Prospective, Randomized Evaluation of Patient Reported Knowledge and Satisfaction Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational Video
Phase: NA
Conditions: Cervical Cancer, Uterine Cancer
Sponsor: University of California, San Diego

Prospective, Randomized Evaluation of Patient Reported 
Knowledge and Satisfaction Following the Use of an 
Enhanced Gynecologic Brachytherapy-Specific 
Educational Video 
NCT04363957
Document Date: 1/18/2019 

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Prospective, Randomized Evaluation of Patient Reported Knowledge and Satisfaction 
Following the Use of an Enhanced Gynecologic Brachytherapy-Specific Educational 
Video 
Principal Investigator 
Jyoti Mayadev 
Associate Professor 
Director of Gynecologic Brachytherapy  
Chief, Gynecology Oncology Radiation Services 
University of California, San Diego 
3855 Health Sciences Drive 
La Jolla, CA 92093 
Ph: 858.822.4364  Fax: 858.246.1505  
Study Agent: 
Brachytherapy video consent 
Protocol 
Date 
Original (v 1.0) 
18Jan2019 

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LIST OF INVESTIGATORS 
 
 
PRINCIPAL INVESTIGATOR 
Jyoti Mayadev, MD 
Associate Professor 
Director of Gynecologic Brachytherapy  
University of California, San Diego 
3855 Health Sciences Drive 
La Jolla, CA 92093 
Ph: 858-822-4364   
Fax: 858-246-1505 
jmayadev@ucds.edu 
 
CO-INVESTIGATOR(S) 
Arno J. Mundt MD 
Chair 
University of California, San Diego 
3855 Health Sciences Drive 
La Jolla, CA 92093 
Ph: 858-822-4364   
Fax: 858-246-1505 
amundt@ucds.edu 
 
Michael McHale MD 
Professor 
Gynecology Oncology  
University of California, San Diego 
3855 Health Sciences Drive 
La Jolla, CA 92093 
Ph: 858-822-4364   
Fax: 858-246-1505 
mtmchale@ucsd.edu 
 
Ramez Eskander MD 
Assistant Professor 
Gynecology Oncology  
University of California, San Diego 
3855 Health Sciences Drive 
La Jolla, CA 92093 
Ph: 858-822-4364   
Fax: 858-246-1505 
reskander@ucsd.edu 
 
Derek Brown 
Associate Professor MD 
University of California, San Diego 
3855 Health Sciences Drive 
La Jolla, CA 92093 
Ph: 858-822-4364   

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Fax: 858-246-1505 
D7brown@ucsd.edu 
 
Christine Feng MD 
Radiation Medicine Resident Physician  
University of California, San Diego 
3855 Health Sciences Drive 
La Jolla, CA 92093 
Ph: 858-822-4364   
Fax: 858-246-1505 
chf013@ucsd.edu 
 
Dominique Rash MD  
Assistant Professor 
University of California, San Diego 
3855 Health Sciences Drive 
La Jolla, CA 92093 
Ph: 858-822-4364   
Fax: 858-246-1505 
drash@ucsd.edu 
 
BIOSTATISTICIAN 
Jing Zhang, MSc 
Statistician 
Moores Cancer Center 
Biostatistics Shared Resources 
University of California, San Diego 
La Jolla, CA 92093 
(858) 534-2098 
 
 
 
 

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Signature Page 
 
 
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations and ICH guidelines. 
 
 
 
UCSD Principal Investigator / Study Chair 
 
Jyoti S. Mayadev 
_____________________________ 
Printed Name 
 
 
 
 
 
 
 
2/6/2018 
_____________________________  
____________________ 
Signature 
 
 
 
 
Date 
 
 
 
 
 
 

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TABLE OF CONTENTS 
1.0 
BACKGROUND AND RATIONALE ........................................................................................... 11 
1.1 
Background ................................................................................................................................. 11 
1.2 
Study Intervention ....................................................................................................................... 11 
1.3 
Rationale ..................................................................................................................................... 11 
2.0 
STUDY OBJECTIVES ................................................................................................................ 11 
2.1 
Primary Objectives ...................................................................................................................... 12 
2.2 
Secondary Objectives ................................................................... Error! Bookmark not defined. 
 
 .................................................................................................................................................... 12 
3.0 
PATIENT ELIGIBILITY ............................................................................................................... 12 
3.1 
Inclusion Criteria ......................................................................................................................... 12 
3.2 
Exclusion Criteria ........................................................................................................................ 13 
4.0 
TREATMENT PLAN ................................................................................................................... 13 
4.1 
Study Design ............................................................................................................................... 14 
 
4.2 
Duration of Study Treatment ....................................................................................................... 14 
4.3 
Duration of Follow Up ................................................................................................................. 14 
5MEASUREMENT OF EFFECT ................................................................................................................. 14 
5.1Brachytherapy-specific outcomes ...................................................................................................... 14 
6 
ADVERSE EVENTS ................................................................................................................... 14 
7.0 
AGENT INFORMATION .................................................. ERROR! BOOKMARK NOT DEFINED. 
7.1 
Gynecologic Brachytherapy Video Consent ............................................................................... 14 
8.0 
STATISTICAL CONSIDERATIONS ........................................................................................... 15 
8.1 
Study Design/Study Endpoints ................................................................................................... 15 
8.2 
Sample Size and Accrual ............................................................................................................ 15 
8.3 
Evaluable Subjects and Subject Replacement ........................................................................... 16 
8.4 
Data Analyses Plans ................................................................................................................... 16 
9.0 ............................................................................................................................................................... 17 
9.1 
STUDY MANAGEMENT ............................................................................................................. 17 
9.2 
Conflict of Interest ....................................................................................................................... 17 
9.3 
Institutional Review Board (IRB) Approval and Consent ............................................................ 17 
9.4 
Subject Data Protection .............................................................................................................. 17 
9.5 
Data and Safety Monitoring/Auditing .......................................................................................... 17 
9.6 
Adherence to the Protocol .......................................................................................................... 18 
9.7 
Amendments to the Protocol ....................................................................................................... 18 
9.8 
Record Retention ........................................................................................................................ 18 
9.9 
Obligations of Investigators ......................................................................................................... 18 
10.0 
REFERENCES ........................................................................................................................... 20 
11.0 
APPENDICES ............................................................................................................................. 21 
Appendix A. Performance Status ............................................................................................................ 21 
  Appendix B.  NCCN Distress Tool…………………………………………………………………21 
Appendix C.  Patient Reported Satisfaction ……………………………………………………….22 

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LIST OF ABBREVIATIONS 
 
AE 
Adverse Event 
CTCAE 
Common Terminology Criteria for Adverse Events 
ECOG 
Eastern Cooperative Oncology Group 
HIPAA 
Health Insurance Portability and Accountability Act 
HPV 
Human Papillomavirus 
IRB 
Institutional Review Board 
NCI 
National Cancer Institute 
 

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STUDY SCHEMA 
 
 
 
 
Any patient with gynecologic cancer 
who is deemed to require a 
brachytherapy procedure, and is 
willing to participate is eligible for 
inclusion. 
(n=80)
(n=40)
Standard 
clinical 
consent
Data 
collection*
No further 
education 
Data 
collection*
Brachytherapy 
implants
Data 
collection*
(n=40)
Standard 
clincal 
consent
Data 
collection*
Brachytehrapy 
video intervention  
via UC Radiation 
Learning Website
Data 
collection*
Brachythera
py implants
Data 
collection*
Arm A
Arm B
*Data collection. Prospective data collection includes: age, performance status, TMN staging, tumor histology, use and type of systemic 
therapy, brachytherapy dose volume histogram information, treatment-specific dosimetric and quality assurance information. Validated 
data includes: NCCN distress score, and brachytherapy-specific survey [3].  
 

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STUDY SUMMARY 
Title 
Prospective, Randomized Evaluation of Patient Reported 
Knowledge and Satisfaction Following the Use of an Enhanced 
Gynecologic Brachytherapy-Specific Educational Consent Video. 
Short Title 
Brachytherapy video consent 
Phase 
Phase III 
Methodology 
Randomized 
Study Duration 
12 months 
Study Center(s) 
Single-center 
Objectives 
Primary Objective:  To evaluate the impact of a gynecologic 
brachytherapy-specific educational consent video in patients 
receiving brachytherapy on patient reported satisfaction  
Secondary Objectives: Evaluate the integration of the 
brachytherapy-specific consent video on patient treatment-related 
anxiety 
Number of Subjects 
80 
Diagnosis and Main 
Inclusion Criteria 
Any patient with gynecologic cancer who is deemed to require a 
brachytherapy procedure, and is willing to participate is eligible for 
inclusion.  
Study Product(s), Dose, 
Route, Regimen 
Gynecologic brachytherapy video consent. 
Duration of 
administration 
Prior to consent for the gynecologic brachytherapy procedure. 
Reference therapy 
None. 
Statistical Methodology 
1:1 block randomization between standard and enhanced video 
consent. To address the study hypotheses, we will use two- 
sample t-test to compare satisfaction score in two groups (patients 
provided with standard of care verbal consent (arm A) vs. 
enhanced online accessible brachytherapy educational video 
(Arm B)). 
 

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STUDY TABLE  
 
Consult 
Pre-Informed 
consent 
Intervention 
Post Informed 
Consent 
Post Brachytherapy 
History (Medical/Oncology) 
X 
Demographics 
X 
Eligibility criteria 
X 
Physical exam 
X 
Vital Signs 
X 
Height, weight 
X 
Performance status 
X 
TNM stage 
X 
Tumor histology 
X 
Use/type of systemic therapy 
X 
Brachytherapy dose/volume information 
X 
Physician workflow data 
X 
Informed Consent 
A, B 
NCCN distress score 
X 
X 
X 
Brachytherapy-specific survey 
X 
X 
X 
Brachytherapy educational video  
B 
Arm A: Standard consent process 
Arm B: Video consent process 

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1.0 
BACKGROUND AND RATIONALE 
 
Background 
 
High dose-rate brachytherapy is a highly technical and integral component of the 
definitive treatment of gynecologic cancers. Gynecologic brachytherapy requires a skillfully 
coordinated team approach with a focus on the patient experience1.   
 
 
  
 
 
Patients associate high-quality care with the ability to participate in decision making and 
obtain reliable information about their health and treatment 3,4.   
 
 
 
Provider explanation of these complex information processes can be overwhelming 
despite a well-documented informed consent 9.  Prior work from our group explored enhanced 
patient consent material on gynecologic brachytherapy understanding and patient satisfaction 
and quality of life (rash Mayadev).  We found that brachytherapy specific take home materials in 
supplement to a standard verbal consent process resulted in high patient treated related 
satisfaction (Rash D, Mayadev, J.  Prospective Evaluation of Patient Satisfaction Following the 
Use of Visual Brachytherapy-Specific Educational Materials for Cervical Cancer. Brachytherapy. 
2016 Jan-Feb;15(1):65-70. doi: 10.1016/j.brachy.2015.09.007).   
 
 
This study seeks to engage and educate the patient regarding the expected treatment 
trajectory using audiovisual mixed multimedia that comprehensively discusses the entire 
brachytherapy procedural process. We hypothesize there will be a significant improvement in all 
evaluable metrics in the cohort of patients receiving the brachytherapy video which would 
translate into improved quality of delivered care, patient understanding, increased treatment 
compliance, and enhancement in provider-patient communication. 
 
 
Study Intervention  
This study uses a gynecologic brachytherapy specific patient education video for the consent 
process in radiation oncology.  All patients will meet with the radiation oncologist and have the 
standard of care procedure consent performed.  Arm B (intervention arm) will have the access 
to view the brachytherapy educational video via the UCSD radiation learning center 
(https://ucsd.radonclearningcenter.org/ucsdradonclearningcenter) after the standard consent, 
study consent, and prior to the first brachytherapy procedure.   
 
 
Rationale 
 
Brachytherapy is a highly technical and integral component of the definitive treatment of 
gynecologic cancers [1]. To enhance provider communication and patient engagement, our 
study investigates a video consent on impact of patient treatment-related outcomes. 
 
 
 
We will use a detailed brachytherapy video in addition to the standard brachytherapy 
verbal consent to evaluate patient-reported satisfaction and patient anxietyfor gynecologic high-
dose rate brachytherapy (a radiation procedure).  
2.0 
STUDY OBJECTIVES 

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Primary Objectives 
To evaluate the impact of a gynecologic brachytherapy-specific educational video in patients 
receiving brachytherapy on patient reported satisfaction  
 
Secondary Objectives 
 To evaluate the use of the brachytherapy-specific educational video on patient treatment-
related anxiety 
 
 
Exploratory Objectives 
      To evaluate the number of views and completeness of views of the brachytherapy video by 
the patients.  To examine the patient radiation doses, treatment planning aspects, and normal 
tissue doses on brachytherapy completion. 
 
 
Endpoints: 
2.4.1 Primary: 
Using the brachytherapy specific questionnaire, we will collect three patient reported time points 
for impact: baseline, after the consent process and before the first brachytherapy procedure 
(both arms have the standard consent at the consultation, and arm B will have access to the 
brachytherapy video online), and prior to the last brachytherapy procedure. For primary 
outcome we will examine satisfactory scores assessed by the brachytherapy-specific survey at 
two time points: baseline and following consent. 
2.4.2 Secondary: 
We will examine satisfactory scores at three patient reported time points: baseline, after the 
consent process and before the first brachytherapy procedure, and prior to the last 
brachytherapy procedure.   
 
Using the NCCN distress scale, we will examine patient treatment-related anxiety at three 
patient reported time points: baseline, after the consent process and first brachytherapy 
procedure, and prior to the last brachytherapy procedure.   
 
 
2.4.3 Exploratory: 
The view number and completeness will be recorded from the UCSD radiation oncology 
learning website.  The dose distribution of the target volume, normal tissue volumes and 
doses, and treatment planning goals will be explored. 
 
3.0 
PATIENT ELIGIBILITY 
 
Inclusion Criteria 
 
Subjects must meet all of the inclusion criteria to participate in this study. 
 
1. Patient has the ability to understand and the willingness to sign a written informed 
consent. 

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2. Patient must be female, all races and ethnic groups are eligible. 
 
3. Must be > 18 years of age, or have parental approval for inclusion. 
 
4. Must carry a diagnosis of gynecologic malignancy.  
 
5. Is deemed to require high-dose rate gynecologic brachytherapy procedure (intracavitary, 
hybrid intracavitary/interstitial, or interstitial). 
 
6. Any prior external beam radiation therapy is allowed.  
 
7. Any performance status is allowed.  
 
8. Women of child-bearing potential and men with partners of child-bearing potential must 
agree to use adequate contraception (hormonal or barrier method of birth control; 
abstinence) prior to study entry, for the duration of study participation, and for # days 
following completion of therapy.  Should a woman become pregnant or suspect she is 
pregnant while participating in this study, she should inform her treating physician 
immediately. 
• 
A woman of child-bearing potential is any female (regardless of sexual orientation, 
having undergone a tubal ligation, or remaining celibate by choice) who meets the 
following criteria: 
o Has not undergone a hysterectomy or bilateral oophorectomy; or 
o Has not been naturally postmenopausal for at least 12 consecutive months 
(i.e., has had menses at any time in the preceding 12 consecutive months) 
 
Exclusion Criteria 
 
Subjects meeting any of the exclusion criteria at baseline will be excluded from study 
participation. 
 
1. Patient has had prior high-dose rate gynecologic brachytherapy at any point in the past.  
2. . Patient is a non English speaker  
 
3. Patient is unable to watch the video 
 
4. Patient declines consent to the study  
 
5. Study-specific exclusion criteria. 
 
6. Patient has a severe or uncontrolled medical disorder that would, in the investigator’s 
opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic 
renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric 
illness/social situations that would limit compliance with study requirements). 
 
4.0 
TREATMENT PLAN 

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Study Design 
1:1 randomized trial using blocked randomization based on chronologic arrival in clinic, a group 
of patients will be randomized to the standard of care verbal consent (Arm A), or the standard of 
care consent plus the online brachytherapy informed video (Arm B). There will be three time 
points for the collection: After the standard consent process as the baseline, following the 
standard only vs standard and educational video consent process prior to the first 
brachytherapy procedure, and prior to the last brachytherapy procedure. The patients in the 
brachytherapy video consent process will be watching this online via the UCSD Radiation 
Oncology Learning Center Website 
https://ucsd.radonclearningcenter.org/ucsdradonclearningcenter.  The patient will be given a 
specific log in to use, and we will be able to track the number of times the patient watches the 
video and the completion of the video view.  The patient is allowed to watch the video as many 
times as desired. 
 
Duration of Study Treatment 
In the absence of treatment delays, the treatment will continue through the end of the 
completion of the necessary external beam radiation therapy treatments, or conclusion of all 
gynecologic brachytherapy procedures.  
 
Duration of Follow Up 
The study intervention with conclude after completion of the final brachytherapy implantation 
and prior to discharge from clinic.  
 
Discontinuation from Study Participation 
Patients may be removed from study participation for the following reasons (in addition to those 
listed for discontinuation of study treatment): 
• 
The patient or legal representative withdraws consent; 
• 
The patient is lost to follow-up; 
• 
The patient dies; 
• 
It is the decision of the investigator. 
5.0 
Measurement of Effect 
 
Brachytherapy-specific outcomes 
Primary outcome of this trial will be change in patient satisfaction scores (difference of baseline 
and following the video consent) as assessed by the brachytherapy-specific survey. Secondary 
outcomes will include patient treatment-related anxiety(NCCN distress score).  
6.0 
ADVERSE EVENTS 
 
An adverse event (AE) is any untoward medical occurrence in a patient 
receiving study treatment and which does not necessarily have a causal 
relationship with this treatment. We do not anticipate AE on this video 
study.  Gynecologic Brachytherapy Video Consent 
 
7.  Product description:   
 
We developed a novel gynecologic brachytherapy-specific video. Due to clinical time 
constraints, it is often not feasible to comprehensively cover the full expanse of a brachytherapy 

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procedure with the patient; however, this is a crucial part of the treatment process. The video 
and associated multimedia educational materials will be used to enhance patient education and 
understanding, and provider-patient communication. 
 
Video weblink: https://chtapps-
prod.ucdmc.ucdavis.edu//VideoConf/VCVideo/BRACHYSixthCut.mp4 will be posted to the 
UCSD Radiation Oncology Learning Center Website 
https://ucsd.radonclearningcenter.org/ucsdradonclearningcenter 
 
Availability: Supplied by UCSD PI, Dr. Jyoti S. Mayadev. 
 
How supplied: Audiovisual digital multimedia.  
 
Storage and stability: On UCSD computing devices, behind institutional firewall, and subject to 
computing and technology requirements. 
 
Route of administration for this study: Patient views video prior to gynecologic 
brachytherapy. 
 
Side effects: There are no anticipated side effects. 
 
8.0 SAMPLE SIZE AND STATISTICAL PLAN 
This is a single site, randomized, open-label trial comparing the effect of the 
branchytherapy specific video  versus verbal standard consent in patients receiving 
gynecologic brachytherapy(N=80).  
8.1 
Study Design/Study Endpoints 
In this open-label study design, eligible participants will be randomized using a simple  1:1 
schedule to either brachytherapy verbal standard consent (Arm A), or the brachytherapy specific 
video (Arm B),  based on chronological arrival in clinic. There will be three time points for the 
collection: after the standard verbal consent process at baseline, following the standard vs video 
brachytherapy education, and prior to the last brachytherapy procedure. 
 
Primary outcomes will be judged from a Likert-scale questionnaire. Patients will be given a 
Likert-scale questionnaire to assess their satisfaction with the information provided about the 
brachytherapy procedure which was adapted from a previously-published, validated instrument, 
and was published by our brachytherapy group2 . We will also assess the reduction in 
procedure-related anxiety based on the video intervention using the validated National 
Comprehensive Cancer Network patient anxiety screening tool.  
 
8.2 Power and Sample Size Determination 
 
 
 

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Study Power: Estimates of study power are based on two-sample t-tests comparing outcomes 
between patients provided with brachytherapy informed video  versus standard of care verbal 
consent. We based power estimates on a sample-size of 80 participants (40 pts with 
brachytherapy informed video  and 40 with standard of care verbal consent). We used PASS 14 
(NCSS Statistical Software). Assuming a two-sided test with alpha=0.05, we have 80% power to 
detect a 3.2 mean difference between armse.g., 57.5 mean score in patients with brachytherapy 
informed video versus a 54.3 mean score in patients with standard of care verbal consent, 
assuming SD of 2.7 and 6.4, respectively. 
 
Accrual will be based on chronological arrival in clinic. Approximately 250 brachytherapy 
gynecologic procedures are performed at UCSD and collaborating sites annually. Accrual of 80 
participants could occur over 2 years.  Annual target accrual will be 40 participants per year. 
 
8.3 Evaluable Subjects and Subject Replacement 
The intent-to-treat (ITT) data set will include all eligible individuals who are randomized. 
The per-protocol (PP) data set will include all patients having completed all three data collection 
time points as assessed by the brachytherapy-specific survey, and NCCN distress score. 
 
 
Data will not be analyzed until we have reached target accrual. Given the short duration of the 
intervention to the end of treatment we do not anticipate any issues with the number of 
evaluable subjects. Should a subject withdraw an additional subject would be randomized and 
enrolled. A slight imbalance is accepted. 
8.4 Efficacy Analysis 
8.4.1 Analysis of Primary Endpoint  
The primary analysis will be based on the Intention-to-Treat population, defined as all 
individuals who were randomized to arm A or arm B. A Likert-scale questionnaire is used to 
calculate satisfaction score. 
Using the brachytherapy specific questionnaire, we will examine three patient reported time 
points for impact: baseline, after the consent process, and prior to the last brachytherapy 
procedure. For primary endpoint, we will use a two-sample t-test to compare differences of 
satisfaction scores at two time points (baseline and following consent process) between groups. 
We do not anticipate any possible confounders, if any we will include it in the secondary 
analysis. 
8.4.2 Handling of missing data 
In primary analysis, outcome values will not be imputed. Further sensitivity analysis for the 
impact of potential missing data will be conducted following study completion using multiple 
imputation analysis. 
 
8.4.3  Analysis of Secondary Endpoints 
Satisfactory scores at three time points will be analyzed using a mixed effect model for repeated 
measures (MMRM) to assess satisfactory scores trajectories between two arms. The MMRM 
model will include terms for time, consent arm, baseline score, arm-by-time interaction, baseline 
score by time interaction, plus covariates that include age, stage. Time will be treated as 
categorical.  

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If values of last two time points are similar, analysis of covariance model (ANCOVA) will be 
used to model the change in satisfactory scores. The mean of the last two time points will be 
calculated. That is, the after consent score (mean values) will be regressed upon baseline score 
and consent arms. Patient treatment-related anxiety between groups, defined as NCCN distress 
score, are also collected at three time points and will be analyzed using the same strategy. 
 
 
 
9 STUDY MANAGEMENT 
9.1 Conflict of Interest 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or 
financial gain greater than the minimum allowable by their institution, etc.) must have the conflict 
reviewed according to UCSD conflict of interest policy. 
9.2 Institutional Review Board (IRB) Approval and Consent  
The IRB should approve the consent form and protocol prior to any study-related activities.  It is 
expected that the IRB will have the proper representation and function in accordance with 
federally mandated regulations.  
 
In obtaining and documenting informed consent, the investigator should comply with the 
applicable regulatory requirement(s), and should adhere to Good Clinical Practice (GCP) and to 
ethical principles that have their origin in the Declaration of Helsinki. 
 
 
Before recruitment and enrollment onto this study, the patient will be given a full explanation of 
the study and will be given the opportunity to review the consent form. Each consent form must 
include all the relevant elements currently required by the FDA Regulations and local or state 
regulations. Once this essential information has been provided to the patient and the 
investigator is assured that the patient understands the implications of participating in the study, 
the patient will be asked to give consent to participate in the study by signing an IRB-approved 
consent form. 
 
Prior to a patient’s participation in the trial, the written informed consent form should be signed 
and personally dated by the patient and by the person who conducted the informed consent 
discussion. 
 
Any recruitment materials developed for this project will be submitted for IRB review 
prior to their use. 
 
9.3 Subject Data Protection 
In accordance with the Health Information Portability and Accountability Act (HIPAA), subjects 
who have provided written informed consent must also sign a subject authorization to release 
medical information to the study Sponsor and allow a regulatory authority, or Institutional 
Review Board access to subject’s medical information relevant to the study. 
9.4 Data and Safety Monitoring/Auditing 
In addition to adverse event monitoring and clinical oversight by Jyoti S. Mayadev, UCSD 

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principal investigator and co-investigators, quality assurance of the study will be performed by 
the UCSD Moores Cancer Center Clinical Trials Office internal monitor. Monitoring intervals will 
be dependent upon the number of patients enrolled and the complexity of the study.  
 
This study will also use the UCSD Moores Cancer Center Data Safety and Monitoring Board 
(DSMB) to provide oversight in the event that this treatment approach leads to unforeseen 
toxicities. Data from this study will be reported when<minimum annually, frequency related to 
risk; can ask for recommendations from DSMB> and will include: 
 
1) 
the protocol title, IRB protocol number, and the activation date of the study.  
2) 
the number of patients enrolled to date  
3) 
the dates of patient enrollment 
4) 
a summary of all adverse events regardless of grade and attribution   
5) 
a response evaluation for evaluable patients when available 
6) 
a summary of any recent literature that may affect the ethics of the study.  
9.5 Adherence to the Protocol 
Except for an emergency situation in which proper care for the protection, safety, and well-being 
of the study patient requires alternative treatment, investigators are required to conduct their 
research according to the plans reviewed and approved by the IRB.  
9.6 Amendments to the Protocol 
Should amendments to the protocol be required, the amendments will be originated and 
documented by the Study Chair. It should also be noted that when an amendment to the 
protocol substantially alters the study design or the potential risk to the patient, a revised 
consent form might be required.  
 
The written amendment, and if required the amended consent form, must be sent to the IRB for 
approval prior to implementation. 
9.7 Record Retention 
Study documentation includes all Case Report Forms, data correction forms or queries, source 
documents, Sponsor-Investigator correspondence, monitoring logs/letters, and regulatory 
documents (e.g., protocol and amendments, IRB correspondence and approval, signed patient 
consent forms). 
 
Source documents include all recordings of observations or notations of clinical activities and all 
reports and records necessary for the evaluation and reconstruction of the clinical research 
study. 
 
Government agency regulations and directives require that the study investigator must retain all 
study documentation pertaining to the conduct of a clinical trial. In the case of a study with a 
drug seeking regulatory approval and marketing, these documents shall be retained for at least 
two years after the last approval of marketing application in an International Conference on 
Harmonization (ICH) region. In all other cases, study documents should be kept on file until 
three years after the completion and final study report of this investigational study. 
9.8 Obligations of Investigators 
The Principal Investigator is responsible for the conduct of the clinical trial at the site in 
accordance with Title 21 of the Code of Federal Regulations and/or the Declaration of Helsinki. 

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The Principal Investigator is responsible for personally overseeing the treatment of all study 
patients. The Principal Investigator must assure that all study site personnel, including sub-
investigators and other study staff members, adhere to the study protocol and all FDA/GCP/NCI 
regulations and guidelines regarding clinical trials both during and after study completion. 
 
The Principal Investigator at each institution or site will be responsible for assuring that all the 
required data will be collected and entered onto the Case Report Forms. Periodically, 
monitoring visits will be conducted and the Principal Investigator will provide access to his/her 
original records to permit verification of proper entry of data. At the completion of the study, all 
case report forms will be reviewed by the Principal Investigator and will require his/her final 
signature to verify the accuracy of the data. 
 
 
 
 

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10.0 REFERENCES 
1. 
Mayadev J, Qi L, Lentz S, et al. Implant time and process efficiency for CT-guided high-dose-rate 
brachytherapy for cervical cancer. Brachytherapy. 2014;13(3):233-239. 
2. 
Rash D, Hess C, Lentz S, Tait L, Michaud A, Mayadev J. Prospective evaluation of patient 
satisfaction after the use of brachytherapy specific educational materials for cervical cancer. 
Brachytherapy. 2016;15(1):65-70. 
3. 
Colosia AD, Peltz G, Pohl G, et al. A review and characterization of the various perceptions of 
quality cancer care. Cancer. 2011;117(5):884-896. 
4. 
Watson DE MD, Peterson S. Patient experiences with Ambulatory Cancer Care in British 
Columbia, 2005/06. 2007; 
http://www.health.gov.bc.ca/library/publications/year/2007/OncologySurvey/UBC_OncologyRe
port.pdf. Accessed 4/11/15, 2015. 
5. 
Rainey LC. Effects of preparatory patient education for radiation oncology patients. Cancer. 
1985;56(5):1056-1061. 
6. 
van der Molen B. Relating information needs to the cancer experience: 1. Information as a key 
coping strategy. European journal of cancer care. 1999;8(4):238-244. 
7. 
Hess CB, Chen AM. Measuring psychosocial functioning in the radiation oncology clinic: a 
systematic review. Psycho-oncology. 2014;23(8):841-854. 
8. 
Dutta S, Nguyen NP, Vock J, et al. Image-guided radiotherapy and -brachytherapy for cervical 
cancer. Frontiers in oncology. 2015;5:64. 
9. 
LE L. Being informed: undergoing radiation therapy. Cancer Nursing. 2001;24(6):5. 
10. 
Jacobsen PB, Donovan KA, Trask PC, et al. Screening for psychologic distress in ambulatory 
cancer patients. Cancer. 2005;103(7):1494-1502. 
 
 
 

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11 APPENDICES 
Appendix A. Performance Status 
 
ECOG Performance Status Scale 
Karnofsky Performance Scale 
Grade 
Descriptions 
Percent 
Description 
0 
Normal activity.  Fully active, 
able to carry on all pre-
disease performance without 
restriction. 
100 
Normal, no complaints, no 
evidence of disease 
90 
Able to carry on normal 
activity; minor signs or 
symptoms of disease. 
1 
Symptoms, but ambulatory. 
Restricted in physically 
strenuous activity, but 
ambulatory and able to carry 
out work of a light or 
sedentary nature (e.g., light 
housework, office work). 
80 
Normal activity with effort; 
some signs or symptoms of 
disease. 
 
70 
Cares for self, unable to carry 
on 
normal activity or to do active 
work 
2 
In bed < 50% of the time. 
Ambulatory and capable of 
all self-care, but unable to 
carry out any work activities.  
Up and about more than 
50% of waking hours. 
60 
Requires occasional 
assistance, but is able to care 
for most of his/her needs. 
50 
Requires considerable 
assistance and frequent 
medical care 
3 
In bed > 50% of the time.  
Capable of only limited self-
care, confined to bed or 
chair more than 50% of 
waking hours 
40 
Disabled, requires special 
care and assistance. 
30 
Severely disabled, 
hospitalization indicated.  
Death not imminent 
4 
100% bedridden.  
Completely disabled.  
Cannot carry on any self-
care.  Totally confined to bed 
or chair 
20 
Very sick, hospitalization 
indicated. Death not imminent. 
10 
Moribund, fatal processes 
progressing rapidly 
5 
Dead. 
0 
Dead. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix B.  NCCN Distress Tool 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix C.  Patient Reported Satisfaction