies in patients receiving pelvic and
para-aortic radiation courses of therapy.

3. What are your inclusion criteria? Exclusion criteria?

We are going to limit our patients that were planned with volumetric arc therapy only as
our base line comparison study. These patients will be primary pelvic cases that
included para-aortic nodal irradiation. By only including this treatment technique we
hope to have a better comparison. We will exclude all other treatment techniques such
as 3D conformal.
 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.)

Patients will be selected with the same total dose prescriptions and same treatment
planning technique (VMAT). The contouring of the LSP will be standardized to be
consistent across the two clinical sites.

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).

We will use an alphanumeric system: 1-50P (P=Patient) correlates numerically with 1-

50V (V=VMAT)

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)

Spreadsheet in OneDrive with access only to group members and research instructors.

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

Planning data outcomes

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

Planning data outcomes

Group Roles
Roles of each group member (members may have multiple roles)

Liz McGinnis: Author/Data Analysis

Thomas Sutherland: Data Collector/Editor

Michael Wheatley: Data Collector/Editor

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).

The project template our group will be following is a research project template with quasi-
experimental design. We will have control and manipulation of the comparison plans and have
the best chance to witness results without the need for randomization using a sample size of 20
to 30 patients.