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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?
- Experimental/Quantitative (gathering data, comparing coverage and doses to
OAR)

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.
- Benjamin, Carli, Cory

3. Will your study be prospective or retrospective?


- Prospective

4. Number of research samples (ex: patients or survey participants) for data collection
- 19
Data Collection Details
1. How many clinical sites will you be collecting data from?
- 1, Carli from the Huntsman Cancer Institute

2. What information are you interested in (if a planning study, list structures for
evaluation; if a study survey, list your study questions)?
- Uncertainty parameters for setup tolerances on DIBH EZFluence plans and their
effect on PTV coverage as well as OAR dose (structures for evaluation: heart and
breast PTV)

3. What are your inclusion criteria? Exclusion criteria?


- Inclusion: DIBH left sided breast treatments. Hypofractionated 9 day treatment
course (All patients were included in the November Protocol Clinical Trial).
 November Protocol Eligibility Criteria (only criteria that affect this study
are listed):
- Histologically confirmed invasive carcinoma and/or Ductal
Carcinoma In Situ (DCIS) of the breast.
- Final pathologic Tis, T1-T3, all must be N0 and M0 status.
- Negative inked histologic margins from lumpectomy, with the
exception of a focus of positive margin at the pectoralis fascia.
- Radiation oncologist does not plan to treat regional lymph nodes
beyond standard whole breast tangent fields.
- Lumpectomy with negative lymph node on surgical evaluation
(Isolated tumor cells in lymph nodes will be permitted). Patients
with invasive carcinoma ≥ 70 yrs and with ER+ positive tumor ≤
2.0cm may enroll without surgical lymph node evaluation, per
section 5.1. Patients with Ductal Carcinoma In Situ (DCIS) of the
breast only may enroll without surgical lymph node evaluation.
- ECOG (Zubrod) Performance Status 0-1.
- Patient ≥ 18 years of age.
- Exclusion: Unqualified candidates for DIBH or ineligibility for the November
Protocol.

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.)
- Carli is collecting data at her center, Ben is conducting analysis, Cory will write
the paper with the help of the others in editing.

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).
- Spreadsheet with names, EMRs, and any other personal information omitted

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)
- Carli is recording all data into a spreadsheet. The group will keep the
spreadsheet saved in OneDrive.

7. What resources (in addition to the literature search) are available for you to use?
- Dosimetrists and physicists within each clinic. More?

8. Previous research study that will be used for data analysis (ex: RTOG study
constraints):
- November Protocol Clinical Trial 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)
- Ben/Carli
Data Collector(s)-someone who will be doing the data collection and data
reporting in excel; maintaining journal entries)
- Carli
Data analysis-someone who will be responsible for analyzing the raw data,
running any statistical tests and providing conclusive data for the writer
- Ben
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.
- Cory
Editor This should be ALL group members except the writer
- Ben and Carli

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

- Quantitative (differences in coverage of breast volume and dose to organs at


risk)
- Randomization- coin flip or computer program that arbitrarily separates two
groups
- Control group (no uncertainty parameter used in plans)
- Manipulation of independent variable- uncertainty parameter used for
EZFluence plans

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