Comparative Effectiveness of Interventions to Increase Guideline-based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors
Phase: NA
Conditions: Breast Cancer, Ovarian Cancer
Sponsor: Rutgers, The State University of New Jersey

 
 
 
 
 
 
 
 
 
Genetic Risk Assessment for Cancer Education and Empowerment Project (GRACE) 
NCT03326713 
November 6th, 2024 
 
 

 
 
 
Protocol Number: 2018001350 
PI Name: Kinney 
Protocol Title: GRACE Project 
V8 11/6/2024 
 
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NON-INTERVENTIONAL/METHODOLOGICAL  
RESEARCH PROTOCOL TEMPLATE 
(HRP-503b) 
 
 
 
STUDY INFORMATION 
 
Title of Project: The Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project 
 
Principal Investigator: 
 
 
Anita Kinney, PhD   
Rutgers Cancer Institute of New Jersey 
195 Little Albany Street 
New Brunswick, NJ 08901 
Telephone: (732) 235-8871 
Email: anita.kinney@rutgers.edu 
 
Subinvestigators:  
Antoinette Stroup, PhD 
 
Director, Cancer Surveillance Research Program, Rutgers Cancer Institute 
 
 
 
 
Cancer Epidemiology Services, New Jersey State Cancer Registry, NJDOH 
Lisa E. Paddock, PhD, MPH 
Deputy Director, Cancer Surveillance Research Program, Rutgers Cancer Institute 
 
 
 
 
Cancer Epidemiology Services, New Jersey State Cancer Registry, NJDOH 
 
Jie Li, MPH 
 
 
Research Scientist, Cancer Epidemiology Services, NJSCR, NJDOH 
 
Natalia Herman, MPH 
 
Research Teaching Specialist, Cancer Surveillance Research Program, RCINJ 
 
PROTOCOL VERSION NUMBER AND DATE: Version 8 11/6/2024 
 
 
 
 
 
 
 
 
 
 

 
 
 
Protocol Number: 2018001350 
PI Name: Kinney 
Protocol Title: GRACE Project 
V8 11/6/2024 
 
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Table of Contents  
Skip To Section: Hold CTRL + Click (Below) To Follow Link in Blue
 
1.0 
Research Design 
 
1.1 
Purpose/Specific Aims 
 
1.2 
Research Significance 
 
1.3 
Research Design and Methods 
 
1.4 
Preliminary Data 
 
1.5 
Sample Size Justification 
 
1.6 
Study Variables 
 
1.7 
Specimen Collection As A Primary Source 
 
1.8 
Interviews, Focus Groups, or Surveys and/or Observations 
 
 
2.0 
Project Management 
 
2.1 
Research Staff and Qualifications 
 
2.2 
Resources Available 
 
2.3 
Research Sites 
 
 
3.0 
Multi-Site Research Communication & Coordination 
 
3.1 
Non-Rutgers Research Sites 
 
 
4.0 
Research Data Source/s 
 
4.1 
Primary Data – Subjects and Specimens 
 
4.2 
Subject Selection and Enrollment Considerations 
 
4.3 
Subject Randomization 
 
4.4 
Secondary Subjects 
 
4.5 
Number of Subjects 
 
4.6 
Consent Procedures 
 
4.7 
Special Consent Populations 
 
4.8 
Economic Burden and/or Compensation 
 
4.9 
Risks and Benefits to Subjects 
 
4.10 
Secondary Data – Record/Chart Reviews, Databases, Tissue Banks, Etc. 
 
4.11 
Chart/Record Review Selection 
 
4.12 
Secondary Specimen Collection 
 
 
5.0 
Special Considerations 
 
5.1 
Health Insurance Portability and Accountability Act (HIPAA) 
 
5.2 
Family Educational Rights and Privacy Act (FERPA) 
 
5.3 
NJ Access to Medical Research Act 
 
5.4 
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
 
 
6.0 
Research Data Protection and Reporting 
 
6.1 
Data Management and Confidentiality 
 
6.2 
Data Security 
 
6.3 
Data and Safety Monitoring 
 
6.4 
Reporting Results 
 
 
7.0 
Data and/or Specimen Banking 
 
 
8.0 
Other Approvals/Authorizations 
 
 
9.0 
Bibliography 
 
 
 
 
 
 

 
 
 
Protocol Number: 2018001350 
PI Name: Kinney 
Protocol Title: GRACE Project 
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1.0 Research Design 
 
1.1 Purpose/Specific Aims  
The primary purpose of this study is to compare the effectiveness of a usual care (UC) vs. targeted generic print 
(TP) vs. tailored telephone counseling and navigation intervention (TCN) on cancer genetic risk assessment (CGRA) 
uptake at 6 months for hereditary breast and ovarian cancer (HBOC).  Secondary purposes are: 1) to compare the 
effectiveness of a TP vs. a TCN intervention vs. UC on CGRA uptake at 12 months, after removal of key access 
barriers; 2) to compare uptake of genetic testing for HBOC across the three study arms at 6 and 12 months; 3) to 
compare cognitive (beliefs, attitudes, and knowledge) and affective (distress, stress, fear) intermediate endpoints 
among women in the three study arms and explore potential underlying theoretical mediating and moderating 
mechanisms that will further specify and elucidate significant intervention effects; and 4) to perform an economic 
evaluation alongside this randomized controlled trial to estimate the cost effectiveness of the two interventions 
compared to each other and usual care, for uptake of CGRA services from the societal and payer perspectives.  
 
The New Jersey State Cancer Registry (NJSCR) will collaborate with investigators from the state cancer registries 
of Colorado and New Mexico (Dr. Anita Kinney = overall Principal Investigator) to identify women recently 
diagnosed with high-risk breast and ovarian cancer. The NJSCR will (a) recruit and consent New Jersey patients 
who are eligible to participate in the study, and (b) securely send contact and cancer-related information to the 
overall PI for women who consent so that they can be enrolled onto study by the overall PI.  This application is 
for case ascertainment using the NJCSR. 
 
A. Objectives  
AIM 1: Compare the effectiveness of a TP vs. a TCN intervention vs. UC on CGRA uptake 6 months (primary 
outcome) after the intervention and at 12 months, after removal of key access barriers. 
AIM 2:  Compare uptake of genetic testing for HBOC across the three study arms at 6 and 12 months.  
AIM 3:  Compare cognitive (beliefs, attitudes, and knowledge) and affective (distress, stress, fear) intermediate 
endpoints among women in the three study arms and explore potential underlying theoretical mediating and 
moderating mechanisms that will further specify and elucidate significant intervention effects. 
AIM 4: Perform an economic evaluation alongside this randomized controlled trial to estimate the cost 
effectiveness of the two interventions compared to each other and usual care, for uptake of CGRA services from 
the societal and payer perspectives. This aim provides information about the value of the interventions from both 
societal and payer perspectives, given a cost per effect measure and the uncertainty surrounding the estimate. 
 
B. Hypotheses / Research Question(s) 
Primary Hypothesis: Compared to UC, CGRA (genetic counseling) uptake at 6 months (primary outcome) will be 
highest among women participating in the TCN arm followed by women participating in the TP arm. 
 
1.2 Research Significance (Briefly describe the following in 500 words or less): 

 
 
 
Protocol Number: 2018001350 
PI Name: Kinney 
Protocol Title: GRACE Project 
V8 11/6/2024 
 
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HBOC Cancer Risks and Genetic Risk Prediction. Identification of individuals at increased risk of HBOC is crucial 
for cancer survivors and their families to benefit from biomedical advances. In 2015, approximately 254,000 new 
cases of ovarian cancer and female breast cancer were diagnosed in the U.S. Germline mutations in the BRCA1 
and BRCA2 genes account for 5-10% of breast cancers and 15% of ovarian cancers.1-3  This translates to 14,000-
27,000 high-risk cancer survivors who may be impacted 
by HBOC. Women with inherited HBOC gene mutations 
who have had breast cancer are at higher risk of 
ovarian cancer and a second breast cancer (Figure 1), 
and possibly other cancers.4  
Technological advances in DNA sequencing have now 
made it possible to test multiple genes simultaneously 
using multiplex gene panels.2,5-18  
 
CGRA Personalizes Care and is Recommended for 
High-Risk Breast and Ovarian Cancer Survivors. CGRA is an evidence-based strategy that informs medical 
management options that can improve outcomes.14,17,19 CGRA involves genetic counseling +/- genetic testing. 
There is evidence that CGRA by genetic professionals improves accuracy of risk perceptions, enables informed 
decision making, personalizes care, and does not cause adverse psychological outcomes.14,16,20-22  National 
organizations have issued guidelines 
recommending CGRA for breast and ovarian cancer 
survivors who may be at risk for HBOC.17,20,23,24  
CGRA in HBOC survivors impacts public health 
(Figure 2).4,17 If a mutation is identified, testing for 
the known gene mutation can be offered to 
relatives to determine if they have the cancer 
predisposition.20,25 
 
Translation of HBOC Discoveries & Guidelines to Practice Has Been Disappointingly Slow. Genetic counseling, 
guidelines for referral, and testing for HBOC, have been available for >20 years. However, adoption has been 
slow. It is estimated that <50% of high-risk cancer patients receive a CGRA referral from their providers, <35% of 
these women receive genetic counseling and <10% receive testing.4,26-33 Many women who receive referrals do 
not adhere to their provider recommendations.28,34-44  
 
1.3 Research Design and Methods 
This is a retrospective cohort study of women diagnosed with aggressive breast or ovarian cancer in New Jersey, New 
Mexico, and Colorado.  This application covers the work being completed in New Jersey only.  The NJSCR will identify 
women recently diagnosed breast and ovarian cancer who meet the following inclusion/exclusion criteria. (Table 1) 
 
We will not include any of the following special populations: 
• 
Adults unable to consent 
• 
Individuals who are not yet adults (infants, children, teenagers) 
• 
Pregnant women 
• 
Prisoners 
 
 

 
 
 
Protocol Number: 2018001350 
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Protocol Title: GRACE Project 
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Table 1: Inclusion / Exclusion Criteria for NJSCR recruitment 
Cancer Type 
Inclusion 
Exclusion 
Breast Cancer survivors 
Hispanic or non-Hispanic  
Female 
21 years of age or older 
English or Spanish-speaking  
Breast cancer history = 
breast cancer at the age or before age 50 
OR  
triple negative breast cancer at or before 
age 60 OR  
two or more primary breast cancers 
Primary Cancer dx’ed prior to breast 
cancer is OK 
Primary tumor dx’ed after breast cancer 
is OK 
Have had prior genetic counseling or 
testing for hereditary breast and/or 
ovarian cancer 
Unable to give informed consent 
(incoherent, dementia) 
No access to a telephone 
In hospice care 
Incarcerated 
Permanent residence outside of NJ 
Planning on relocating out of NJ within 
the next year 
 
Ovarian Cancer Survivors 
Hispanic or non-Hispanic  
Female 
21 years of age or older 
English or Spanish-speaking  
History of ovarian, fallopian, or 
peritoneal cancer diagnosed at any age 
Primary Cancer dx’ed prior to ovarian 
cancer is OK 
Primary tumor dx’ed after ovarian cancer 
is OK 
Have had prior genetic counseling or 
testing for hereditary breast and/or 
ovarian cancer 
Unable to give informed consent 
(incoherent, dementia) 
No access to a telephone 
In hospice care 
Incarcerated 
Permanent residence outside of NJ 
Planning on relocating out of NJ within 
the next year 
 
A.  Research procedures:   
The NJSCR will conduct patient recruitment following their established Standard Operating Procedures (NJSCR 
Data Repository #Pro20140000992).  
 
Recently diagnosed cases will be identified by staff at the NJSCR and reviewed by a Certified Tumor Registrar (CTR) 
for study eligibility (Table 1).  We will update address information for the case and the physician of record. Each 
person will be assigned an arbitrary study ID and imported into the study tracking database “CRIMSoN.”  NJSCR 
staff will send a letter to the patient’s diagnosing physician of record to notify the physician that his/her patient 
is eligible for participation in the study.  Physicians are asked to notify NJSCR if the patient should not be contacted 
for participation (i.e., deceased). Two weeks after the physician letter is mailed, NJSCR staff will send the eligible 
patient a packet of study materials, including: 
 
1. An introductory letter containing a brief description of the study (English or Spanish), a statement of how the 
patient was determined to be eligible for inclusion into the study, a statement of how the patient was identified 
via the NJSCR, and a request for the patient’s participation; 
2. Two copies (one to sign and return, one to keep) of an “agreement to contact” sheet that contains all aspects of 
informed consent and a location to sign; 
3. An information sheet that contains all aspects of HIPAA; 
4. An NJSCR Study FAQ brochure which aims to answer common questions about the NJSCR and study 
participation; and, 

 
 
 
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5. A postage paid return envelope for the completed Agreement to Contact form. 
 
One week (or five business days) after the initial mailing, staff at the NJSCR will conduct six to eight follow-up 
phone calls at varying times of the day and different days of the week with at least one evening call made between 
the hours of 5-8pm and at least one call made on a weekend. Those reached by phone will be given the option to 
provide a verbal consent to be contacted, which will be recorded in the tracking database. A Spanish-speaking 
NJSCR staff member will contact individuals who indicated Spanish as a preferred language during patient contact.  
Additional recruitment packets will be mailed upon patient request or if returned for an incorrect address. NJSCR 
will track all contact with the patient using the CRIMSoN tracking database.   
 
NJSCR contracted with Salt City Research to design a tracking tool for patient contact studies, particularly mail and 
phone contact, and participant response status.  CRIMSON works with SEER*DMS (NJSCR registry database 
system) and includes modifiable reports and tracking for mode of contact.  Key features of CRIMSON include: (1) 
enhanced report functions and data collection for key recruitment statistics across all studies; (2) enhanced 
interoperability with SEER*DMS to reduce manual entry of data and improve data sharing; (3) improved data 
integrity, quality, consistency, and collection through implementation of validation tools and triggers, elimination 
of data redundancies, and execution of auto-fill and auto-coding of key variables to remove manual entry of data 
whenever possible; and (4) implementation of relational structure of the data system allowing for all studies and 
associated administrative data to be housed within a single data system. 
 
After consent / “Agreement to Participate”, NJSCR staff will transfer data securely for consented individuals to 
the prime site for enrollment and participation in the study.   
 
Briefly, the prime site will randomize the individuals into one of three study arms.  NJSCR will not be involved in 
the intervention.  Women will be randomized to one of three study arms: UC, mailed TP, and TCN delivered by a 
health education specialist. Group assignment will occur at the end of the baseline interview using a 
computerized randomized list. The interventions will take place ideally within 2 weeks but no more than 30 days 
upon completion of the baseline survey. Follow-up surveys will be conducted 1 month (to assess mediation), 6 
months, and 12 months after randomization for the UC arm, and 1 month, 6 months, and 12 months after the 
interventions for TP and TCN arms. During the 6 and 12 month surveys, participants will be asked if they’d like to 
participate in future research. All survey questions will be stored in the REDCap database. The 3 arms will be 
compared with regard to uptake of CGRA at 6 months (primary outcome) and 12 months, and secondary 
outcomes including psychosocial and decision-making factors, CGRA preferences, genetic test uptake at 6 and 12 
months, and cost outcomes at 6 and 12 months. 
 
B. Recruitment in New Jersey will begin in July 2018 once SRB and IRB approvals are received and continue 
through July 2020. The tasks include SRB approval, IRB approval, case identification, “Agreement to Contact”, 
data analysis, and publications.   
Overall Study Timeline for the Principal Investigator (Dr. Kinney) once the person is enrolled: 
• 
The duration of a woman’s participation in the study will be approximately 12-13 months depending on 
study arm. 
• 
The duration estimated for the investigators to complete the study is approximately 5 years and the 
estimated time needed to complete primary and secondary analyses that address all the study’s aims is about 
18 months. 
 
 

 
 
 
Protocol Number: 2018001350 
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Protocol Title: GRACE Project 
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Month 1-7: Start-up, refine data collection and intervention materials, database creation, train health 
education specialists, IRB approvals 
Month 8-32: 
Recruit and conduct baseline surveys 
Months 8-32: 
Intervention implementation 
Months 7-43: 
Intermediate and final outcome assessments, data cleaning 
Months 44-60: 
Data analysis, presentations, reports, manuscript preparation and publications, and 
submit competitive renewal   
 
1.4 Preliminary Data 
Solutions are Needed to Expand Reach and Access, and Reduce HBOC-related Disparities. Psychoeducational 
interventions that inform, motivate, and address barriers and facilitators to clinical services are typically more 
effective in facilitating access to recommended health services.41,45-49 Evidence shows that patients who are 
equipped with skills are more likely to follow through with recommended care and have better outcomes at 
reduced costs.50,51  
 
For our diverse target population, both print and telephone have been found to be acceptable ways to 
communicate CGRA information but tailored counseling and navigation vs. targeted print has not been effectively 
tested in this context.39,52-54 The purpose of this randomized trial is to test the efficacy compared to usual care in 
increasing CGRA for HBOC. Cancer registries are in an ideal position to identify and reach large numbers of high-
risk cancer survivors who may benefit from risk information that can help them make informed decisions about 
their health and/or information pertinent to their biological relatives.55,56  
 
Each year NJSCR participates in a variety of research studies to use data collected by the NJSCR.  Eligible cases are 
actively being contacted for 10 patient contact studies and 2 additional patient contact studies are in the start-up 
phases.  All are approved by the SRB and IRB.  Over the past three years we successfully completed 7 patient 
contact studies that resulted in several scientific publications.  A complete bibliography of successful NJSCR 
research can be found on our website: 
http://www.state.nj.us/health/ces/documents/njscr_bibliography_seer_1980_2017.pdf  
 
 
1.5 Sample Size Justification 
 
The overall study will require a sample size of 642 participants, as shown below in Figure 1, CONSORT flow 
diagram.  The 642 (214 per arm) high-risk breast and ovarian cancer survivors will be randomized to one of the 3 
study arms.  Participants will be recruited from both the NM, NJ, and CO cancer registries. In New Jersey, we will 
contact 7,000 breast and ovarian cancer survivors to obtain 700 consents, expecting that 50% of identified 
individuals sampled and screened for eligibility will fall under our exclusion criteria or will be ineligible for other 
reasons, 25-28% will consent, and we will retain 80% over the course of the study.  Table 2 shows the number 
of cases available for contact from the NJSCR. 
  
Based on our experience recruiting through population-based tumor registries there are no anticipated barriers 
or challenges that will prevent us from reaching our accrual goal and we believe that enrollment will be feasible. 
Standard methods are used to estimate contact and response rates113 and these rates are consistent with other 
studies that used similar population-based sampling and recruitment strategies for health promotion intervention 
studies in our region (response rates are typically higher for female survivors).54,57,109,114-116 Based on our 
calculations and considerable experience recruiting individuals from state cancer registries to epidemiologic and 

 
 
 
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behavioral intervention studies, we are confident that we have a sufficient pool of women who are at increased 
HBOC risk to recruit into the study. Using data from cancer registries in NJ, NM, and CO, we can estimate the 
number of potentially eligible living female breast and ovarian cancer survivors who meet the criteria for a referral 
for CGRA by a credentialed genetic professional.  
 
 Table 2: Number of Eligible Women, by cancer type, NJ, annual estimates 
 
 
 
 
 
 
 
 
 
New Jersey State Cancer Registry October 25, 2016 analytic file. Processed in December 2017.  
*Annual averages are based on counts from the five most recent diagnosis years (2011-2015) 
 
Cancer Type 
NJ Annual* No. of 
Eligible Cases 
% Hispanic 
Ovary 
269 
10 
Fallopian Tube 
21 
<1 
Peritoneal 
14 
<1 
Breast Early Onset 
1849 
18 
Breast Triple Negative 
425 
16 
Breast 2+ primaries 
1059 
10 

 
 
 
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Figure 1: Overall Sample Size and Study Design 
 
 

 
 
 
Protocol Number: 2018001350 
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1.6 Study Variables 
A. Independent Variables, Interventions, or Predictor Variables  
Intervention Arms. Following completion of the baseline survey, participants will be randomly assigned to 1 of 3 
study arms: 1) a Usual Care (UC) control arm; 2) a mailed Targeted Print arm (TP); and 3) Tailored Counseling & 
Navigation (TCN) arm. We hypothesize that the TCN intervention will increase CGRA uptake significantly compared 
to UC and the TP intervention. 
Arm 1- Usual Care: A usual care arm is included to assess GGRA uptake in the absence of intervention as well as 
priming from the surveys for the primary outcome analysis.  
Arm 2- Mailed Targeted Print: Participants randomized to this arm will be mailed an educational brochure within 
two weeks of completing the baseline survey. The brochure will be available in English and Spanish. It addresses 
important evidence-based theoretical targets: CGRA guideline (knowledge), threat appraisal (to validate or raise 
risk perceptions, HBOC seriousness), response efficacy (benefits and expectations about CGRA), self-efficacy 
messages (CGRA resources, insurance reimbursement, assistance for those with financial challenges), and possible 
actions to take (make an appointment and discuss with provider). As described in Section D.1, both the targeted 
print and tailored intervention materials (described below) were developed using formative community engaged 
research methods.119 
Arm 3 - Telephone Counseling & Navigation: Within one month of the baseline survey, a bilingual health 
education specialists will conduct a 30-45 minute (depending on participant needs) telephone health education 
and counseling session with women randomized to this arm. The intervention will be offered in English or Spanish, 
depending on the participant’s preference. Because theoretically-based tailored messages are generally more 
effective than generic messages in producing behavioral change,91,120 we will individualize the psycho-education 
and navigation session according to each participant’s perceptions of threat and efficacy as derived from the 
EPPM,41,100 and according to personal factors such as HBOC and CGRA awareness, family history, cultural factors 
(e.g., ethnicity, language preference, familism, fatalism, family history), psychological and logistical concerns, 
knowledge, and barriers to CGRA that arise during the phone call. Prior to the telephone session, participants will 
receive the same brochure that the TP arm receives. After the phone call, participants will receive a tailored follow-
up letter. It will include images tailored to the individual’s age, self-identified ethnicity, and family composition. 
Health education specialists will enter this into the study database using user-friendly study-specific computer 
screens similar to our previous work.41,100 The Michigan Tailoring System (MTS), a publicly available software 
program, will be used to individually tailor messages and images using demographic, clinical and patient-reported 
data (http://chcr.umich.edu/mts/) for the letter. This information will be derived from the cancer registry data 
(age, type of cancer diagnoses) and during the survey or phone call (ethnicity, family history, primary care provider 
(which may be an oncology specialist), threat and efficacy appraisals, concerns (e.g., family member’s risk and/or 
risk of second cancer, family orientation), top two CGRA facilitators/benefits and top two barriers, and action plan.  
Both the health education specialists coaching and tailored letter incorporate evidence-based communication and 
behavior change approaches designed to raise the participant’s perceptions about the threat (to herself and at-
risk family members), arouse emotions and manage fear, enhance positive beliefs about CGRA (response efficacy), 
and increase self-efficacy by addressing barriers, facilitators, and motivation to get CGRA.39,42,51,121-128 The health 
education specialist will use a MI style to help participants explore their reasons for getting CGRA, resolve 
ambivalence/decisional conflict, and develop their own action plans. The outline of the call is summarized in Table 
3.  

 
 
 
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Table 3. Overview of TCN Arm  
Step 1: Introduction and Rapport Building.   
Step 2: Address HBOC Threat Perceptions. To enhance HBOC risk perception, the health education specialist 
elicits the women’s awareness and thoughts about the CGRA referral guidelines and how these guidelines 
apply to them. The health education specialist provides information about the participant’s personal risk for a 
HBOC-related second cancer and acknowledges that male and female blood relatives may be at increased 
cancer risk. Although we anticipate that the vast majority of participants will perceive HBOC as serious, their 
responses will be used to enhance cognitive processing of information.  
Step 3: Address Barriers and Efficacy. The health education specialist elicits the participant’s response efficacy 
beliefs, including risk management options for HBOC. If desired by the participant, the health education 
specialist describes the CGRA/genetic counseling process; its effectiveness in helping women like them and 
their blood relatives; and addresses questions, concerns or misconceptions about CGRA (e.g., getting CGRA 
does not mean one has to have a genetic test). The health education specialist uses the “Importance” Ruler (1 
- 10 scale) to elicit participant talk around desire and reasons for CGRA. The health education specialist uses 
the “Readiness” Ruler (1 - 10 scale) to elicit participant talk around ability, confidence, and commitment to 
obtain CGRA within the next six months. Throughout the interaction, the health education specialist will utilize 
a series of open-ended questions to elicit and reinforce the participant’s reasons for undergoing CGRA. The 
health education specialist explores factors that the participant believes would increase priority and/or efficacy 
to get a CGRA. The health education specialist also elicits and addresses the participant’s two most important 
barriers to getting CGRA and attempts to resolve during the phone call.  
Step 4: Construct an Action Plan. Using readiness ruler and action planning visual aids, the health education 
specialist prompts the participant to create a personalized action plan. The health education specialist applies 
implementation intention principles by encouraging the participant to formulate a plan to obtain a CGRA, to 
determine what her first step will be, as well as when and how she will execute the plan. 
Step 5: Provide Navigation as Needed. To further bolster self-efficacy and behavior change, the  health 
education specialist offers further assistance (navigation) to help the patient overcome barriers and asks 
permission to follow-up with them to provide further help as needed. The dose and follow-up navigation 
activities will be tracked and analyzed as process variables.  
Step 6: Summary, Closing and Follow-up. The health education specialist provides a summary of the 
participant’s self-identified primary reasons for getting CGRA, how to overcome the top two barriers as well as 
the action plan. The health education specialist asks permission to send a letter to the patient’s primary 
provider letting them know that the participant meets the referral criteria for CGRA according to national 
guidelines and a copy of the participant’s tailored letter. For participants who identify barriers, the health 
education specialist delineates the next steps and schedules a time to follow-up with the patient by phone. A 
computer generated tailored letter will be mailed immediately after the phone session that includes the 
women’s personalized action plan.  

 
 
 
Protocol Number: 2018001350 
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B. Dependent Variables or Outcome Measures 
 
a) Primary Objective: To compare the effectiveness of a usual care (UC) vs. targeted generic print (TP) vs. tailored 
telephone counseling and navigation intervention (TCN) on cancer genetic risk assessment (CGRA) uptake at 
6 months for hereditary breast and ovarian cancer (HBOC). 
 
Primary Endpoint: Medical record verified CGRA uptake at 6 months and at 12 months after removal of 
key access barriers 
 
b) Secondary Objective 1: Compare uptake of genetic testing for HBOC across the three study arms at 6 and 12 
months. 
 
Secondary Endpoint 1: Medical record verified genetic testing uptake at 6 and 12 months. 
 
c) Secondary Objective 2: Compare cognitive (beliefs, attitudes, and knowledge) and affective (distress, stress, 
fear) intermediate endpoints among women in the three study arms and explore potential underlying 
theoretical mediating and moderating mechanisms that will further specify and elucidate significant 
intervention effects 
 
Secondary Endpoint 2: Measures of cognitive and affective psychological constructs at 1 and 6 months. 
 
d) Secondary Objective 3: Perform an economic evaluation alongside this randomized controlled trial to estimate 
the cost effectiveness of the two interventions compared to each other and usual care, for uptake of CGRA 
services from the societal and payer perspectives. This aim provides information about the value of the 
interventions from both societal and payer perspectives, given a cost per effect measure and the uncertainty 
surrounding the estimate. 
 
Secondary Endpoint 3: Cost analysis at 6 and 12 months 
 
1.7 Specimen Collection as a Primary Source 
Not Applicable 
 
1.8 Interviews, Focus Groups, Surveys, and/or Observations  
A. Administration 
NJSCR SITE: 
Recently diagnosed cases will be identified by staff at the NJSCR and reviewed by a Certified Tumor Registrar for 
study eligibility.  We will update address information for the case and the physician of record. Each person will be 
assigned an arbitrary study ID and imported into the study tracking database “CRIMSoN.”  NJSCR staff will send a 
letter to the patient’s diagnosing physician of record to notify the physician that his/her patient is eligible for 
participation in the study. Two weeks after the physician letter is mailed, NJSCR staff will send the eligible patient 
a packet of study materials.  One week (or five business days) after the initial mailing, staff at the NJSCR will 
conduct six to eight follow-up phone calls at varying times of the day and different days of the week. Those 
reached by phone will be given the option to provide a verbal consent to be contacted, which will be recorded in 
the tracking database. A Spanish-speaking NJSCR staff member will contact individuals who indicated Spanish as 
a preferred language during patient contact.  NJSCR will track all contact with the patient using the CRIMSoN 
tracking database.  After consent / “Agreement to Participate”, NJSCR staff will transfer data securely for 
consented individuals to the prime site for enrollment and participation in the study. 
 
PRINCIPAL INVESTIGATOR SITE: 

 
 
 
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All interventions and surveys will be conducted by the Principal Investigator at the prime site.  Women will be 
randomized to one of three study arms: UC, mailed TP, and TCN delivered by a health education specialist. Group 
assignment will occur at the end of the baseline interview using a computerized randomized list.  
 
Timing and Frequency 
The overall order of events for the study are in Table 4.  NJSCR is responsible for recruiting cases. 
Table 4: Study Timeline 
Who 
Task 
Timeline 
  
  
NJSCR
Recruitment and 
Consenting 
Start - Up Phase August 2018 
  
PI 
Enrollment, 
Baseline Survey & 
Randomization 
Baseline 
  
  
PI 
Intervention  
14-30 days post-
baseline 
  
  
PI 
Follow up surveys 
Arm 1: Usual Care (UC) 
Arm 2: Targeted 
Mailed Print (TP) 
Arm 3: Telephone 
Counseling & 
Navigation (TCN) 
PI 
               1 month 
30 d > randomization 
30 d > intervention 
30 d > intervention 
PI 
               6 months 
180 d > randomization 
180 d > intervention 
180 d > intervention 
PI 
              12 months 
360 d > randomization 
360 d > intervention 
360 d > intervention 
 
 Location 
Case recruitment using the New Jersey State Cancer Registry will occur at the NJSCR Trenton Office (135 
East State Street, Trenton, NJ) and the New Brunswick office (120 Albany Street, New Brunswick, NJ)  
 
 Procedures For Audio And Visual Recording  
Not applicable 
 
 Person Identifiers 
Staff at the New Jersey State Cancer Registry will identify and contact eligible breast and ovarian cancer 
survivors following their established Standard Operating Procedures (NJSCR Data Repository 
#Pro20140000992). If a woman would like to participate in the research study, she will be required to sign 
an informed consent form / “Agreement to Contact” which will describe all aspects of informed consent, 
contain information about the HIPAA Privacy Rule, and fully describe study participation.  If the woman 
chooses not to participate, she does not have to return the consent form and if she chooses to participate 
she can withdraw at any time.   
 
On the consent form / “Agreement to Contact” a woman can give the NJSCR staff permission to release 
private identifiable information (PII) to the Principal Investigator.  The variables that will be needed are: 
name, all elements of the address at diagnosis and current address, telephone number, demographic 
variables (i.e., gender, race, age, date of birth, etc.) and cancer-related variables (i.e., date of diagnosis, 
cancer type, etc.).  NJSCR will need to provide these variables to the Principal Investigator so that the 
woman can be contacted for enrollment, baseline survey, randomization, and interventions.  

 
 
 
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To protect personal identifiers, each woman will be assigned an arbitrary identification number and this 
will be used for communication between research staff.  Any PII will be transferred in a secure, encrypted 
manner.  All electronic data will be backed up regularly on a secure server.  As aforementioned, the 
biostatisticians who analyze the data will be blinded to participant’s study arm.  Data for this study, 
including PIII, will be stored by NJSCR for 6 years after study completion as required by the Rutgers IRB. 
 
B. Study Instruments 
All recruitment materials, surveys, and intervention materials will be available to participants in English or Spanish, 
depending on their preference. The TCN session will be conducted in English or Spanish, depending on the participant’s 
preference. Spanish materials will be submitted to the IRB after the English materials have been approved. To further 
facilitate communication, Spanish speaking participants and study staff may use over the phone translation services.  
 
There will be 4 surveys over the course of the study period (baseline, 1 m, 6m, 12 m) and will include different components 
as described below.  These are developed at the prime site. 
CGRA Decision and Genetic Test Uptake: Participants who have CGRA within 6 months of the intervention (or baseline 
survey for UC arm) will be considered “completers” of CGRA for the primary outcome. The primary outcome is medical 
record verified CGRA delivered by the 6-month follow-up. Those reporting that they had CGRA will be asked to sign a 
medical release form so that we may verify their self-reported CGRA. This approach is extremely feasible and has been 
successful in ours’41,134 and others’135,136 prior work. We will track the type of provider (e.g., physician, genetic counselor, 
etc.) who provided CGRA and document their genetics training via the documentation form. Using the same strategy, we 
will assess CGRA utilization at 12 months. Through the medical record release signed by patients, self-reported genetic 
testing (including type of test and test result) will also be medical record verified at 6 and 12 months.  
Sociocultural Factors and Cues to Action: 1) Sociodemographics: age, gender, education, household income, financial 
status, marital status, rural-urban community area code,137 living biological children, and health insurance status, country 
of origin, years lived in the U.S; 2) Medical history: personal/family history of cancer, cancer stage, heath status, co-
morbidity index; 3) Acculturation: Short Acculturation Scale;138 4) Family and friends social support and encouragement 
to obtain CGRA;41,139,140 5) Family orientation: The Familism Scale;141 6) Brief Fatalism Scale;142,143 7) Health System 
Distrust;144 8) Receipt of a physician/provider recommendation for CGRA; and 9) Primary health care provider received 
tailored letter in the TPN arm. 
Cognitions/Beliefs: 1) Perceived risk: Distinct items with established predictive validity will assess absolute and 
comparative risk perceptions about risk of carrying a HBOC gene mutation and family members’ risk of HBOC;39,41,54,145,146 
2) Self-efficacy: items assess women’s confidence in their ability to locate CGRA services and obtain such services;39,100 3) 
Response efficacy: beliefs about benefits of CGRA in helping prevent HBOC, managing personal cancer risks, providing 
important information for family, helping make decisions about genetic testing, and helping cope with risks; 42,126 4) 
Subjective Numeracy: validated items from the Subjective Numeracy Scale to assess self-reported numeracy skills;147,148 
5) Genetic Self Efficacy: items assess women’s confidence in their ability to understand genetic information and how it 
applies to their own health;149-151 6) Genetic Information Non-Discrimination Act (GINA) Law Confidence: belief that the 
GINA law would adequately protect against genetic based discrimination;152 7) Decisional conflict associated with the 
CGRA and gene test decisions will be measured with the SURE Scale;153,154 8) Decisional satisfaction about CGRA and gene 
test decisions will be measured with a 4-item scale155-157 and 3 additional items that assess how they feel about their 

 
 
 
Protocol Number: 2018001350 
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15 
 
 
 
CGRA/testing decision in relation to their family; 9) Decision Regret Scale will assess regret related to their decision to 
have or not have CGRA;54,158 and 10) Several items will assess CGRA and testing intentions.126 
Knowledge: Items from the National Center for Human Genome Research Knowledge Scale and additional items specific 
to breast and ovarian cancer survivors and misconceptions concerning CGRA and genetic testing will be used.159,160 We 
will also ask participants if they heard about or were referred for CGRA and HBOC genetic testing (e.g., BRCA1/2) prior to 
being contacted for this study. 
Facilitators and Barriers Regarding CGRA: Items will be drawn from prior research, including our own work.39,42,122,126 
Barriers at the individual, interpersonal, structural, and system-level will be assessed.39,42,122 Facilitators include but are 
not limited to: help from family, desire to reduce risk, and referrals from medical professionals. We will also document 
the most important barriers and facilitators.  
Health Literacy: Psychometrically validated items161,162 from the Short Test of Functional Health Literacy in Adults. 
Emotions: 1) Fear of HBOC risk (self, family): Affect in Risk Scale;145,163,164 2) Cancer Worry Scale; 165,166 3) Psychological 
distress: anxiety and depression subscales of the Brief Symptom Inventory,167-169 Short Perceived Stress Scale;170,171 4) 
Defensive Avoidance172,173 
CGRA Mode Preferences: At the 6-month follow-up, we will elicit their preferred mode of CGRA delivery (telephone, 
internet (Skype), or in-person) and reason for this preference. 
Reactance to Intervention Materials:  At the 1-month survey, participants will be asked if they received and read the print 
intervention materials (e.g., brochure, tailored letter, reminder action plan) and had telephone coaching.53 For those who 
respond “yes,” 53,174-176 open-ended questions will also be included regarding what participants liked and did not like about 
the materials. 
Future Research: At the 6 and 12 month surveys, participants will be asked if they are interested in participating in future 
research.   
Cost Data Collection:  For the economic assessment, we will collect data on: 1) cost of print materials and mailings; 2) 
health education specialist time to deliver the intervention and follow-up navigation; 3) participant out-of-pocket and 
time costs; 4) costs associated with the CGRA and genetic test (BRCA1/2 or gene panel test); and 5) overhead related to 
the intervention (space, etc.). Time will be valued at US wages rates using data from the US Bureau of Labor Statistics.177 
Some costs will obviously differ by study arm (e.g., telephone/internet charges and time), but other differences may be 
less obvious. Since we are interested in future replication costs, we will focus on intervention delivery costs, including 
events and health care use. Briefly, health education specialists will record time and resources used delivering the 
interventions on participant encounter forms; these forms will be compiled to calculate averages. Participants will asked 
questions regarding how much time they spent, how much childcare they paid for, and how many miles they traveled for 
each preventive measure, cancer genetic risk assessment, or genetic test they report getting. We have successfully used 
these methods previously.54,178,179 
 
 
 
 

 
 
 
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Table 5. Concordance Table of Measures 
Measure 
Base-
line 
1mo 
6mo 
12mo 
Description  
General Health and Clinical 
Information 
x 
 
 
 
Heath status, co-morbidity index, 
information on cancer diagnosis(es) 
Prophylactic Measures 
x 
 
x 
x 
Assess uptake of and intention to get 
mastectomy, mammography, breast MRI, 
oophorectomy, CA 125, and pelvic 
ultrasound. Participants will also report on 
how much time they spent getting each 
procedure, how much childcare they paid 
for, and how many miles they had to drive. 
Psychological Distress167,168: 
BSI anxiety ( = 0.79-0.81);  
BSI depression ( = 0.84-.085); 
Short PSS170,171 ( = 0.84-0.86) 
x 
x 
x 
x 
Psychological distress will be assessed using 
the following: anxiety and depression 
subscales of the Brief Symptom 
Inventory;167,168 Short Perceived Stress 
Scale.170,171  
Cancer Worry: The McCaul Brief 
Worry Scale165,166 ( = 0.78) 
x 
x 
x 
x 
Three items will assess cancer worry using 
the McCaul Brief Worry Scale165,166  
Fear of HBOC: Affect in Risk 
Scale145,164 ( = 0.94) 
x 
x 
x 
 
Fear of HBOC will be assessed using 6 items 
in the Affect in Risk Scale.145,164  
Defensive Avoidance 
x 
x 
x 
 
Four items assess avoidance in thinking 
about personal and familial inherited cancer 
risk.172,173 
Perceived HBOC risk for self and 
family146,180,181. Perceived threat 
and efficacy regarding HBOC:  Risk 
Behavior Diagnosis Scale 
(RBDS)182,183 ( = 0.76-0.92) 
x 
x 
x 
 
Four items assess perceived HBOC risk for 
self and family146,180,181. Threat and efficacy 
related to HBOC is assessed using the RBDS 
which assesses cancer-focused EPPM 
constructs (perceived risk, response efficacy, 
self-efficacy, cancer severity).182,183  
HBOC Knowledge: National Center 
for Human Genome Research 
Knowledge Scale160  
( = 0.74) 
x 
x 
 
 
HBOC knowledge will be assessed using 
items from the National Center for Human 
Genome Research Knowledge Scale.160 
Additional items specific to breast and 
ovarian cancer survivors159 have been 
added, as well as items to assess 
misconceptions concerning hereditary 
cancer, CGRA, and genetic testing 

 
 
 
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Family Cancer History 
x 
 
 
 
Family history of cancer: relative, cancer 
type, age at diagnosis, etc. 
Prior Access to CGRA and Genetic 
Testing 
x 
 
 
 
Will assess whether participants had heard 
about CGRA and/or were referred for CGRA 
and HBOC genetic testing (e.g., BRCA1/2) 
prior to being contacted for this study 
Physician/Health Care Provider 
Recommendation and 
Communication 
x 
x 
x 
x 
Will assess whether healthcare providers 
have discussed participant’s risk of HBOC 
and CGRA, and how participants feel 
discussing CGRA and genetic testing with 
health care provider. 
Cancer Genetic Risk Assessment 
(Genetic Counseling) 
 
x 
x 
x 
Participants will be asked whether they have 
had CGRA, the provider who conducted the 
CGRA, and the provider’s genetics training.  
CGRA will be medical record verified. 
Cancer Genetic Risk Assessment 
Intention 
x 
x 
x 
x 
One item will measure future intention to 
get cancer genetic risk assessment. In follow 
up surveys, this will only be asked if 
participant does not report uptake of CGRA 
HBOC Genetic Testing Uptake 
 
x 
x 
x 
Participants will be asked whether they have 
had HBOC genetic testing, what type of 
genetic test they had, and the facility where 
the testing was done. Genetic testing will be 
medical record verified. 
HBOC Genetic Testing Intention 
x 
x 
x 
x 
One item will measure future intention to 
get genetic testing for HBOC. In follow up 
surveys, this will only be asked if participant 
does not report uptake of genetic testing. 
Decisional conflict for CGRA: SURE 
Scale153,154 ( = 0.86) 
 
x 
x 
x 
Decisional conflict associated with the CGRA 
decision will be measured separately with 4 
items using the SURE Scale153,154 
Decisional conflict for HBOC genetic 
testing: Low Literacy Decisional 
Conflict Scale (DCS)SURE Scale153,154 
( = 0.86) 
 
 
x 
x 
Decisional conflict associated with the HBOC 
gene test decision will be measured 
separately with 4 items using the SURE 
SCALE153,154 
Decisional satisfaction with CGRA: 
Satisfaction with Decision 
Instrument155,156  
( = 0.90). 
 
 
x 
x 
Decisional satisfaction will be assessed using 
the Satisfaction with Decision 
Instrument.155,156  Four questions assess 
their personal satisfaction with their 
decision and three additional items assess 

 
 
 
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how they feel about their CGRA decision in 
relation to their family. 
Decision Regret Scale158 
( = 0.81-0.92) 
 
 
x 
x 
Five items will ask about regret regarding 
the decision to have or not have CGRA.158 
CGRA and HBOC Genetic Testing 
Facilitators42,126 
 
x 
x 
x 
x 
Facilitators include but are not limited to: 
help from family, desire to reduce risk of 
second cancers, and help/referrals from 
medical professionals. 
CGRA and HBOC Genetic Testing 
Barriers39,42,122 
x 
x 
x 
x 
Barriers include but are not limited to: low 
perceived importance, competing demands, 
family members’ lack of support, travel time, 
lack of insurance reimbursement. 
Fatalism (fatalismo) and destiny 
(destino)142,143 
x 
x 
 
 
Fatalism (fatalismo) and destiny (destino) 
beliefs will be evaluated with three 
items.142,143 
Competing Life Concerns126 
x 
x 
 
 
Competing life concerns will be evaluated 
with three items.126 
GINA Confidence 
x 
x 
 
 
Assess belief that the Genetic Information 
Non-Discrimination Act (GINA) law would 
adequately protect against genetic based 
discrimination. 
Health System Distrust Scale144 
x 
 
 
 
Nine items measure one’s distrust of the 
Health Care System. This measure has been 
psychometrically validated.144 
Health Literacy Screen161,162  
x 
 
 
 
Psychometrically validated items used to 
asses health literacy in adults.161,162 
Genetic Self Efficacy151 
x 
x 
x 
 
Five items used to assess confidence in 
ability to understand genetic information 
and how it applies to personal health and 
disease risk.151 
Subjective Numeracy147,148 (α=0.78) 
x 
 
 
 
Three items used to assess self-reported 
numeracy skills and preferences. 
Acculturation: 
Short Acculturation Scale138  
( = 0.90) 
x 
 
 
 
Acculturation is assessed by country of 
origin, time in the U.S., and language 
preference (five items from the Short 
Acculturation Scale).138 

 
 
 
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19 
 
 
 
Social support and encouragement 
to get CGRA41,139,140  
 
x 
x 
 
Six items assess the extent to which family 
and friends impact one’s intention or ability 
to get a CGRA for HBOC. The measure was 
expanded from the 2-item measure of family 
support139,140 to assess more aspects of 
family influence; tangible support, 
emotional support, and normative influence. 
Family Orientation: The Familism 
Scale141 ( = 0.87) 
x 
 
 
 
Family orientation (Familism) assess the 
relative imporance of self and family where 
the needs of family are more important and 
take precedence over the needs of any of 
the family members. The Familism Scale has 
been used in several Latino samples.141,184,185
 
 
Sociodemographic 
x 
 
 
 
Age, gender, ethnicity, education, household 
income, financial status, marital status, 
rural-urban community area code,137 living 
biological children, employment status. 
Health Insurance Information 
x 
 
x 
x 
Health insurance status and changes in 
insurance 
CGRA Mode Preferences 
 
 
x 
 
At the 6-month follow-up, for those who 
have not had genetic counseling but desire 
it, we will elicit their preferred mode of 
CGRA delivery: telephone, internet (Skype), 
and in-person along with the reason 
underlying their preference. 
Reactance to Intervention 
Evaluation 
Items adapted from previous 
work41,53,173-175  
 
x 
 
 
At the one month survey, participants will 
be asked if they received the print 
intervention materials and telephone health 
education specialist coaching from the 
GRACE Project.53 For those who responded 
“yes” to specific materials, a set of 174,175 
participants will be asked open-ended 
questions regarding the materials. 
Participants will also report how much time 
they spent reviewing materials and speaking 
to a cancer education specialist. 
Cancer Education Specialist Follow 
Up 
 
 
x 
x 
Participants will report how long they spoke 
on the phone during follow up calls with the 
cancer education specialist. 

 
 
 
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20 
 
 
 
Future online adaptations 
 
x 
 
 
Following intervention, internet usage and 
willingness to search for genetic service 
information will be assessed. 
Cost Data 
 
 
x 
x 
Several items will be used to conduct a cost 
analysis  
 
2.0 Project Management 
 
2.1 Research Staff and Qualifications 
New Jersey State Cancer Registry Staff 
Antoinette Stroup, PhD, NJSCR Site-Principal Investigator 
Dr. Stroup is the Director of the New Jersey State Cancer Registry. As such she will be responsible for oversight of this 
project at the NJSCR, including sample selection, participant recruitment, data collection and quality control. She will lend 
her expertise in cancer surveillance, population-based survey research and participate in manuscript writing and 
presentation of study findings at scientific meetings.  As the Director of Cancer Epidemiology Services (CES) and the New 
Jersey State Cancer Registry (NJSCR) and Principal Investigator of the New Jersey SEER contract, she oversees all 
administrative and operational aspects of the NJSCR, and manage and oversee all research-related activities (e.g., protocol 
development, institutional review board compliance, patient contact) through the CES Cancer Research Program. She has 
over 15 years of experience in population-based cancer surveillance methods and research including prior work at two of 
the highest performing state cancer registries in the SEER Program. 
 
Lisa E. Paddock, MPH, PhD – Program Manager 
Dr. Paddock is the Deputy Director of the Cancer Surveillance Research Program, which operates under the direction of 
the NJSCR Director (Dr. Stroup).  Dr. Paddock has nearly 20 years of experience in epidemiologic research and patient 
contact studies, 15 years of which were spent doing research with the NJSCR data. Dr. Paddock’s experience is in outcomes 
research, with specific training in cancer epidemiology, survey research, and health-related quality of life and she is 
currently a co-investigator in six patient contact studies where NJSCR-CSRP is recruiting and surveying cases.  Dr. Paddock 
has experience in contacting breast and ovarian cancer survivors for case-control studies that are similar to the work 
proposed in this application. 
 
Jie Li, MPH – Team Lead 
Ms. Li is a Masters trained epidemiologist and data analyst who is a Research Scientist in the New Jersey State Cancer 
Registry – Cancer Surveillance Research Program.  In this role, Ms. Li conducts registry-based analytics using data from the 
New Jersey State Cancer Registry database (SEER*DMS), and other state and national cancer registry data sources 
available through SEER*Stat. She is a member of the Patient Contact Studies Team and the Data Linkage Team and assists 
in linking cohorts with NJSCR data.  Additionally, she assists researchers who would like to use NJSCR data in preparing 
linkage cohort study protocols and IRB applications, analyzes NJSCR data and develops data reports.  Ms. Li has several 
years of experience successfully leading patient contact studies for the NJSCR, including the CEASAR Study and SEER 
Willingness to Participate.       
 
Natalia L. Herman, MPH - Coordinator 
Ms. Herman holds a Master’s Degree in Public Health with supplemental training in project management and eight years 
of experience administering, coordinating, and managing survey research projects. Ms. Herman’s expertise is in 
conducting patient contact studies and surveying patients and studies of various aspects of NJSCR data such as rapid case 

 
 
 
Protocol Number: 2018001350 
PI Name: Kinney 
Protocol Title: GRACE Project 
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21 
 
 
 
ascertainment and medical record abstraction.  Ms. Herman is the Project Manager for the CRIMSON database, providing 
operational and functional guidance to staff utilizing the database as well as acting as point of contact for the outside 
consultant, and internal database administrator in the creation of a web-based version. She will coordinate the day-to-
day operations of the patient contact staff and provide training to those who are  
 
Cynthia G. Nunez, BS – Spanish Interviewer 
Ms. Nunez is a Research Teaching Specialist III with the NJSCR-Cancer Surveillance Research Program and is the staff 
member who can translate and speak Spanish to eligible patients.  Ms. Nunez has more than 10 years of experience 
working with patients and sensitive populations prior to her work at NJSCR-CSRP. Ms. Nunez’s primary responsibility is 
maintaining Scientific Review Board and Institutional Review Board approvals for research studies, coordinating patient 
contact mailings and patient phone calls, and provides training and mentoring for new staff members. 
 
Overall Principal Investigator 
Anita Y. Kinney, PhD, RN, Principal Investigator - Dr. Kinney holds the Carolyn R. Surface Endowed Chair in Population 
Sciences and is Professor of Epidemiology in the Department of Internal Medicine at the University of New Mexico (UNM) 
School of Medicine. She is also the Associate Director for Cancer Control and Population Sciences at the UNM Cancer 
Center. Dr. Kinney has primary responsibility for directing all scientific and administrative activities associated with this 
project. She works closely with the Senior Program Manager and Project Coordinator, who ensures staff are adequately 
trained and are meeting study progress benchmarks and day-to-day oversight of study staff data collection activities, 
recruitment, and retention of participants. Dr. Kinney leads the intervention design and implementation strategy, and 
works closely with the Senior Program Manager and Project Coordinator to ensure adherence to the study’s timeline. She 
will oversee data analysis and dissemination of the study findings and submission of the competitive grant renewal 
application. 
 
2.2 Resources Available 
 
A. Facilities 
Cancer cases diagnosed in New Jersey will be obtained from the New Jersey State Cancer Registry (NJSCR), located 
within the Cancer Epidemiology Services (CES) program at the New Jersey Department of Health (NJDOH). The 
NJSCR is managed and supported by Rutgers Cancer Institute of New Jersey (CINJ) through a Memorandum of 
Agreement between the NJ Department of Health and Rutgers, The State University of NJ. NJSCR receives funding 
from the National Cancer Institute, the Centers for Disease Control, and other state and federal programs.  The 
NJSCR is a population-based cancer registry dedicated to tracking the occurrence of cancer in the state of New 
Jersey since 1978. The NJSCR contains information on all cancer cases including the type of cancer, race, gender, 
age residence at diagnosis, first course of treatment, and survival and, has received recognition for its high quality 
and timely data. The CRP collaborates on and conducts cancer research studies, publishes findings in scientific 
journals, analyzes data from the NJSCR and produces statewide cancer incidence, mortality and other specialty 
reports that inform cancer prevention and control efforts. 
 
The NJSCR employs a full complement of experienced cancer registration, research, and information systems 
personnel to successfully meet its goals for statewide cancer surveillance and research support. Research and data 
use are primarily managed and conducted by research scientists in the Cancer Surveillance Research Program 
(CSRP), under the leadership of the Director (Dr. Stroup) and Deputy Director (Dr. Paddock). The senior Research 
Scientists manage several research studies and participate in cancer control and prevention initiatives using NJSCR 
data. Investigators are required to work collaboratively with CSRP staff when developing a research protocol using 
NJSCR data. Staff members at NJSCR and CSRP are well trained in cancer registration and surveillance research 

 
 
 
Protocol Number: 2018001350 
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22 
 
 
 
including patient contact studies. CES will support this project by providing key technical and research support for 
patient contact and provide critical content expertise to the research team in regards to cancer surveillance data 
and interpretation of results. 
 
The physical location of NJSCR: 135 East State Street, 1st Floor, Trenton, NJ 08625 and 120 Albany Street, Tower 
2, 8th Floor, New Brunswick, NJ 08903. Location of Data (Hosted by NCI contractors, remotely):  Information 
Management System (IMS), Inc., TierPoint Baltimore Data Center 1401 Russell Street, Baltimore, MD 21230. 
 
Primary registry operations are located at the NJDOH, 135 East State Street, Trenton, NJ 08625 where key card 
access to the building and registry space on the 1st floor is required.  All visitors must be registered with building 
security. Per state policies, all cancer registry staff must display their state-issued ID at all times while on the 
premises. (Note: all employees hired through CINJ are issued state IDs upon employment.)  Paper-based 
documents with identifiable data for cancer cases and employees are stored daily at the close of business in locked 
filing cabinets and drawers. Employees are also required to log- off or lock desktop computers when they step 
away from their workspace. The registry has staff working at the Rutgers-New Brunswick Campus in CINJ, 120 
Albany Street, Tower 2, 8th Floor, where key card access is also required and who follow the same procedures for 
securing paper-based documents with identifiable information and securing workstations as described above. 
 
B. Medical Or Psychological Resources 
Not Applicable  
 
C. Research Staff Training 
NJSCR staff involved in this study have been with CSRP for up to 5 years, and the majority possess a college or 
graduate degree. They attend regular trainings for phone interviewing and speaking with cancer survivors 
regarding NJSCR and study participation.  All staff are trained on Confidentiality Procedures and are required to 
sign a confidentiality agreement annually.  Study specific training will include: 
1. 
The purpose and scope of the study; 
2. 
Review of roles and responsibilities of each staff and NJSCR; 
3. 
Review of the questionnaire; 
4. 
Review of frequently asking questions. 
 
2.3 Research Sites 
The NJSCR will facilitate enrollment of New Jersey patients who consent to participate in the study and provide contact 
information for these consented women to the Principal Investigator so that they can be contacted for study activities.  
Recruitment of the NJ cases will be performed at the New Jersey State Cancer Registry offices:  
 
135 East State Street, 1st Floor, Trenton, NJ 08625  
 
120 Albany Street, Tower 2, 8th Floor, New Brunswick, NJ 08903  
 
Recruitment will also occur at the state cancer registries of Colorado and New Mexico, upon IRB approval at the 
respective site. 
 
3.0 Multi-Site Research Communication & Coordination  
Not Applicable  
 
3.1 Non-Rutgers Site Research 
Not Applicable  
 

 
 
 
Protocol Number: 2018001350 
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4.0 Research Data Source/s 
 
4.1 Primary Data: Subjects and Specimens 
4.2 Subject Selection and Enrollment Considerations  
A. Recruitment Details – New Jersey State Cancer Registry – Cancer Surveillance Research Program (NJSCR-CSRP) 
Subjects are recruited through contact by the NJSCR-CSRP, following their established Standard Operating 
Procedures (NJSCR Data Repository #Pro20140000992).  
 
Recently diagnosed cases will be identified by staff at the NJSCR and reviewed by a Certified Tumor Registrar (CTR) 
for study eligibility (Table 1).  We will update address information for the case and the physician of record. Each 
person will be assigned an arbitrary study ID and imported into the study tracking database “CRIMSoN.”  NJSCR 
staff will send a letter to the patient’s diagnosing physician of record to notify the physician that his/her patient 
is eligible for participation in the study.  Physicians are asked to notify NJSCR if the patient should not be contacted 
for participation (i.e., deceased). Two weeks after the physician letter is mailed, NJSCR staff will send the eligible 
patient a packet of study materials. 
 
One week (or five business days) after the initial mailing, staff at the NJSCR will conduct six to eight follow-up 
phone calls at varying times of the day and different days of the week with at least one evening call made between 
the hours of 5-8pm and at least one call made on a weekend. Those reached by phone will be given the option to 
provide a verbal consent to be contacted, which will be recorded in the tracking database. A Spanish-speaking 
NJSCR staff member will contact individuals who indicated Spanish as a preferred language during patient contact.  
Additional recruitment packets will be mailed upon patient request or if returned for an incorrect address. NJSCR 
will track all contact with the patient using the CRIMSoN tracking database.   
 
B. Source of Subjects  
Eligible subjects are sourced directly through the New Jersey State Cancer Registry. 
 
C. Method to Identify Potential Subjects 
Subjects will be identified from the New Jersey State Cancer Registry using established methods, by a highly 
trained Research Scientist using the study inclusion criteria below. 
 
D. Subject Screening 
The NJSCR will identify women recently diagnosed breast and ovarian cancer who meet the inclusion/exclusion 
criteria in Table 1. 
 
Inclusion Criteria – Breast or Ovarian Cancer diagnosis as defined in Table 1. 
 
 
Exclusion Criteria - Exclusion criteria include not being able to speak or read English, not a resident of New 
Jersey at the time of diagnosis, or currently enrolled in an active patient contact study with NJSCR-CSRP. See 
Table 1. 
 
E. Recruitment Materials  
The eligible patient will be sent a packet of study materials, including: 
1. An introductory letter containing a brief description of the study (English or Spanish), a statement of how 
the patient was determined to be eligible for inclusion into the study, a statement of how the patient was 
identified via the NJSCR, and a request for the patient’s participation; 
2. Two copies (one to sign and return, one to keep) of an “agreement to contact” sheet that contains all 
aspects of informed consent and a location to sign; 

 
 
 
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3. An information sheet that contains all aspects of HIPAA; 
4. An NJSCR Study FAQ brochure which aims to answer common questions about the NJSCR and study 
participation; and, 
5. A postage paid return envelope for the completed Agreement to Contact form. 
 
 
      Materials will be translated to Spanish after English materials are approved. 
 
 
Lead Site Recruitment Methods – Not Applicable 
 
4.3 Subject Randomization 
NJSCR will not be involved in the randomization process.  Briefly, the Principal Investigator (Dr. Kinney) will randomize 
consenting women to one of 3 intervention arms using block randomization – (1) Usual care, (2) Mailed Targeted Print, 
and (3) Telephone Counseling and Navigation.  Randomization will be single blinded.  Research team members who are 
assessing the outcomes will be blinded to study arm assignment.  Research staff who are conducting follow-up interviews 
will be blinded to group assignment as much as possible.  At the beginning of the follow-up interviews, the interviewer 
will request that the participant does not reveal the study arm they were assigned to. 
 
4.4 Secondary Subjects 
Not Applicable  
 
4.5 Number of Subjects 
A. Total Number of Subjects 
In New Jersey, we will contact 7,000 breast and ovarian cancer survivors to obtain 700 consents, expecting that 
50% of identified individuals sampled and screened for eligibility will fall under our exclusion criteria or will be 
ineligible for other reasons, 25-28% will consent, and we will retain 80% over the course of the study. 
B. Total Number of Subjects If Multicenter Study – Not applicable 
 
4.6 Consent Procedures 
A. Consent 
 Documenting Consent 
NJSCR will obtain consent for contact and document consent using a form and tracking the 
information in CRIMSoN patient tracking database. 
 Waiver of Documentation Of Consent - Consent will be taken over the telephone by Rutgers Cancer 
Institute of New Jersey study staff. The subjects will be asked to sign the HIPAA and return it to the 
CINJ staff members. During COVID 19 they will return the consent form to a staff member with the 
address included on the return envelope. These HIPAA consent forms will be stored in a locked safe 
and transferred back to Rutgers CINJ following the COVID 19 pandemic.   
  Waiver or Alteration of Consent Process - Not Applicable  
 Destruction of Identifiers - Not Applicable  
 Use of Deception/Concealment - Not Applicable  
B. Consent Process 
 
Location of Consent Process 
The consent process will begin by mail for all participants. Participants will receive a 
recruitment letter announcing the study and inviting participation. The consent to contact contains a 
brief description of the study. The process will continue at the start of the survey. A consent script will 
be read to the subject over the phone. All options contain the appropriate contact information if the 

 
 
 
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subject has any questions.  If the woman prefers to provide a verbal consent at the time of follow-up, 
NJSCR will document the verbal consent. 
 
 
Roles for Individuals Involved in Consent 
Consent will be obtained by NJSCR staff. The staff has extensive training, supervision, and 
experience in obtaining consent. 
 
 
Coercion or Undue Influence 
All potential subjects are informed that their participation is voluntary. They are also told that any 
current or future health care will not be affected if they choose not to participate. 
 
4.7 Special Consent/Populations 
 
A. Minors-Subjects Who Are Not Yet Adults - Not Applicable 
 
Criteria for Consent of Minors- Not Applicable  
 
Wards of the State - Not Applicable 
 
Parental/Guardian Permission - Not Applicable 
 
Assent Process - Not Applicable 
 
B. Non-English Speaking Subjects 
 
All recruitment materials, surveys, and intervention materials will be available to participants in English 
or Spanish, depending on their preference. The TCN session will be conducted in English or Spanish, 
depending on the participant’s preference. Spanish materials will be submitted to the IRB after the English 
materials have been approved. To facilitate communicate between Spanish speaking participants and 
study staff, participants and study staff may also use over the phone translation services.  
 
.Process for Non-English Speaking Subjects 
The New Jersey State Cancer Registry database indicated Hispanic ethnicity.  If a person is Hispanic, then 
they will receive English and Spanish materials.  NJSCR has a Spanish-speaker on staff (Ms. Nunez) who is 
available to speak with Spanish-speaking subjects for the consent / Agreement to Contact.   
 
C. Economic Burden and/or Compensation for Subjects 
 Expenses  
There is no cost for participation in the study. 
 Compensation/Incentives 
Compensation will be offered in consideration of the time spent participating in each phase and is 
estimated to be 45-60 minutes per survey. Participating women will receive a $50 gift card for each 
survey that they complete, totaling 4 surveys or $250. 
 
D. Risks and Benefits to Subjects 
 
Description of Subject Risk 
This study is expected to be of minimal risk to participants. The study involves consent to participate in 
research studies. The greatest risk involved is the loss of confidentiality.  See Provisions to Protect the 
Privacy Interests of Subjects section below. 
   
 
Risks to Non-Subjects - Not Applicable 
 
 
Minimizing Risks 

 
 
 
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The greatest risk in the study is the loss of privacy. This is minimized using de-identified data (see 
Provisions to Protect the Privacy Interests of Subjects below). 
 
 
Certificate of Confidentiality (CoC) –  
To help us protect privacy, we have obtained a Certificate of Confidentiality from the National Institutes 
of Health. The researchers can use this Certificate to legally refuse to disclose information that may 
identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, 
for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands 
for identifying information. The Certificate cannot be used to resist a demand for information from 
personnel of the United States Government that is used for auditing or evaluation of federally funded 
projects or for information that must be disclosed in order to meet the requirements of the federal Food 
and Drug Administration (FDA).  The Certificate of Confidentiality will not be used to prevent disclosure 
to state or local authorities of harm to self or others.  
 
 
Potential Benefits to Subjects 
Although the risks to participants are minimal, the personal and familial benefits are that all participants 
will be provided with education via print material and those in the TPN arm, will receive behavior change 
counseling and patient navigation. At 6-months, the study will offer to cover the costs of CGRA for all 
enrolled women across all study arms, should they desire these services. 
 
 
Provisions to Protect the Privacy Interests of Subjects 
The NJSCR has established policies and procedures governing the use of cancer surveillance data for 
research including physical access controls, data access controls, and confidentiality and CITI training. On 
occasion, a cancer patient that has been contacted by the NJSCR for participation in such observational 
research studies will express concern about his/her cancer diagnosis information being included in the 
statewide cancer registry. All NJSCR staff are trained in the proper procedures to discuss the state-
mandated collection of cancer diagnosis information. If the cancer patient expresses discontent over 
being contacted for inclusion in research studies, the NJSCR staff member will offer the option for the 
patient to be placed on a “Do Not Contact for Research” list. The patient will no longer be contacted for 
any research studies. 
 
 
Research Team Access To Subject Data 
The NJSCR will obtain consent to be contacted prior to transferring identifiers to the investigators.  The 
NJSCR will extract selected independent variables from the cancer registry for participants that consent 
to NJSCR.  All computers are password protected and in a secure office.  The database holding PII is 
password protected also and is restricted to NJSCR-CSRP research staff.  All electronic files are saved on a 
secure, encrypted server.  Paper files are secured in locked file cabinets in the locked office.   
 
4.8 Secondary Data - Not Applicable 
A. Chart/Record Review Selection - Not Applicable 
B. Secondary Specimen Collection - Not Applicable 
 
5.0 Special Considerations 
 
5.1 Health Insurance Portability and Accountability Act (HIPAA) 
NJSCR is a non-HIPAA covered entity. 
 

 
 
 
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5.2 Family Educational Rights and Privacy Act (FERPA) - Not Applicable 
 
5.3 NJ Access to Medical Research Act - Not Applicable 
 
5.4 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) - Not Applicable 
 
6.0 Research Data Protection and Reporting 
 
6.1 Data Management and Confidentiality 
A. Data Analysis Plan 
Participants will be randomized into the 3 arms using block randomization. Analyses will be conducted with SAS 
9.4 and R 3.2 or updated versions. Outcome variables, along with baseline and follow-up (as applicable) 
demographic, clinical and psychosocial factors described above, will be summarized by study arm using standard 
descriptive statistics such as means (standard deviations) for continuous variables and tabulations for categorical 
variables. Although we do not anticipate baseline differences in the distribution of measured factors between the 
randomly assigned arms, we will assess for statistical differences using appropriate parametric and non-
parametric tests. While the specific aims along with the analyses are described below, some of the analytical 
strategies across the aims are described as follows: 1) The key study outcomes will be reported that account for 
missing data using multiple imputation and intent-to-treat (ITT) approaches. Multiple imputation under the 
Missing at Random assumption will be applied using a Markov Chain Monte Carlo method186 via PROC MI in SAS, 
given the expected pattern of non-monotonic missing data. A post hoc approach will address the influence of 
missing not at random (MNAR) and the effect of attrition on outcomes of interest. Sensitivity analyses will be 
performed to assess alternative multiple imputation techniques upon the extent of MNAR influences. 2) 
Multiplicity will be adjusted for the primary outcome analysis using the Holm’s adjustment procedure, which 
guarantees strong error control.187 The SAS MULTTEST procedure will be used with the marginal p-values. For 
secondary endpoints, no multiplicity adjustment is considered. All tests will be two-sided. The effect sizes and 95% 
confidence intervals (CIs) of all outcomes using both ITT, per protocol, and multiple imputed data will be reported 
regardless of statistical significances.  
 
Analytic Plan for Addressing Specific Aims: Aim 1 is to test the hypothesis that compared to UC, medical record 
verified CGRA uptake at 6 months, as the primary outcome, will be highest among women participating in the TCN 
arm followed by women participating in the TP arm. The proportion and its 95% confidence interval (CI) of CGRA 
uptake for each arm will be calculated using Wilson score interval or the exact binomial CI of Clopper and Pearson 
method, depending on the data skewness or sample sizes at each time and ethnic and geographic subgroups. For 
the primary outcome analysis, logistic regression modeling will be employed with the main covariate of arm to 
estimate an odds ratio (OR) along with a 95% CI. As needed, we will report an adjusted OR, controlling for 
confounding factors. Potential confounds include age in years, cancer diagnosis site (breast, ovarian or both), 
family cancer history (yes vs. no), at-risk first-degree relatives (yes vs. no), education level (< high school, high 
school diploma, >= college), household income (low: below the median income vs. high or as appropriate), time 
since diagnosis (<5 years, 6-10 years, > 10 years), health insurance (yes vs. no), geographic residence (rural vs. 
urban), state (NM vs. CO), health literacy (continuous or categorical levels), ethnicity (Hispanic vs. Non-Hispanic), 
primary language (English vs. Spanish); other psychological, sociocultural and demographic factors will be adjusted 
as needed. We will also compare the 3 study arms with regard to medical record verified CGRA uptake by 12 
months (secondary outcome) after offering to cover the costs of CGRA following the 6-month survey for those 

 
 
 
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who desire but did not access CGRA. Evaluation of the incremental effect will be assessed by comparing the 
difference of the primary outcome between changed intervention arms (UC to TP/TCN; TP to TCN). For those that 
availed themselves of “free” CGRA provided through the study, we will describe patient preferences by study arm 
and other factors (e.g., age, ethnicity, residence area, education, income, literacy, psychosocial factors, and 
language preference). Model selection with multiple variables will be conducted using AIC and BIC approximation 
criteria, while including theoretically and practically relevant variables. Aim 2 tests whether there are differences 
across the 3 study arms with regard to uptake of genetic testing for HBOC at 6 and 12 months. Similar to Aim 1, 
multivariable regression modeling approach will be performed for the binary outcome (genetic testing yes vs. no) 
with the main covariate of arm and other confounding variables at each time point. Then, generalized linear mixed 
effects model (GLMM) will be employed for the two time point outcomes, using binomial distribution with logit 
link function and adjusting for the correlation within the same subjects to estimate the behavior trend over time. 
Aim 3 compares cognitive and affective intermediate endpoints among women in the 3 study arms and explores 
potential underlying theoretical mediating and moderating mechanisms that will further specify and elucidate 
significant 6-month and 12-month intervention effects, if such effects are observed. The study arms will be 
compared with regard to beliefs (threat and efficacy), informed decision making indicators (knowledge, decisional 
conflict, and decision regret) and emotional factors (cancer worry and fear). Arm comparisons will be based on 
differences in least-square mean changes from baseline to 6 months (including values from the 1-month survey) 
from an analysis of covariance model containing terms for study arm with baseline scores for as a covariate. 
Structural equation modeling (SEM) for the hypothesized meditational pathways will be conducted with the 
procedure of CALIS in SAS and the ‘sem’ package in R. Before the SEM, all variables in the modeling will be centered 
with means zero. The SEM will focus on (1) specifying structural equation models; (2) interpreting the model fit 
statistics and estimation results; (3) testing model with the arms; and (4) analyzing direct and indirect effects. 
Mediators of intervention effects include threat appraisals, response efficacy, self-efficacy, knowledge, 
recommendation about CGRA measured at one-month post intervention. Several indices will be used to assess 
the adequacy of overall model fit: Comparative Fit Index, Standardized Root Mean-Square Residual, and Root-
mean Square Error-of Approximation.188 The interventions may not be beneficial for all study participants. Thus, 
sensitivity/moderation analysis will be done to identify subgroups for which the intervention has or does not have 
an effect (e.g., age, diagnosis, time since diagnosis, rural/urban, education level, literacy, acculturation, language 
preference, close at-risk relative, household income, familism, family support of CGRA, provider recommendation, 
and cost, travel and time barriers). This will provide important information about subgroups who are particularly 
receptive or resistant to the effect of each intervention.  
Economic Analysis:  Aim 4 will measure the incremental cost of implementing the interventions from a payer and 
societal perspective. The payer in this case would be the entity responsible for funding the cancer registry 
considering patient ascertainment and intervention implementation; therefore, we will estimate recruitment 
costs, intervention development and delivery costs and downstream costs up to 1-year post intervention. The 
societal perspective in theory includes all goods and services consumed as a result of the intervention, including 
the payer costs and patient costs: deductibles, copayments, and cost-sharing for direct medical goods and services 
in addition to direct non-medical goods and services such as transportation to appointments, and indirect, or 
opportunity costs incurred as part of the intervention.189 We will use micro-costing techniques as recommended 
by the US Panel on Cost-Effectiveness in Health and Medicine190 and utilized in our past research on the costs of 
behavioral interventions.54,178,179 Implementation costs will include labor (e.g., registry and study staff, MI trainer, 
health education specialists) and non-labor (e.g., printing, mailing, costs of CGRA and genetic tests, telephone 

 
 
 
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charges, patient-related travel time). Costs will be grouped as variable and fixed costs. We focus on costs of 
replicating delivery of the intervention and the immediate down-stream consequences (e.g., obtaining CGRA and 
genetic testing). Costs will be estimated via direct elicitation from participants and medical records to assign fixed 
price weights. We consider the following outcomes based on a priori trial specifications: 1) average cost per 
patient for ascertainment, scheduling, health education specialist-participant interaction time; 2) average cost per 
CGRA and genetic testing; and 3) average time spent with health education specialist. We will also examine overall 
health care use (including, visits to genetic professionals and other providers, and genetic testing) by study arm 
(and covariates as needed) at 6 months and 12 months. The incremental cost-effectiveness of one method over 
another is derived from using the following formula: Incremental cost-effectiveness A = (CA – CB )/(EA –EB) where CA 
and CB refer to average total costs of each alternative and EA and EB refer to average total effectiveness for each 
alternative. The resulting incremental cost effectiveness ratio (ICER) calculated for each combination of 
comparators, TCN, TP, and UC, can be used to assess the value provided by alternative A when compared to 
alternative B, as it represents the investment required for each additional unit of effect gained. All analyses of 
cost and effectiveness will be completed on an intent-to-treat basis. Uncertainty in estimates will be tested using 
probabilistic modeling and sensitivity analysis to assess key drivers of results such as rural/urban residence, cancer 
type, ethnicity, language preference, age, education, household income and family composition (have at least one 
living at risk first-degree relative).191 Uncertainty in the ICER will be evaluated using cost-effectiveness 
acceptability curve plots.192 
Additional analysis: We will apply the RE-AIM framework to assess reach and effectiveness, implementation and 
adoption issues overall and by ethnic and geographic subgroup, as well as socioeconomic status and cultural 
variables (e.g., language, medical mistrust).193-195 We will describe adherence to the theoretical aspects of the 
intervention and brief MI using MITI global scores.133 We will also explore whether process variables (dose and 
timing of health education specialist-participant interactions, intervention fidelity and intervention reactance 
measures) influence CGRA uptake at 6 and 12 months. Additionally, implementation issues will be assessed, 
including health education specialist learning needs and challenges related to counseling and navigation. Content 
and thematic analysis will be employed to evaluate responses to open-ended questions about barriers and 
facilitators to CGRA and genetic testing, preferences regarding CGRA and perceptions about the interventions and 
overall study experience.196 Two coders (AK & KF) code data and inter-rater reliability will be reported.  
B. Power Analysis 
The sample size and power evaluation for the proposed study was based on the primary outcome analysis. Given 
the study’s hypothesis that the TCN intervention will have greater effects over both the UC and TP arm, we believe 
a minimum 12% difference on CGRA uptake 6 months between any intervention arm would be significant from a 
public health perspective.197 We expect no greater than 7% CGRA uptake by 6 months in UC, with at least 12% 
increments for TP and TCN, respectively. With the adjusted significance level of 0.017 (alpha) for the multiple 
comparisons using  
Holm’s correction, 182 participants per study arm will provide 95.7% power to detect a 15% difference in the 
CGRA uptake 6 months between the UC and TP arms. For the comparison between TP and TCN, 182 patients per 
arm will provide 84.5% power to detect a 15% difference (19% vs. 34%) at the adjusted 0.025 alpha level using 
the two-sided Likelihood Ratio test. For the secondary analysis, we expect at least 80% power to assess the 
interventions’ effects on ~10-12% change to 15% differences in genetic testing uptake, and small to medium effect 
sizes of psychosocial targets between the study arms given the measures’ standard deviations since our final 

 
 
 
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sample size per arm of 182 exceeds the planned final sample size of 164. Randomizing 548 participants based on 
1:1:1 relative sizes ensures > 80% power for all contrasts. Assuming up to 20% attrition after baseline assessment, 
we will recruit 182 individuals for each arm. The sample size and power was evaluated using PASS13 software.198   
A total of 548 individuals will be required (182 per arm x 3 arms).  NJSCR will recruit 700 individuals and the 
remaining sample size will be obtained from other participating registries. 
C. Securing the Data  
All computers are password protected and in a secure office.  The database holding PII is password protected 
also and is restricted to NJSCR-CSRP research staff.  To protect personal identifiers, each woman will be 
assigned an arbitrary identification number and this will be used for communication between research staff.  
Any PII that is consented to be released will be transferred in a secure, encrypted manner.     
 
All electronic data are saved on a secure, encrypted server and backed up regularly on a secure server.  Paper 
files are secured in locked file cabinets in the locked office.  
 
At the Prime Site, the Principal Investigator (Dr. Kinney) will provide each study participant with a Registry 
Identifier and Participant Identifier. Data will be linked by these two keys. Names and birthdates (and other 
PHI) that could be used to identify individuals will not be entered into the main study database. These data will 
be stored in an excel file which will be kept separate from research data. As aforementioned, the 
biostatisticians who analyze the data will be blinded to participant’s study arm.   
 
Data for this study, including PIII, will be stored by NJSCR for 6 years after study completion as required by the 
Rutgers IRB. 
 
D. Data Quality Control 
Quality Control – The CRIMSoN patient tracking database will reviewed regularly to assure quality.   
 
E. Data Handling  
At the New Jersey State Cancer Registry, the Site Principal Investigator (Dr. Stroup) will be responsible for 
data protection and handling.  All data will be stored indefinitely.  Only authorized and trained research staff 
will have access to the data and will be responsible for the transmission of the data.  Any PII for consented 
cases will be shared with the Principal Investigator using Rutgers LiFT, or another large file encryption 
mechanism. 
 
6.2 Data Security 
The workflow has been designed to limit access to the link between identifiers and the study ID (see Research 
Design, section h). Access to data will be limited to study personnel. All computers on which analyses will be 
conducted will be password protected and will be further protected by the Rutgers firewall and malware 
protection. All data will be transferred using a secure file transfer system (encrypted file, encrypted email, or 
secure file transfer protocol). Paper copies of raw data will not be produced. Only aggregate results will be 
published. 
 
6.3 Data and Safety Monitoring – Not Applicable 
 
6.4 Reporting Results 
A. Sharing of Results with Subjects – Not Applicable 

 
 
 
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B. Individual Results – Not Applicable 
C. Aggregate Results  
Aggregate results will be published in scientific journals and abstracts will be presented at scientific meetings.  
Abstracts will be posted on the NJSCR website for the public and participants to read.  Participants who request 
copies of scientific findings will be sent any published journal articles. 
D. Professional Reporting 
Investigators will also comply with policies and procedures governing the publication of finding from research 
utilizing NJSCR data, as well, Dr. Stroup and all co-authors will be given opportunity review any 
abstract/manuscript prior to its submission or use. 
 
Significant contributions to the field of genetics screening will be reported through: 
 
Poster and/or oral presentations submitted for professional meetings  
 
Summarized tables described in manuscripts for submission to professional journals such as Cancer 
 
7.0 Data and/or Specimen Banking 
A. Storage Methods – Not Applicable 
B. Storage Data – Not Applicable 
C. Releasing Data/Specimens – Not Applicable 
 
8.0 Other Approvals/Authorizations 
This study has approval by the University of New Mexico Comprehensive Cancer Center and the Colorado 
Central Cancer Registry as collaborating sites. 
 
9.0 Bibliography 
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Walker JL, Powell CB, Chen LM, et al. Society of Gynecologic Oncology recommendations for the prevention of 
ovarian cancer. Cancer. 2015. 
4. 
Pal T, Vadaparampil ST. Genetic Risk Assessments in Individuals at High Risk for Inherited Breast Cancer in the 
Breast Oncology Care Setting. Cancer Control. 2012;19(4):255-266. 
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Domchek SM, Bradbury A, Garber JE, Offit K, Robson ME. Multiplex genetic testing for cancer susceptibility: out 
on the high wire without a net? 2013;31(10):1267-1270. 
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Bradbury AR, Patrick-Miller L, Long J, et al. Development of a tiered and binned genetic counseling model for 
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Maxwell KN, Wubbenhorst B, D'Andrea K, et al. Prevalence of mutations in a panel of breast cancer 
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Kuchenbaecker KB, Ramus SJ, Tyrer J, et al. Identification of six new susceptibility loci for invasive epithelial 
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Easton DF, Pharoah PD, Antoniou AC, et al. Gene-panel sequencing and the prediction of breast-cancer risk. N 
Engl J Med. 2015;372(23):2243-2257. 
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Minion LE, Dolinsky JS, Chase DM, Dunlop CL, Chao EC, Monk BJ. Hereditary predisposition to ovarian cancer, 
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Collins FS, Varmus H. A new initiative on precision medicine. N Engl J Med. 2015;372(9):793-795. 

 
 
 
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12. 
Couch FJ, Hart SN, Sharma P, et al. Inherited mutations in 17 breast cancer susceptibility genes among a large 
triple-negative breast cancer cohort unselected for family history of breast cancer. 2015;33(4):304-311. 
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Slavin TP, Niell-Swiller M, Solomon I, et al. Clinical Application of Multigene Panels: Challenges of Next-
Generation Counseling and Cancer Risk Management. Frontiers in oncology. 2015;5:208. 
14. 
Nelson HD, Pappas M, Zakher B, Mitchell JP, Okinaka-Hu L, Fu R. Risk assessment, genetic counseling, and 
genetic testing for BRCA-related cancer in women: a systematic review to update the U.S. Preventive Services 
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http://napbc-breast.org/standards/2013standardsmanual.pdf. NAPfBC. Genetic Evaluation and Management 
2014, December 2015. 
16. 
Radford C, Prince A, Lewis K, Pal T. Factors which impact the delivery of genetic risk assessment services focused 
on inherited cancer genomics: expanding the role and reach of certified genetics professionals. Journal of 
genetic counseling. 2014;23(4):522-530. 
17. 
Robson ME, Bradbury AR, Arun B, et al. American Society of Clinical Oncology Policy Statement Update: Genetic 
and Genomic Testing for Cancer Susceptibility. 2015;33(31):3660-3667. 
18. 
Hiraki S, Rinella ES, Schnabel F, Oratz R, Ostrer H. Cancer risk assessment using genetic panel testing: 
considerations for clinical application. Journal of genetic counseling. 2014;23(4):604-617. 
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Domchek SM, Friebel TM, Singer CF, et al. Association of risk-reducing surgery in BRCA1 or BRCA2 mutation 
carriers with cancer risk and mortality. Jama-J Am Med Assoc. 2010;304(9):967-975. 
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Daly MB, Pilarski R, Axilbund JE, et al. Genetic/familial high-risk assessment: breast and ovarian, version 1.2014. 
Journal of the National Comprehensive Cancer Network : JNCCN. 2014;12(9):1326-1338. 
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Mavaddat N, Peock S, Frost D, et al. Cancer risks for BRCA1 and BRCA2 mutation carriers: results from 
prospective analysis of EMBRACE. J Natl Cancer Inst. 2013;105(11):812-822. 
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Cragun D, Pal T. Identification, Evaluation, and Treatment of Patients with Hereditary Cancer Risk within the 
United States. ISRN Oncol. 2013;2013:260847. 
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Runowicz CD, Leach CR, Henry NL, et al. American Cancer Society/American Society of Clinical Oncology Breast 
Cancer Survivorship Care Guideline. 2015. 
24. 
Lokich E, Stuckey A, Raker C, Wilbur JS, Laprise J, Gass J. Preoperative genetic testing affects surgical decision 
making in breast cancer patients. Gynecologic oncology. 2014;134(2):326-330. 
25. 
Finch A, Wang M, Fine A, et al. Genetic testing for BRCA1 and BRCA2 in the Province of Ontario. Clinical genetics. 
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Armstrong J, Toscano M, Kotchko N, et al. Utilization and Outcomes of BRCA Genetic Testing and Counseling in a 
National Commercially Insured Population: The ABOUT Study. JAMA oncology. 2015;1(9):1251-1260. 
27. 
Drohan B, Roche CA, Cusack JC, Hughes KS. Hereditary Breast and Ovarian Cancer and Other Hereditary 
Syndromes: Using Technology to Identify Carriers. Ann Surg Oncol. 2012;19(6):1732-1737. 
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Febbraro T, Robison K, Wilbur JS, et al. Adherence patterns to National Comprehensive Cancer Network (NCCN) 
guidelines for referral to cancer genetic professionals. Gynecologic oncology. 2015;138(1):109-114. 
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