Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors (AH-HA)
Phase: NA
Conditions: Breast Neoplasm, Prostatic Neoplasm, Colorectal Neoplasms, Endometrial Neoplasms, Hodgkin Disease, Non Hodgkin Lymphoma
Sponsor: Wake Forest University Health Sciences

Official Title:  Wake Forest NCORP Research Base – Assessing Effectiveness and 
Implementation of an EHR Tool to Assess Heart Health Among Survivors – Coordinating Center 
NCT03935282 
Version Date: 09/28/2022 

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COVER PAGE 
 
 
 
 
 
DCP Protocol #: 
WF-1804CD  
 
Local Protocol #: WF-1804CD  
 
Assessing Effectiveness and Implementation of an EHR Tool to Assess  
Heart Health Among Survivors (AH-HA) 
 
Consortium Name: 
 
 
Wake Forest NCORP Research Base  
Name of Consortium Multi-  
Glenn J. Lesser, MD  
Principal Investigator: 
 
Louise McMichael Miracle Professor of Oncology 
 
 
 
 
 
Wake Forest School of Medicine  
 
 
 
 
 
Department of Internal Medicine 
Section on Hematology and Oncology  
Medical Center Boulevard  
Winston-Salem, NC  27157 
Telephone: (336) 716-0891 
Fax: (336) 716-6275 
E-mail address: glesser@wakehealth.edu 
 
Consortium Name: 
 
 
Wake Forest NCORP Research Base 
Name of Consortium Multi-  
Kathryn Weaver, PhD, MPH  
Principal Investigator: 
 
Professor of Public Health Sciences 
 
 
Department of Social Sciences & Health Policy   
 
 
Medical Center Boulevard  
 
 
Winston-Salem, NC 27157  
 
 
Telephone: (336) 713-5062  
 
 
Fax: (336) 716-7554  
 
 
 
 
 
E-mail address: keweaver@wakehealth.edu 
 
Organization Name:  
 
Wake Forest School of Medicine 
Protocol Principal Investigator: Kathryn Weaver, PhD, MPH  
 
 
Professor of Public Health Sciences 
 
 
Department of Social Sciences & Health Policy   
 
 
Medical Center Boulevard  
 
 
Winston-Salem, NC 27157  
 
 
Telephone: (336) 713-5062  
 
 
Fax: (336) 716-7554  
 
 
 
 
 
E-mail address: keweaver@wakehealth.edu 
 
Organization: 
Washington University in St. Louis* 
Protocol Co-Principal 
Randi Foraker, PhD, MA, FAHA 
Investigator: 
General Medical Sciences, Institute for Informatics 
4444 Forest Park Avenue 
St. Louis, MO 63110 
Telephone: (314) 273-2211 
Fax: (314) 273-1390 
E-mail address: randi.foraker@wustl.edu 
 
 

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Organization:  
 
 
Wake Forest School of Medicine 
Co-Investigator: 
 
 
Brian Wells, MD, PhD 
 
 
 
 
 
Associate Professor of Public Health Sciences 
 
 
 
 
 
Department of Biostatical Sciences 
 
 
Medical Center Boulevard 
 
 
 
 
 
Winston-Salem, NC 27157 
 
 
 
 
 
Telephone: (336) 416-5185 
 
 
 
 
 
Fax: (336) 713-5308 
 
 
 
 
 
E-mail address: bjwells@wakehealth.edu 
 
Organization:  
 
 
Wake Forest School of Medicine 
Co-Investigator: 
 
 
W. Gregory Hundley, MD 
Department of Internal Medicine 
 
Sections on Cardiology and Radiology 
 
Medical Center Boulevard 
 
Winston-Salem, NC 27157 
 
Telephone: (336) 716-0607 
 
Fax: (336) 716-9188 
E-mail address: ghundley@wakehealth.edu 
 
Organization:  
 
 
Wake Forest School of Medicine 
Co-Investigator: 
 
 
Heidi Klepin, MD 
 
Department of Internal Medicine 
 
Section on Hematology and Oncology 
 
Medical Center Boulevard 
 
Winston-Salem, NC 27157 
 
Telephone: (336) 716-7975 
 
Fax: (336) 716-5687 
 
E-mail address: hklepin@wakehealth.edu 
 
Organization:  
 
 
Washington University in St. Louis* 
Co-Investigator: 
 
 
Philip Payne, PhD, FACMI 
 
 
 
 
 
Computer Science and Engineering, Institute for Informatics 
 
 
 
 
 
4444 Forest Park Avenue 
 
 
 
 
 
St. Louis, MO 63110 
 
 
 
 
 
Telephone: (314) 747-6119 
 
 
 
 
 
Fax: (314) 273-1390  
 
 
 
 
 
E-mail address: prpayne@wustl.edu 
 
Organization:  
 
 
Washington University in St. Louis* 
Co-Investigator: 
 
 
Albert Lai, PhD 
 
 
 
 
 
General Medical Sciences, Institute for Informatics 
 
 
 
 
 
4444 Forest Park Avenue 
 
 
 
 
 
St. Louis, MO 63110 
 
 
 
 
 
Telephone: (314) 747-6119 
 
 
 
 
 
Fax: (314) 273-1390 
 
 
 
 
 
E-mail address: amlai@wustl.edu 
 
Organization:  
 
 
University of Texas Southwestern Medical Center* 
Co-Investigator: 
 
 
Simon Craddock Lee, PhD 
 
 
 
 
 
Clinical Science 

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5323 Harry Hines Boulevard 
 
 
 
 
 
Dallas, TX 75390 
 
 
 
 
 
Telephone: (214) 648-2410 
 
 
 
 
 
Fax: (214) 648-3934 
 
 
 
 
 
E-mail address: simoncraddock.lee@utsouthwestern.edu 
 
Organization:  
 
 
Wake Forest School of Medicine 
Statistician: 
 
 
 
Emily Dressler, PhD 
 
 
 
 
 
Associate Professor of Public Health Sciences 
 
 
 
 
 
Department of Biostatistics and Data Science 
 
 
Medical Center Boulevard  
 
 
Winston-Salem, NC 27157  
 
 
Telephone: (336) 713-0917 
 
 
Fax: (336) 713-5308 
 
 
 
 
 
E-mail address: edressle@wakehealth.edu 
 
 
*No participant accruals occur at this site 
¥ Wake Forest Baptist Comprehensive Cancer Center Qualitative and Patient-Reported Outcomes will 
conduct all interviews for non-patient participants through NC002. 
 
 
Grant #:  R01CA226078 
 
Protocol Version Date:   09/28/2022 
Protocol Amendment #: Amendment 6 
 
 
Protocol History: 
 
Initial 
Version 02/12/2019 
Not Activated 
Amendment 1 
Version 04/12/2019 
Activated 05/21/2019 
Amendment 2 
Version 07/22/2019 
Released 12/2/2019 
Amendment 3 
Version 06/05/2020 
Released 08/12/2020 
Amendment 4 
Version 08/13/2021 
Released 09/02/2021 
Amendment 5 
Version 02/10/2022 
Released 04/26/2022 
 
Site Participation will be limited to Wake Forest NCORP Components and Sub-components who meet 
the site eligibility and are randomized using the methods presented in the protocol.   
 
 

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CONTACT INFORMATION 
 
For regulatory requirements: 
For patient enrollments: 
For data submission: 
Regulatory documentation must 
be submitted to the Cancer 
Trials Support Unit (CTSU) via 
the Regulatory Submission 
Portal. 
 
(Sign in at 
https://www.ctsu.org,            
and select the Regulatory >  
Regulatory Submission.)  
 
Institutions with patients 
waiting that are unable to use 
the Portal should alert the 
CTSU Regulatory Office 
immediately by phone or email: 
1-866-651-CTSU (2878), or 
CTSURegHelp@coccg.org to 
receive further instruction and 
support. 
 
Contact the CTSU Regulatory 
Help Desk at 1-866-651-CTSU 
(2878) for regulatory assistance. 
 
Refer to the Participant 
Enrollment section for 
instructions on using the 
Oncology Patient Enrollment 
Network (OPEN). OPEN is 
accessed at 
https://www.ctsu.org/OPEN_SY
STEM/ or 
https://OPEN.ctsu.org. 
 
Contact the CTSU Help Desk 
with any OPEN-related 
questions by phone or email:  
1-888-823-5923, or 
ctsucontact@westat.com. 
Data collection for this study will be 
done through REDCap. Refer to the 
data submission section of the 
protocol for further instructions.  
 
Address: 
Wake Forest NCORP Research Base  
Wake Forest Baptist Medical Center 
Building 525@Vine, 4th floor  
Medical Center Boulevard  
Winston-Salem, NC 27157  
 
Fax:      (336) 713-6476  
Email: NCORP@wakehealth.edu  
 
Do not submit study data or forms to 
CTSU Data Operations. Do not copy 
the CTSU on data submissions. 
 
The most current version of the study protocol and all supporting documents must be downloaded from 
the protocol-specific page of the CTSU members’ website (https://www.ctsu.org).  Access to the CTSU 
members’ website is managed through the Cancer Therapy and Evaluation Program - Identity and Access 
Management (CTEP-IAM) registration system and requires user log on with CTEP-IAM username and 
password.  
For clinical questions (i.e. patient eligibility or treatment-related) contact Wake Forest NCORP 
Research Base (WF NCORP RB) at NCORP@wakehealth.edu. All correspondence will be triaged to the 
appropriate WF NCORP RB representative. 
For non-clinical questions (i.e. unrelated to patient eligibility, treatment, or clinical data submission) 
Contact the CTSU Help Desk by phone or e-mail:  
CTSU General Information Line – 1-888-823-5923, or ctsucontact@westat.com.  All calls and 
correspondence will be triaged to the appropriate CTSU representative.  
The CTSU Website is located at https://www.ctsu.org. 
 

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SCHEMA 
 
Study Population:  Breast, prostate, colorectal, endometrial, or Hodgkin and non-Hodgkin lymphoma 
cancer survivors presenting to 8-12 NCORP practices for post-treatment follow-up care 
 
 
 
Randomization:  
1:1 practice level randomization (4-6 intervention, 4-6 usual care) 
 
 
Intervention:  
Implementation of the Automated Heart-Health Assessment (AH-HA) EHR 
cardiovascular health (CVH) assessment tool and provider education sessions  
 
 
 
Data Collection from Survivors: Baseline (pre & post-visit), 6 months, and 1 year- demographics, referrals 
to health services (including primary care and cardiology), CVH discussions, cardiovascular risk factor data 
 
Data Collection from Key Informants: (after 30 patients are enrolled and 4 weeks after AH-HA 
Implementation) Semi-structured interviews assessing perceptions and perceived impact of the AH-HA tool 
on practices, providers, and survivors; barriers and facilitators to implementing AH-HA into practice; and 
suggested changes to AH-HA to improve future adoption, implementation, and maintenance. 
 
 
 
Primary Endpoint: Cardiovascular health discussions defined as patient-reported discussions with their 
provider for up to seven non-ideal CVH conditions identified for that patient. Conditions include CVH 
factors (cholesterol, blood pressure, glucose/hemoglobin A1c) and CVH behaviors (body mass index, 
smoking, diet, and physical activity). 
 
Study Sample: n=560-700 survivors of breast, prostate, colorectal, endometrial cancers; or Hodgkin and 
non-Hodgkin lymphomas; n=38-42 key informants. 
Study Duration: 1 year 
 
Brief Eligibility Criteria: 
Practices: (1) use of the Epic© EHR, (2) willingness to incorporate the AH-HA tool in their EHR, 
(3) have two or more providers willing to be trained and use AH-HA, and (4) identified providers 
saw ≥100 potentially eligible patients (combined total for all providers) for follow-up in prior 6 
months.  
 
Survivors:  
(1) ≥ 6 months post-potentially curative cancer treatment for breast, prostate, colorectal, 
endometrial cancers, or Hodgkin and non-Hodgkin lymphomas. Ongoing hormonal therapies such 
as tamoxifen, aromatase inhibitors (with or without adjuvant CDK 4/6 inhibitors such as 
abemaciclib), or androgen deprivation are allowed.  
(2) Scheduled for a routine cancer-related follow-up care visit for one of the cancer types listed 
above with an identified AH-HA provider. 
(3) Able and willing to complete a follow-up assessment in one year;  
(4) No evidence of disease at the time of last medical visit for all cancers, except non-melanoma 
skin disease. 

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TABLE OF CONTENTS 
 
COVER PAGE...........................................................................................................................1 
SCHEMA ..................................................................................................................................5 
1. 
OBJECTIVES ...................................................................................................................8 
1.1  
Primary Objective .............................................................................................................................................. 8 
1.2 
Secondary Objectives......................................................................................................................................... 8 
2. 
BACKGROUND ...............................................................................................................8 
2.1  
Cardiovascular Health among Survivors .......................................................................................................... 8 
2.2  
The AH-HA Intervention................................................................................................................................... 9 
2.3 
Rationale ........................................................................................................................................................... 10 
3. 
SUMMARY OF STUDY PLAN ........................................................................................ 12 
4. 
STUDY Practice SITE AND PARTICIPANT SELECTION ................................................... 12 
4.1 
NCORP Practice Inclusion Criteria ................................................................................................................ 12 
4.2 
 Survivor Inclusion Criteria ............................................................................................................................. 15 
4.3 
 Survivor Exclusion Criteria ............................................................................................................................ 15 
4.4 
Rationale for Cancer Type Inclusion .............................................................................................................. 15 
4.5 
Recruitment and Retention Plan...................................................................................................................... 15 
4.6 
Patients:  Inclusion of Racial/Ethnic Minorities ............................................................................................ 18 
4.7  
Key Informant Inclusion Criteria (Intervention Practice Sites Only) ........................................................... 18 
4.8 
Key Informant Recruitment and Retention Strategy (Intervention Practice Sites Only) ............................ 18 
4.9 
Key Informants: Inclusion of Women and Minorities................................................................................... 19 
5. 
STUDY INTERVENTION ................................................................................................ 20 
6. 
STUDY EVALUATIONS AND PROCEDURES.................................................................. 22 
6.1 
Survivor Schedule of Events ........................................................................................................................... 22 
6.3  
Baseline Assessment ........................................................................................................................................ 23 
6.4 
 6 Month and One Year Assessments ............................................................................................................. 24 
6.5   Key Informant Schedule of Events (Intervention sites only)........................................................................... 24 
7.  
CRITERIA FOR EVALUATION AND ENDPOINT DEFINITION ........................................ 26 
7.1    Summary Table of Endpoints, Measures, Measurement Strategies, and Time Points.................................. 26 
7.2 
Primary Endpoint ............................................................................................................................................. 27 
7.3 
Secondary Endpoints ....................................................................................................................................... 27 
7.4 
Off-Study Criteria ............................................................................................................................................ 28 
7.5 
Study Termination............................................................................................................................................ 28 
8. 
REPORTING ADVERSE EVENTS.................................................................................... 28 
9. 
STUDY MONITORING ................................................................................................... 28 
9.1 
Data Management ............................................................................................................................................ 28 
9.2 
Case Report Forms........................................................................................................................................... 29 
9.3 
Source Documents ........................................................................................................................................... 29 
9.4 
Data and Safety Monitoring Plan .................................................................................................................... 29 
9.5 
 Protocol Adherence....................................................................................................................................... 30 
9.6 
Sponsor or FDA Monitoring ........................................................................................................................... 30 
9.7 
Record Retention.............................................................................................................................................. 31 
10. 
STATISTICAL CONSIDERATIONS ................................................................................. 31 
10.1 Study Design/Description................................................................................................................................ 31 
10.2 Randomization/Stratification........................................................................................................................... 31 
10.3 Accrual and Feasibility .................................................................................................................................... 31 
10.4 Primary Objective, Endpoint, Analysis Plan .................................................................................................. 32 
10.5 Secondary Objectives, Endpoints, Analysis Plans ......................................................................................... 34 
10.6 Analysis Plan for Key Informant Interviews.................................................................................................. 35 
10.7 Evaluation of Response ................................................................................................................................... 35 

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11. 
REGISTRATION PROCESS ............................................................................................. 35 
11.1 Investigator and Research Associate  Registration with CTEP .................................................................... 35 
11.2 Cancer Trials Support Unit Registration Procedures..................................................................................... 36 
11.3     Patient Enrollment .......................................................................................................................................... 38 
11.4  Data Submission / Data Reporting.................................................................................................................. 39 
11.5 Informed Consent............................................................................................................................................. 40 
11.6 Other.................................................................................................................................................................. 40 
Appendix A: Virtual Visit Considerations..................................................................................... 41 
REFERENCES......................................................................................................................... 43 

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1. 
OBJECTIVES 
 
The objective of this hybrid effectiveness-implementation study is to examine the effects of the AH-HA tool 
among breast, prostate, colorectal, endometrial, and Hodgkin and non-Hodgkin lymphoma cancer survivors 
(N=560-700) receiving survivorship care in community oncology practices, using a group-randomized trial 
design (4-6 intervention practices and 4-6 usual care practices). Our central hypothesis is that the AH-HA 
tool will increase (1) cardiovascular health (CVH) discussions among survivors and oncology providers, (2) 
referrals and visits to primary care and cardiology (care coordination), and (3) cardiovascular (CV) risk 
reduction and health promotion activities compared to usual care. 
 
1.1  
Primary Objective  
Assess the impact of the AH-HA tool on providers’ efforts to discuss CVH during visits as compared 
to usual care. Cardiovascular health discussions will be defined as patient-reported discussions with 
their provider for any of the seven non-ideal CVH conditions identified for that patient. Conditions 
include CVH factors (cholesterol, blood pressure, glucose/hemoglobin A1c) and CVH behaviors 
(body mass index, smoking, diet, and physical activity).  
1.2 
Secondary Objectives  
 
1.2.1 
Assess the impact of the AH-HA tool on providers’ efforts to: (1) refer survivors to primary care 
and cardiology, and (2) manage CV risk (ordering of CVH-relevant labs and treatments), using 
data from survivor (N=560-700) reports and the EHR at baseline, 6 months, and one year after 
enrollment.  
1.2.2 
Measure the impact of the AH-HA tool on survivors’: (1) completed visits with primary care 
providers and cardiologists, (2) control of CVH factors (cholesterol, blood pressure, 
glucose/hemoglobin A1c) and CVH behaviors (body mass index, smoking, diet, and physical 
activity), (3) perception of CV risk and knowledge of CVH factors, and 4) satisfaction with care 
using data from survivor (N=560-700) reports and the EHR at baseline, six months, and one 
year after enrollment.  
1.2.3 
Examine factors influencing current and future implementation of the AH-HA tool. 1) Assess 
Reach of the AH-HA tool in community oncology practices using EHR data (proportion and 
characteristics of survivors for whom AH-HA is utilized in clinic) and 2) identify potential 
barriers and facilitators to “real-world” delivery of the intervention and ascertain potential 
modifications to maximize Adoption, Implementation, and Maintenance by collecting data from 
providers and practice administrative leaders via semi-structured interviews.  
2. 
BACKGROUND 
 
2.1  
Cardiovascular Health among Survivors 
 
Evidence and Opportunity: Survivors of many common early-stage cancers are now more likely to die of 
cardiovascular (CV) disease than cancer, elevating the importance of addressing cardiovascular health (CVH) 
in routine survivorship care.1-5  Over 90% of survivors have multiple CV risk factors,6 increasing their risk of 
both poor CV and cancer outcomes.7-15 Contributors to heightened CV risk among cancer survivors include: 
(1) shared mechanisms between cancer and CV disease, including inflammation, tobacco, and obesity, 7, 16 
(2) adverse changes in lifestyle factors during cancer treatment (e.g., weight gain),17, 18 and (3) cardiotoxic effects 
of certain cancer treatments.1, 19   

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Burden of CV Risk Factors among Survivors: Few adults (<1%) report ideal 
CVH,7, 8, 20-22 and cancer survivors are no exception.23 Fewer than 17% of cancer 
survivors are non-smokers, exercise, and have a healthy weight.24 Over 85% of 
survivors do not meet the American Heart Association’s (AHA’s) healthy 
standards in multiple CVH components [body mass index (BMI), physical 
activity, diet, smoking, blood pressure, cholesterol, and glucose].6, 25 
Underserved (e.g., racial/ethnic minority or low income) survivors may have 
heightened risk.26-29 Important risk factors – physical inactivity, unhealthy diet, 
obesity, and smoking – are common to CV disease and cancer.7, 30 
 
Cardiotoxic Effects of Cancer Treatment: Common treatments, including 
chemotherapies (e.g., anthracyclines),31-38  trastuzumab,35, 39 hormonal 
treatments,40-42 and radiation38, 43, 44 are linked with CV injury,1, 24 further 
increasing CV disease susceptibility among cancer survivors.19, 42, 45 Cancer 
treatment and recovery can also cause weight gain and decreased physical 
activity, increasing CV disease risk.19, 46 Addressing CVH is critical for all 
cancer survivors, especially those who receive cardiotoxic treatments, to 
mitigate CV-related outcomes.19, 38, 47, 48 
 
CVH is Under-Addressed among Cancer Survivors:26, 49 Despite Institute of 
Medicine (IOM) recommendations for prevention efforts and care coordination 
for cancer survivors,50-52 up to 20% of breast and colorectal survivors may not 
see a primary care provider,53, 54 heightening their risk for lack of preventive 
services and poor comorbidity management.54-56 Claims data reveal that only 31-
39% of breast cancer survivors received cholesterol screening, significantly 
fewer than matched women without breast cancer.56 Ninety percent of 
oncologists in our pilot study (18 of 20) reported CVH discussions to be 
“somewhat” or “very” important; however, 58% “rarely” or “sometimes” 
discuss CVH with their patients. As a result, oncologists make few referrals for 
CV care to primary care and cardiology for guideline-driven follow-up care.25, 
49, 57, 58 Nearly 35% of cancer survivors do not receive assistance from a 
healthcare provider for lifestyle change.3  
 
Need for Improved CV Management: Better CVH among survivors improves 
survival59 and lowers risk of CV disease47, 60, 61 and cancer recurrence.11-15 
Increases in CVH correspond to lower risk of mortality (all-cause,62, 63 CV 
disease,62, 63 and cancer63), and incident CV disease,64 stroke,10 and cancer.7, 9, 65 
Appropriate management of obesity,66, 67 physical activity,68 diet,68, 69 blood 
pressure,30 smoking, and diabetes30 can favorably impact recurrence and overall 
survival in cancer patients.70 Survivors who follow-up with primary care 
providers are more likely to have preventative discussions71 and improved CVH 
monitoring;72 yet only 28% receive follow-up care from both a primary care 
provider and oncologist.57 Survivors seen by cardiologists in specialized CV 
prevention clinics have also seen improvements in cholesterol and blood 
pressure.60 
 
2.2  
The AH-HA Intervention 
 
Impact of Clinical Decision Support Targeting CV-specific Risk is 
Unknown: EHR-based tools can prompt smoking cessation counseling and 
Figure 1. AH-HA tool.26 
 
 
 
 

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referrals,73 facilitate goal-setting among pre-diabetic individuals,74 lower cholesterol,75 improve BMI and 
diabetes status,76 and increase appropriate prescribing.77 Improved patient outcomes through implementation 
of EHR tools are seen in cardiothoracic surgery78 and primary care.76 Available EHR-based tools target 
individual risk factors (e.g., smoking,73 cholesterol75) or specific diseases (e.g., diabetes,74 HIV79). None 
integrate multiple, complementary health behaviors and factors at the point-of-care. CV risk factors rarely 
occur in isolation.80 Automated clinical decision support tools could increase provider adherence to clinical 
guidelines81 and IOM recommendations,50 but have not been tested for CVH in cancer survivorship care.82 
 
The Automated Heart-Health Assessment (AH-HA) Tool Addresses the Complex CVH Needs of 
Survivors: (Figure 1) Our team developed and deployed a novel, easy-to-use, EHR-embedded CVH 
assessment tool that renders a visual, interactive display of CVH risk factors, automatically populated from 
the EHR.76, 83, 84 This tool was first implemented in primary care and now incorporates EHR data on receipt 
of cancer treatments with cardiotoxic potential. We propose to test and evaluate AH-HA in a new setting – 
survivorship care – and expect high rates of usability in our intervention practices given our feedback so far 
from oncologists, cardiologists, and survivors during tool redesign and preliminary testing.  
 
Our State-of-the-art AH-HA Tool Can be Easily Implemented into Clinical Practice and Widely 
Disseminated.85 We designed the AH-HA tool with a multidisciplinary team to integrate seamlessly into 
provider workflow, unlike other EHR-based clinical decision support systems. AH-HA could revolutionize 
survivorship care by allowing an oncologist to quickly: assess survivor CVH (traditional CV risk factors and 
receipt of potentially cardiotoxic treatments) and coordinate appropriate care. We will update AH-HA with 
short- and long-term cardiotoxicity and/or CV risk algorithms, as data become available, and can integrate 
clinical practice guidelines as these are developed. 
 
Clinical Decision Support Tools Continue to Evolve.86 Our AH-HA tool has been tested for ease of use in 
busy practices and facilitates discussions to address CV risk issues. It is also more comprehensive and less 
obtrusive than previous tools. While we will rely on rigorous, tested methodologies to test the effectiveness 
of the AH-HA tool, our emphasis on qualitatively and quantitatively characterizing the reach, adoption, 
implementation, and maintenance of AH-HA will produce novel data to enhance generalizability of our 
findings beyond this specific tool and setting.87 By simultaneously collecting novel data on barriers and 
facilitators to “real-world” implementation, we will inform efforts to disseminate the AH-HA tool and efforts 
to implement other EHR-integrated health assessment/risk tools within community oncology practices in a 
standards-compliant EHR environment.  
 
2.3 
Rationale 
 
Awareness of CVH Can Favorably Change Health Behaviors and CVH Management:88, 89 Data from 
our team and others show that survivors want to have preventative discussions with their oncologists.26 
Although some oncology providers are hesitant to address obesity and exercise in cancer survivors,90 
exercise recommendations by providers increase cancer survivors’ physical activity by up to 30 minutes per 
week.91, 92 Behavioral interventions for weight loss,93 exercise,94 diet,95 and smoking cessation96 – even if 
brief97 – can be successful in improving CVH among cancer survivors.46 For example, the odds of abstinence 
from smoking at 6 months increased 66% with provider lifestyle advice.97 Our preliminary data from an 
EHR-based intervention in primary care show improvements in BMI and diabetes at one year.76 
 
Focus on the Advancement of Connected Health for Cancer: We address the three high-priority research 
areas identified by the President’s Cancer Panel to advance connected health for cancer: (1) Improve 
understanding of how connected health can enable effective teamwork in healthcare, (2) Identify strategies 
to enhance individuals’ engagement in their healthcare, and (3) Develop approaches for using data from 
connected devices in meaningful ways to enhance clinical care.98 Pilot studies of single-practice tool 

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implementation demonstrate improvement in patients’ CVH.76 However, less-studied are practice-,  
provider-, and patient-level factors that may adversely affect intervention fidelity within and across practices. 
A paucity of data exists relative to technology adoption and usage in community practice settings,86 and we 
lack best practices for tool implementation in community settings. Careful implementation and monitoring 
are needed to ensure that such healthcare innovations do not exacerbate disparities in care coordination and 
CVH awareness and outcomes for underserved patients.99, 100 
 
Survivorship Care is an Optimal Time to Address CVH: Our preliminary data indicate that cancer 
survivors have substantial room for improvement in CVH, and the use of our adapted EHR tool is supported 
by survivors and their providers. If successful, the proposed study will generate excellent data to guide future 
AH-HA tool dissemination efforts. We hypothesize that care coordination and awareness of CV disease risk 
are important factors. Our ultimate goal is to improve CVH among the rapidly growing population of cancer 
survivors, currently estimated to be 15.5 million.101 Use of the established NCORP network is efficient and 
provides an excellent opportunity to test our intervention in community oncology settings, where most 
cancer survivors receive care.  
 
Preliminary Data: Our team has extensive, collaborative experience in evaluating the burden of CV risk 
factors among cancer survivors, conducting usability and implementation studies for clinical decision 
support interventions and NCORP feasibility studies. 
 
• 
Prevalence of Adverse CVH is High among Cancer Survivors: We analyzed data from the NCI 
Follow-Up Care Use among Survivors (FOCUS) Study  to characterize the prevalence of CVH and 
preventive health discussions with healthcare providers. Among 5- to 10- year survivors of breast, 
prostate, colorectal and gynecologic cancers (N=1490), 35% reported a history of CV disease. 
Except for current smoking, CV risk factors were more common among cancer survivors than adults 
in general. Of survivors, 62% were overweight or obese, 55% were hypertensive, 21% had diabetes, 
18% were physically inactive, and 5% were current smokers.25 Among survivors with one or more 
risk factors for CV disease, 33% did not report a health promotion discussion with their healthcare 
providers. Few (14%) long-term survivors reported referral to a cardiologist (6% of those without a 
history of CV disease and 29% of those with a CV disease history, p<.0001).25 
 
• 
Successful Tool Integration in Primary Care: Dr. Foraker developed and implemented the 
original AH-HA tool, and tested it for a year among 41 urban primary care providers whose patients 
are of low socio-economic status.84 Providers reported high usability and acceptability within the 
EHR-evaluation domains of content, accuracy, format, ease of use, and timeliness.102 Duration of 
tool use during an appointment was under 3 minutes, and over the test period, there were 390 tool 
views for 410 eligible patients.102 The proportion of obese patients decreased from 47% to 43%, and 
the proportion of normal-weight patients increased from 15% to 19% (average weight loss: 2.7 
kg).102 Thus, the tool was used by busy primary care providers, and suggested effectiveness in 
improving patients’ risk factors for CV disease. 
 
• 
CVH is Overlooked in Cancer Survivorship Care: In our prior studies with oncologists and 
survivors, both consider CVH to be important to address, but is frequently overlooked during post-
treatment survivorship care.20-22 Up to 20% of survivors do not receive primary care services, placing 
them at high risk of missed preventive care opportunities and highlighting the need for improved 
care coordination.23,24  
 
• 
Acceptability among Oncology Providers and Survivors. Drs. Weaver and Foraker conducted 
one-on-one interviews with 14 oncologists within NCORP practices to assess their attitudes and 
beliefs toward the original AH-HA tool.115 Next, they assembled a clinical advisory group of 

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oncologists and cardiologists to redesign the original AH-HA tool for use in survivorship clinics. 
Based on data from systematic reviews11,36,46,100 and expert consensus, eight categories of potentially 
cardiotoxic treatment categories were incorporated.1,41,58,114 They then tested the prototype (Figure 
1) among survivors (N=39) and oncology providers (N=20) to gather data regarding usability and 
acceptability of the enhanced AH-HA tool. Collectively, these data indicate high acceptability of the 
adapted AH-HA tool among survivors and oncology providers. 
 
Preliminary Data from NCORP: There are 42 NCORP and minority-based NCORP community members 
affiliated with the WF NCORP, totaling about 973 individual affiliates/sub-affiliates overall. WF NCORP-
affiliated sites are located in 40 states and Puerto Rico and Guam. Since 1999, WF NCORP (previously 
named Wake Forest CCOP) has recruited 4,557 cancer survivors to clinical studies; 33% were racial/ethnic 
minorities as well as 68% women, 14% rural residents and 26% age 65 or greater. In 2015 and 2017, we 
surveyed NCORP practice groups participating in cancer care delivery research (CCDR) and obtained 
response rates of 87% and 73%, respectively. In the 2017 survey, 94% of practice groups reported having 
an outpatient EHR. Epic© is the most common system, used by 47% of practice groups with an EHR. 
 
3. 
SUMMARY OF STUDY PLAN 
 
In this hybrid effectiveness-implementation group-randomized clinical trial, 4-6 intervention practices 
will receive the AH-HA tool and 4-6 practices will serve as usual care (control) practices without access to 
the AH-HA tool. Providers at each intervention site will be trained to use the tool during routine follow-up 
care with survivors. Enrolled survivors with breast, prostate, colorectal, endometrial, or Hodgkin and non-
Hodgkin lymphoma cancer (N=560-700) will provide baseline data before and immediately after seeing 
their oncology provider and complete 6-month and 1-year study follow-up visits. We will compare changes 
in outcomes from baseline to 1-year in survivors at the intervention and usual care clinics using data from 
survivor self-reports and the EHR. The primary outcome is CVH discussions defined as the number of 
patient-reported discussions with their provider regarding up to seven non-ideal CVH conditions identified 
for that patient during oncology visits. Secondary outcomes include referrals to primary care and cardiology, 
provider efforts to manage CV risk, survivors’ completed visits with primary care providers and 
cardiologists, and control of CVH factors and behaviors. Implementation metrics will be assessed using data 
from the EHR, structured assessments of usability from providers, and semi-structured interviews with 
providers and administrators (n=38-42) at intervention clinics.  
 
4. 
STUDY PRACTICE SITE AND PARTICIPANT SELECTION 
 
4.1 
NCORP Practice Inclusion Criteria 
 
Figure 2 describes the recruitment of NCORP practices. A recruitment e-mail (Site Invitation to Participate) 
and link to an online Preliminary Site Eligibility Screener will be sent to the CCDR Leads and PIs of all 
NCORP community and minority underserved community sites affiliated with the Wake Forest NCORP 
Research Base. CCDR leads or designees will be asked to provide basic information about all affiliates/sub-
affiliates considered or that will be considered for participation. Detailed study information will be provided 
through e-mails, calls, and webinars, as well as follow-up information technology (IT) calls with NCORP 
practice personnel when necessary. Each affiliate/sub-affiliate that is interested in participating will complete 
the Pre-Randomization Site Checklist, including the submission of a Site IT Capacity Letter. CCDR leads 
at each NCORP site will be asked to rank order their eligible practices in preference of participation. The 
study investigators will select a practice from each NCORP site to participate.  
 
The unit of randomization is the NCORP practice (which may comprise one or more affiliates/sub-affiliates 
and must have a single EPIC EHR accessible to all enrolling oncology providers). The Research Base will 

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randomize the eligible practices with a 1:1 allocation. Selected practices may not share clinical personnel or 
EHRs with another participating practice. Practices will be provided with $7,000 in study funds to support 
recruitment and other activities.  
 
NCORP practice inclusion criteria include: 
 
• 
use of the Epic© EHR 
• 
willingness to incorporate the AH-HA tool in their EHR  
• 
have two or more providers willing to be trained and use AH-HA 
• 
identified providers saw ≥100 potentially eligible patients (combined total for all providers) 
for follow-up in prior 6 months 
 
Virtual designated AH-HA appointments are allowed if the site is equipped with a teleconferencing 
platform and if the participant’s survivorship care visit is already scheduled as a virtual visit. For 
intervention sites, the teleconferencing platform must allow the provider to share his/her screen with 
the survivor in order to show the AH-HA tool in the EHR. Please see Appendix A for details related 
to virtual visits. 
 
 

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Figure 2. Practice Recruitment Schema 
 
 
 
 
 
 
 
 

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4.2 
 Survivor Inclusion Criteria 
 
4.2.1  ≥ 6 months post-potentially curative cancer treatment for breast, prostate, colorectal, or endometrial 
cancers or Hodgkin and non-Hodgkin lymphomas. Ongoing hormonal therapies such as tamoxifen, 
aromatase inhibitors (with or without adjuvant CDK 4/6 inhibitors such as abemaciclib), or androgen 
deprivation are allowed.  
 
4.2.2 Scheduled for a routine cancer-related follow-up care visit (for one of the cancer types listed in 
4.2.1) within the next 30 days with a provider participating in the study (in the intervention arm, 
this is a provider who received training to use AH-HA). 
 
4.2.3 Able and willing to complete a follow-up assessment in one year.  
 
4.2.4 Survivors must have no evidence of disease at the time of last medical visit for all cancers, except 
non-melanoma skin disease. 
 
4.2.5 Age ≥18 years.  
 
4.2.6  Able to understand and willing to provide verbal informed consent. 
 
4.3 
 Survivor Exclusion Criteria 
 
4.3.1  Survivors will be excluded if they have a history of cancer recurrence for any cancer other than 
non-melanoma skin disease. 
 
4.3.2 Prostate patients on active surveillance will be excluded. 
 
4.3.3 Survivor does not speak English or Spanish. 
 
4.3.4. Survivors who are currently on another interventional protocol in which cardiovascular risk factors 
(e.g., blood pressure, smoking, diet, physical activity) are being addressed, as per patient self-report 
or research staff members’ knowledge at the time of consent. 
 
4.4 
Rationale for Cancer Type Inclusion 
 
We focus on these cancer types (breast, prostate, colorectal, endometrial, Hodgkin and non-Hodgkin 
lymphomas) because they are common prevalent cancers in the United States survivor population that also 
have an overall 5-year survival that exceeds 50%.103 In addition, potentially cardiotoxic chemotherapy is 
commonly received by these survivors and CV disease is a significant competing cause of death for early 
stage patients with these cancer types.1-5 Survivors with these types of cancer are also likely to receive at 
least some of their care in community settings and are likely to benefit from survivorship care post-treatment. 
 
4.5 
Recruitment and Retention Plan 
 
Local NCORP site staff will obtain information on follow-up care appointments for survivors of breast, 
prostate, colorectal, endometrial, or Hodgkin and non-Hodgkin lymphoma cancers. We are requesting a 
waiver of consent to screen clinical schedules of participating practices and review medical records to 
identify potentially eligible participants to contact about participating in the study. This process presents no 
more than minimal risks of harm to the subjects.  

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Local NCORP site staff are encouraged to contact potentially eligible survivors prior to their appointment 
via mail, telephone, e-mail, patient portals, or other channels to provide study information, screen, and 
ascertain interest in participating. Screening can also take place in the clinic on the day of the appointment. 
A sample Survivor Recruitment Phone Script, Letter and Flyer are provided. An Informational Flyer 
entitled Cardiovascular Health Study for Cancer Survivors, should be provided to all patients, regardless of 
study participation, seeing an AH-HA trained provider in settings where the best practice alert might be 
activated and used during the visit, regardless of whether or not they have been recruited for the study. The 
purpose of this flyer is to inform patients at practices randomized to the AH-HA intervention that the practice 
is participating in a trial. 
 
The site coordinator will invite eligible survivors to participate in the research study, administer informed 
consent, and conduct the Pre-visit Baseline Survivor Survey (~15-20 minutes) before the visit with the 
provider. We will track numbers of individuals approached and screened and reasons for nonparticipation. 
Participants will be allowed to withdraw from the study at any time. A Survivor Recruitment & Intervention 
Scheme can be found in Figure 3. Finally, Table 1 below reflects the anticipated number of survivor 
participants enrolled at baseline. 
 
 
Table 1. Planned Enrollment Report for Patients 
 
Racial Categories 
Not Hispanic 
or Latino: 
 
Female 
Not Hispanic 
or Latino: 
 
Male 
Hispanic 
or Latino: 
 
Female 
Hispanic 
or Latino: 
 
Male 
 
Total 
American Indian/Alaska Native 
2 
1 
0 
0 
3 
Asian 
12 
1 
0 
0 
13 
Native Hawaiian or Other 
Pacific Islander 
1 
1 
0 
0 
2 
Black or African American 
49 
21 
0 
0 
70 
White  
360 
218 
21 
7 
606 
More Than One Race 
2 
4 
0 
0 
6 
Total 
426 
246 
21 
7 
700 
    Accrual Rate:  ___8__ pts/month   
 
Total Expected Accrual: __560___ Min __700_Max     
 
 

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Figure 3. Survivor Recruitment & Intervention Schema 
 
 
 

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4.6 
Patients:  Inclusion of Racial/Ethnic Minorities  
 
 
We will encourage participating practices to approach all potentially eligible survivors, regardless of gender 
or race/ethnicity. All survivor surveys will be available in English and Spanish. All Minority-Underserved 
NCORPs affiliated with the Wake Forest NCORP Research Base (WF NCORP RB) will be informed of the 
study and will be invited to participate. We will emphasize the importance of robust minority accrual at our 
study kickoff meetings and provide specific education and discussion about strategies to overcome barriers 
that underserved patients may experience to study participation. Leaders of the Wake Forest Baptist 
Comprehensive Cancer Center Office of Cancer Health Equity will facilitate this aspect of training and have 
provided feedback on our recruitment strategy. We will also ask participating Minority-Underserved 
NCORPs to provide suggestions about strategies for approaching and consenting racial/ethnic minority 
patients. We will monitor minority recruitment rates at our monthly WF NCORP RB committee meetings 
and provide feedback to the NCORP sites via bi-monthly study teleconference calls. Specifically, we will 
monitor the minority recruitment rate in conjunction with available data about the population of survivors to 
identify sites that are potentially under and over performing with regards to minority accrual. Sites with 
strong minority recruitment will be asked to share their experiences with other sites during these calls.   
 
4.7  
Key Informant Inclusion Criteria (Intervention Practice Sites Only) 
 
4.7.1 
Age ≥18 years 
 
4.7.2  Health care provider who completed the AH-HA provider training (e.g., physicians, nurse 
practitioners, physician assistants) AND 
 
Two members of the site administrative team who participated in the implementation of the AH-
HA tool. This will include clinic administrators and/or information technology specialists and 
is likely to include: facility program directors and other staff (e.g., technology support). 
Coordinators of centralized services for EHR maintenance at the practice would also be eligible. 
 
4.7.3 
Agrees to participate in a confidential 1-on-1 semi-structured interview with the research team. 
 
4.7.4 
Agrees to have the interview taped, transcribed and qualitatively analyzed.  
 
4.8 
Key Informant Recruitment and Retention Strategy (Intervention Practice Sites Only) 
 
The provider key informant assessment consists of two parts: 1) brief structured surveys at training and after 
30 patients are enrolled at the practice and 2) semi-structured interviews for a subset after 30 patients are 
enrolled at the practice. For more details on the key informant assessments, see Section 6.5: Key Informant 
Schedule of Events. All providers who complete the AH-HA training webinar (see Provider Training 
Outline) will have their attendance tracked and recorded. They will be approached for enrollment as key 
informants via a Provider Key Informant Recruitment Email sent by the WF NCORP RB. Provider key 
informants will be enrolled by the site provide their consent in REDCap by proceeding to the post-training 
survey questions. We anticipate that up to 30 providers may complete the structured surveys.  
 
Provider semi-structured interviews will be conducted by telephone after 30 patients are enrolled at a 
participating intervention practice. All providers will be identified via the process described above. If more 
providers completed training and meet these criteria, we will randomly select providers to complete the 
semi-structured interview. These provider key informants who have not already consented via the process 
describe above will be sent a Provider Key Informant Recruitment Email by the Wake Forest NCORP RB. 
 

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The administrator/IT specialist key informant assessment consists of one semi-structured interview 
conducted by telephone approximately 4 weeks after the tool is implemented in the clinic. NCORP site 
personnel will work with the Wake Forest NCORP research team to identify two administrator/IT specialist 
key informants within each intervention practice who participated in the AH-HA implementation process. 
These key informants will be enrolled by the site provide their consent in REDCap by proceeding to the 
Eligibility, Demographic, & Background questions.  
 
We anticipate conducting up to 42 key informant semi-structured interviews. The distribution of key 
informants includes: up to 20 AH-HA trained providers who used the tool with at least two patients (enrolled 
or not enrolled), up to 10 AH-HA trained providers who used the tool with less than two patients (enrolled 
or not enrolled), and 12 administrators/IT specialists. See Figure 4 for the distribution of key informants. 
 
Figure 4: Distribution of Key Informants 
 
 
 
Key informants will likely be in regular contact with members of the study team as part of the intervention, 
encouraging their retention. 
 
 
 
4.9 
Key Informants: Inclusion of Women and Minorities 
 
All nominated key informants, regardless of gender or race/ethnicity will be invited to participate.  
Of 42 total key informants, we expect 50% to be women, and 17% to be racial minority. Table 2 below 
reflects the anticipated number of key informants enrolled at baseline. 
 
 
 

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Table 2. Planned Enrollment Report for Key Informants 
 
 
Racial Categories 
Not Hispanic 
or Latino: 
 
Female 
Not Hispanic 
or Latino: 
 
Male 
Hispanic 
or Latino: 
 
Female 
Hispanic 
or Latino: 
 
Male 
 
Total 
American Indian/Alaska Native 
0 
0 
0 
0 
0 
Asian 
4 
3 
0 
0 
7 
Native Hawaiian or Other Pacific 
Islander 
0 
0 
0 
0 
0 
Black or African American 
1 
1 
0 
0 
2 
White  
16 
15 
1 
1 
33 
More Than One Race 
0 
0 
0 
0 
0 
Total 
21 
19 
1 
1 
42 
   Accrual Rate:  _2___ non-patients /month   
 
Total Expected Accrual: _38___ Min _42_Max     
 
 
5. 
STUDY INTERVENTION 
 
A barrier to efficiently accessing comprehensive and relevant data at the point-of-care is the diffuse 
presentation of CVH data in the EHR. Vital signs, laboratory results, prescription medications, and health 
behaviors are captured in multiple discrete fields on distinct screens in the EHR, and are frequently displayed 
within different activities. We designed the AH-HA tool to aggregate and display data relevant to CVH 
together, making it easily interpretable for patients and providers alike. 
 
Our AH-HA tool has been tested for ease of use in busy clinics and facilitates discussions to address CV risk 
issues. It is also more comprehensive and less obtrusive than previous tools. Our study will evaluate “real-
world” implementation of healthcare technology in a standards-compliant EHR environment. We 
successfully launched the original CVH tool in a primary care clinic, within Epic©, one of the most 
commonly used EHR systems in the United States. The tool has been built to connect with a variety of EHR 
platforms. We designed the AH-HA tool with a multidisciplinary team to integrate seamlessly into provider 
workflow, unlike other EHR-based clinical decision support systems. 
 
The AH-HA tool will not replace primary care management of CVH risk factors, intensive behavioral 
interventions to address weight loss or tobacco use, or specialty management of survivors at high risk for 
cardiotoxicity, nor does it require oncologists to change their practice to treat CV risk factors. Instead, it will 
facilitate CVH awareness and action by cancer survivors and their oncology providers. Through systematic 
assessment of the survivors’ CVH needs and triggering referrals, AH-HA will promote care coordination, 
but more explicit supplemental strategies such as structured information exchange between providers and 
agreements about managing CVH will likely be needed to optimize CVH care for survivors in community 
settings. 
 
AH-HA has three features, which leverage existing Epic functionality: (1) on-demand availability via a 
nondisruptive clinical decision support (CDS) alert; (2) automatic data retrieval for calculations and 
visualizations; and (3) a nonintrusive view, rendered on a lateral panel that allows concurrent EHR 
navigation (Figure 5). When the CDS alert is clicked, it triggers existing EHR application programming 
interfaces (APIs) that collect current encounter parameters for the patient from the vendor's live database, 

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and delivers them to the AH-HA tool via a secure POST http request. The AH-HA tool then retrieves 
historical data from the EHR database, and renders the resulting risk-profiling and visualization on an 
embedded instance of a Web browser engine. 
 
 
Figure 5. AH-HA tool shown as a lateral panel within the EHR 
 
 
 
AH-HA Tool Implementation. A list of topics to be covered in an AH-HA Tool Webinar for interested and 
enrolled practices is found in the AH-HA Tool Information document. The AH-HA tool can be programmed 
to launch for specified users during an encounter with eligible survivors, regardless of study participation; 
each practice will customize this to fit the needs of their enrolling providers. Extensive training and technical 
assistance will be provided by the Wake Forest NCORP Study team to ensure successful EHR tool 
implementation. We will make available an Epic© trained consultant for integration of the tool into the clinic 
and troubleshooting as necessary. We will also provide tablet technology and support to the clinics to 
facilitate data entry for survivors and NCORP staff. The study grant can reimburse up to $6,500 for IT 
services needed for AH-HA implementation, if requested. 
 
 
Required AH-HA Training for Providers. Practices must identify at least two providers (physicians, nurse 
practitioners, or physician assistants) who routinely provide post-treatment follow-up care to eligible patients 
and agree to be trained and use the AH-HA tool. All training will be provided via webinars and 
teleconferences (see Provider Training Outline for a list of training topics). Two 30-min AH-HA tool 
tutorials for all oncology providers who intend to enroll survivors from the 6 intervention clinics will be 
recorded as webinars and viewed online at a time of the provider’s choosing in the month before 
implementation of the AH-HA tool in the clinic. The provider training will include an Epic AH-HA Dot 
Phrase template that providers can use to summarize their cardiovascular health discussion with the patient. 
It is intended as a guideline and its usage is not required by the study. Completion of the provider training 
will be tracked centrally by the WF NCORP RB via the Provider Training Attestation form that providers 
email after training completion. The educational sessions will review primary prevention of CV disease risk 
factors according to AHA guidelines for healthcare professionals, cardiotoxicity of cancer treatments, and 
case-based examples illustrating use of the AH-HA tool in CVH discussions during survivorship care.  
 
 

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6. 
STUDY EVALUATIONS AND PROCEDURES 
 
6.1 
Survivor Schedule of Events 
 
Evaluation of the intervention depends on administration of surveys at baseline pre- and post-visit, 6 month 
and 1 year after baseline. The Survivor Consent Script and all surveys will be available in English and 
Spanish. Sites will mail the consent script to participants who request a copy of the consent information.  
 
SURVIVOR SCHEDULE OF EVENTS 
 
*  available in English and Spanish 
§  preferably completed in-person immediately following visit, but may be completed by telephone 
within 48 hours of baseline visit 
£  in-person or by telephone 
 
†  intervention sites only 
¥  these 3 surveys should be completed before the visit and are listed in order of priority. If they 
are not completed before the visit begins, they should be left incomplete and not completed 
after the visit. 
€  the Medical Record Release and Demographic & Health Behaviors can be completed before 
or after the visit.  
Evaluation 
Screening 
Baseline 
Pre-Visit 
Baseline 
Post-Visit 
6 Month 
Visit 
 
(±30 days) 
1 Year 
Visit 
 
(-30 to + 
60 days) 
Eligibility 
X 
Enrollment in CTSU-OPEN 
 
X 
 
 
 
Reason for Refusal  
(if applicable) 
X 
 
 
 
 
Informed Consent * 
X  
Health Assessment * 
X ¥ 
X § 
 X £ 
X £  
Health Visit Information *  
X ¥ 
 X £ 
X £ 
Health Knowledge  
Assessment * 
 
X ¥ 
 X § 
 
 
Medical Record Release 
(provided by local site) 
 
X € 
 
 
 
Demographic & Health 
Behaviors * 
 
X € 
 
 
 
Counseling & Referral 
Assessment *  
 
 
X § 
 
 
Tool Assessment *† 
X § 
Medical Record Data  
 
 
X 
 
X 

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6.2  
Prior to Enrollment 
 
Local NCORP site staff will screen individuals for eligibility prior to or during a regularly scheduled 
appointment. If the individual meets all eligibility criteria and agrees to participate, trained NCORP site staff 
at each NCORP practice site will seek interest and consent the patient. The study has requested a waiver of 
documentation of consent, so site staff will use the Survivor Consent Script to document the participant’s 
consent decision. This script will be used whether the participant is consented remotely or in-person (see 
Appendix A for virtual visit considerations). Consent may be obtained up to two weeks prior to the 
designated AH-HA appointment. Sites should enroll the participant into CTSU OPEN after the participant 
is consented. Participants must also sign a medical record release form provided by the local affiliate/sub-
affiliate to allow the request of records from providers outside the study site facility. 
 
Participants will be excluded if they do not meet the inclusion/exclusion criteria. Individuals who decline 
participation will be asked to complete the Reason for Refusal Form which includes basic demographic 
information and primary reason for declining study participation. This form will be entered into the REDCap 
screening project by NCORP site staff. 
 
6.3  
Baseline Assessment 
 
The Pre-visit Baseline Survivor Survey must be completed within two weeks prior to the designated AH-
HA routine follow-up care appointment. If the participant is completing this survey by phone or virtually 
because they are scheduled for a virtual AH-HA appointment, the survey should be given to the participant 
on the same day that the participant is consented and enrolled. If the participant is scheduled for an in-person 
AH-HA appointment, they should complete this survey in the clinic just prior to the appointment. The Health 
Assessment, Health Visit Information, and Health Knowledge Assessment components should be given in 
that order during the Pre-visit Baseline Survey. If they are not completed before the visit begins, they should 
be left incomplete and not returned to after the visit. The Medical Record Release and Demographic & 
Health Behaviors can be completed before or after the visit. 
 
For intervention sites only, the local NCORP site coordinator or the participant will fill out the diet and 
exercise status answers via a paper form (Diet and Exercise Status) and give it to the provider at the 
beginning of the visit so that the provider can put that information into the AH-HA tool. An AH-HA Patient 
Notification sign will be available to sites to alert the provider that the AH-HA tool should be used in this 
visit for enrolled participants (see Appendix A for virtual visit considerations), but the provider can use the 
AH-HA tool at his/her discretion with any eligible patient from their clinic. Usual care sites will not alert the 
provider that the patient is an AH-HA study participant because they will not be using the AH-HA tool.  
 
For intervention and usual care sites, the Post-visit Baseline Survivor Survey must be completed no more 
than 48 hours after the designated AH-HA appointment (a maximum of five days from the designated AH-
HA appointment is allowed if the participant cannot be reached by the study staff within the first 48 hours). 
More information on the assessments included in these Baseline Survivor Surveys can be found in Section 
6.1. Core measures include: demographics, health status, perceptions of CV risk, and receipt of CVH 
discussions and referrals. The baseline assessments will be completed in-person (see Appendix A for virtual 
visit considerations), in conjunction with a regularly scheduled follow-up care visit with a participating 
provider. In the rare case that an appointment is cancelled after a Pre-visit Baseline Survivor Survey is 
completed, this survey does not need to be repeated if the appointment is rescheduled within 7 days. The 
Post-visit Baseline Survivor Survey should be completed immediately after the designated AH-HA 
appointment. In the rare case that a patient does not complete the Post-visit Baseline Survey on the same 
day, this survey should be completed in-person or by phone within 48 hours of the designated AH-HA 

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appointment. All responses will be recorded on paper forms and/or entered directly into the online database. 
Local NCORP site staff will be responsible for entering the data into REDCap. Local NCORP site staff will 
also complete the Medical Record Data form at the post-visit time point. 
 
Participants will receive a $10 gift card when the Post-visit Baseline Survivor Survey is completed. 
Electronic gift cards will be sent directly to the patient if the patient provides an email. The Wake Forest 
NCORP project management team will maintain a log of distributed gift cards. If the patient does not have 
an email, the electronic card will be sent to the local NCORP site coordinator who will print the card and 
either mail or give it to the patient in person. 
 
6.4 
 6 Month and One Year Assessments 
Local NCORP site staff will contact each participant to complete a 20-minute survey (in-person or by 
telephone) six months (±30 days) and one year (-30 to + 60 days) following the baseline clinic visit. This 
assessment focuses on completed healthcare visits and CVH behaviors and can be found in the 6 Month 
Visit Survivor Survey and 1 Year Visit Survivor Survey, respectively. More information on the assessments 
included in these Survivor Surveys can be found in Section 6.1. Participants will be offered a $5 electronic 
gift card for completing each survey. Local NCORP site staff will also complete the Medical Record Data 
form at the 1 year time point. 
To minimize attrition, local NCORP site staff will mail letters (Survivor 6 Month & 1 Year Reminder Letter) 
to participants 1-2 weeks prior to the six month and one-year follow-up surveys. At least five attempts will 
be made to reach each participant by phone. As a final step, the team will consider a mailed survey to non-
respondents that includes a gift card. 
 
6.5   Key Informant Schedule of Events (Intervention sites only) 
 
Evaluation 
Administrator/ 
IT Specialist  
Providers who 
use AH-HA 
Trained, but 
non-using 
Providers 
Enrollment in CTSU-OPEN  
X 
X 
X 
 Informed Consent 
X 
X 
X 
Eligibility, Demographic & Background  
X§ 
X# 
X# 
Post-Training Provider Structured 
Survey 
 
X 
X 
Post-Enrollment Provider Structured 
Survey # 
 
X 
X 
Administrator/IT Specialist Semi-
Structured Interview §   
X* 
 
 
Provider Semi-Structured Interview #    
 
X* 
X* 
Unified Theory of Acceptance and Use of 
Technology (UTAUT) Survey € 
 
X 
 
#   after 30 patients are enrolled in study 
§   approximately 4 weeks after implementation 

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*  Completed by the Wake Forest NCORP and WFBCCC Q-PRO Shared Resource Teams; up to 20 
providers who used AH-HA and 10 providers who were trained but did not use AH-HA will 
complete an interview.   
€   The UTAUT is part of the provider post-enrollment structured survey, but will only be given to 
providers who used the tool. 
 
 
The key informant assessment for providers consists of: 1) A Post-Training Provider Structured Survey 
immediately after training, 2) a Post-Enrollment Provider Structured Survey and 3) a Provider Semi-
Structured Interview after 30 patients are enrolled at the practice. The key informant assessment for 
administrators/IT specialists consists of an Administrator/IT Specialist Semi-Structured Interview 
approximately 4 weeks after the tool is implemented in the clinic. Research staff with expertise in qualitative 
data collection from the Wake Forest team and the Wake Forest Baptist Comprehensive Cancer Center 
Qualitative and Patient-Reported Outcomes (Q-PRO) Shared Resource will conduct one-on-one interviews 
by telephone with providers and administrators. Interviews will be scheduled by the Wake Forest and Q-
PRO teams with assistance from practice site NCORP team members. All providers and key administrators 
will also be asked to provide basic demographic (age, sex, and race/ethnicity) and practice (years in practice, 
position title, and discipline) information on the Eligibility, Demographic & Background Information via 
a REDCap survey link emailed to them. 
 
The Post-Training Provider Survey will assess the initial reactions of the providers to the AH-HA tool. 
Providers will receive a $10 gift card after this survey. They will have the option to decline compensation. 
The Provider Post-Enrollment Structured Survey focuses on the feasibility and sustainability of the 
clinical decision support tool.  The performance, effort, attitude, facilitating conditions, and behavioral 
scales of the Unified Theory of Acceptance and Use of Technology (UTAUT) Survey will be 
administered to all AH-HA trained providers who use the tool with patients as part of the Provider Post-
Enrollment Structured Survey to assess factors associated with tool use. The surveys are estimated to take 
5 minutes at training completion and post-enrollment.  
 
Administrator/Provider Semi-Structured Interviews will focus on: (a) adoption; (b) implementation; and 
(c) maintenance of electronic health record-based clinical decision support. Interview topics were guided by 
the “RE-AIM Checklist for Study or Intervention Planning”, “RE-AIM Model Dimension Items Checklist” 
and the Consolidated Framework for Implementation Research (http://www.cfirguide.org/) and include:104-
106 (1) general perceptions and perceived impact of AH-HA tool on practice, providers, and patients, (2) 
barriers and facilitators to implementing AH-HA in the practice (emphasizing implementation constructs 
such as Perceived Effectiveness, Intervention Characteristics, Adaption, Maintenance, Implementation, 
Outer Setting, Inner Setting, and Adoption), and  (3) suggested changes to AH-HA  to improve future 
adoption, implementation, and maintenance. Administrator interviews will be conducted approximately 4 
weeks after the AH-HA tool has been fully implemented at the intervention practice. Provider interviews 
will take place after 30 enrollments at the practice. 
 
Administrator/Provider Semi-Structured Interviews will last approximately 30 minutes and be audiotaped; 
participants will receive a $20 electronic gift card. They will have the option to decline compensation at the 
end of the interview. Digital recordings of each interview will be independently transcribed verbatim to 
ensure validity. We will also ask administrators to estimate the time and cost (personnel and other) of AH-
HA tool implementation, to include: provider training and AH-HA tool integration into their site. 
 
 
 

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7.  
CRITERIA FOR EVALUATION AND ENDPOINT DEFINITION 
 
7.1    Summary Table of Endpoints, Measures, Measurement Strategies, and Time Points 
 
  
Measure 
Measurement Strategy 
Time Point(s) 
Primary Endpoint 
(Effectiveness, Aim 1) 
CVH discussions (at least 
one non-ideal CVH factor 
discussed) 
Survivor survey 
(discussions, diet, and 
primary care); EHR for 
other CVH factors 
Baseline: 
 post-visit 
Secondary Endpoints  
(Effectiveness, Aim 1)   
1) Referrals to primary care 
and cardiology and 2) 
efforts to manage CV risk 
(ordering of CVH-relevant 
labs and treatments) 
Medical chart 
abstraction 
1 year 
Secondary Endpoints 
(Effectiveness, Aim 2) 
1) Number and date of 
primary care and 
cardiology visits in the past 
year, 2) CVH behaviors 
(smoking status, BMI, 
physical activity, and 
healthy diet) and CVH 
factors (total cholesterol, 
blood pressure, and fasting 
plasma glucose/A1c), 3) 
perception of CV risk, 
knowledge of CVH factors, 
and patient activation, 4) 
Satisfaction with care 
1 & 2) Medical chart 
abstraction (survivor 
survey as secondary 
verification source/ 
primary for diet and 
physical activity) 
 
 
3 & 4) Survivor survey 
Baseline; 1 year 
  
 
 
 
 
Baseline: pre & 
post-visit; 6 mo, 
& 1 year 
Secondary Endpoints 
(Implementation, Aim 3a) 
Proportion and 
characteristics of survivors 
for whom AH-HA is 
utilized in clinic, regardless 
of enrollment to the study 
EHR log data from 
Clarity Query 
  
  
1 year 
  
  
Secondary Endpoints 
(Implementation Aim 3b) 
  
Barriers and facilitators to 
the adoption, 
implementation, and 
maintenance of the tool in 
intervention practices 
 
Tool acceptability 
Key informant 
interview- including 
structured survey and 
semi-structured 
interviews 
 Implementation Time 
Study Template 
 
Survivor Surveys 
After 30 patients 
are enrolled 
(provider) and 4 
weeks after 
implementation 
(admin/IT) 
 
Baseline: 
post-visit 
 

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7.2 
Primary Endpoint 
 
Immediately after their survivorship care appointment, at baseline, each survivor will be asked if they were 
counseled on 10 topics: 7 CVH topics (BMI, physical activity, diet, smoking status, blood pressure, 
cholesterol, and glucose), and 3 distractor topics (flu vaccination, shingles vaccination, and fall prevention). 
Questions were adapted from the NCI APECC107 and FOCUS25 studies (Survivor Surveys). All questions 
are consistent with prevention services covered by the Affordable Care Act (blood pressure, cholesterol, and 
diabetes screening; diet counseling; obesity screening and counseling; and tobacco screening and cessation 
support), and thus have important implications for meaningful use of EHRs.108 The primary outcome will be 
the proportion of patients reporting at least one non-ideal or missing CVH topic discussed during the visit.  
 
7.3 
Secondary Endpoints 
 
We will also ask survivors about (1) having a primary care provider and cardiologist, (2) the number of 
visits, and (3) date of last visit to primary care providers and cardiologists in the past year, query the EHR 
for documentation, and obtain consent to obtain medical records to ascertain out-of-network visits. These 
data will additionally be used as a stratification variable in exploratory analyses for Aims 1 & 2.  
 
Additional Outcomes of Interest (Aim 1). In addition to the primary endpoint of any discussion of a non-ideal 
or missing CVH topic, we will summarize the proportion of survivor reported discussions with their provider 
for each of the 7 non-ideal or missing CVH topics. Additionally, we will summarize for each survivor the 
proportion of non-ideal topics discussed. We also will review clinic notes from intervention and control 
clinics to document preventative discussions regarding CVH at each survivor visit that occurs between 
baseline and follow-up.128 At baseline and follow-up, survivors will be asked if they received referrals to see 
a primary care provider and/or a cardiologist (Survivor Surveys). We also will review clinic notes to 
document referrals and communication with other providers regarding CVH at each survivor visit that occurs 
between baseline and follow-up. We will also document orders for CVH-relevant labs and treatments.128 
Provider orders for total cholesterol and glucose/hemoglobin A1c will be queried according to the 
methodology of our study of the previous CVH tool.27,28 Relevant CVH medication data will be abstracted 
according to previously described methodology, and will include orders for: blood pressure, cholesterol, and 
diabetes (insulin and pill) medications.27,28 These laboratory and medication data are input in the “order” 
screen of the EHR and will be collected for each survivor-provider encounter. 
 
Additional Outcomes of Interest (Aim 2). The 4 CVH behaviors (smoking status, BMI, physical activity, and 
healthy diet) and 3 CVH factors (total cholesterol, blood pressure, and fasting plasma glucose/A1c) will be 
collected during usual clinical care, or queried via tablet prior to the survivor’s appointment.84 As physical 
activity and diet data are not typically stored in the EHR, survivors will be asked to enter these data onto a 
paper form or into a tablet upon arrival for their scheduled appointment (Survivor Surveys). CVH is an 
evidence-based metric, called “Life’s Simple 7”, which was developed and validated by the AHA in 2010108 
and has been used in more than 100 publications to date. We will categorize each CVH component according 
to clinical cut-points established by the AHA.108 At baseline and follow-up, we will also ask survivors about 
their perception of their CV risk and their knowledge of their CVH factors (Survivor Surveys). Health 
knowledge questions were adapted from a survey assessing the relative risk of cancer and cardiovascular 
disease in United States populations.117 
 
Additional Outcomes of Interest (Aim 3). Quantitative EHR data from system use logs will be used to 
determine the frequency and duration of use of the AH-HA tool in intervention clinics for Aim 3.102 We will 
also capture the number of eligible patient visits, regardless if they were enrolled on the study or not, during 
which the AH-HA tool was used in intervention clinics and the total number of eligible visits. We will 
receive these EHR data from intervention sites via a Clarity Query that includes the data fields outlined 

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below. Sites will send us a query monthly for audit purposes to ensure functionality of the tool and at the 
end of year 1 for research purposes (Implementation, Aim 3a). Sites will securely upload the query as a CSV 
file to an NCORP REDCap project. The primary outcome for these analyses is the ratio of eligible patient 
visits during which the AH-HA tool was used / total number of eligible visits. The following data will be 
extracted from the EHR for both enrolled and unenrolled eligible patients: patient (age, sex, race/ethnicity, 
health insurance type, comorbidities),  cancer characteristics (stage and type), cardiovascular health (blood 
pressure, blood pressure medication, hemoglobin A1C, diabetes medication, total cholesterol, cholesterol 
medication, BMI, smoking), visit (visit type, reason for visit, time since first visit with a provider in the 
study, inpatient or outpatient encounter) and AH-HA tool usage (enrolled, mode, alert month, action taken, 
BPA location, BPA identifier)  All patient information will be de-identified before submission to WF 
NCORP RB, but sites should ensure they are compliant with all local HIPAA policies when gathering the 
data. Provider data (sex, years in practice, specialty) will be obtained by linking the National Provider 
Identifier (NPI) from the EHR to the NPI registry (https://npiregistry.cms.hhs.gov/), which discloses these 
and other provider-level data to the public as part of the Freedom of Information Act.109 Sites will also 
complete the AH-HA Tool Implementation Time Study Template to provide information about the person-
hours required for each IT implementation step to determine cost and capacity. This will be completed with 
the key informant interview 4 weeks after implementation. In the Baseline: Post-Visit Survey, survivors will 
complete a Tool Assessment questionnaire assessing whether or not they recall seeing or discussing the AH-
HA tool with their provider and five questions assessing: how much they liked the tool, how helpful it was, 
how easy it was to understand, how much it improved their understanding, and if they would like to use this 
tool in the future.   
 
7.4 
Off-Study Criteria 
 
Participants may go ‘off-study’ for the following reasons: the protocol intervention and any protocol-
required follow-up period is completed, AE/SAE, lost to follow-up, withdraw consent, death, determination 
of ineligibility. 
 
7.5 
Study Termination 
 
NCI, DCP as the study sponsor has the right to discontinue the study at any time.  
 
 
8. 
REPORTING ADVERSE EVENTS  
 
This is a group randomized controlled trial with minimal risks. No routine Adverse Events or Serious 
Adverse Events are reported. 
 
 
9. 
STUDY MONITORING 
 
9.1 
Data Management 
 
Data management for this study will be done electronically using the following systems. 
 
Participant Enrollment 
REDCap/OPEN 
Surveys and Data Collection 
REDCap 
 
REDCap is a secure, web-based, and easy to program forms and research database platform utilized by the 

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WF NCORP for many research projects. This study will be using REDCap as the electronic data collection 
platform including electronic Case Report Form (eCRF) for multi-site studies.  
 
 
9.2 
Case Report Forms 
 
Protocol-specific case report forms (CRFs) will be submitted electronically to the WF NCORP Research 
Base Data Management Center via OPEN and/or REDCap within 14 days of visit, phone call or time point 
completion.  Refer to the Schedule of Events in Section 6.1 and 6.5, showing the specific forms that are 
needed for each study visit.  
Do not submit study data or forms to CTSU Data Operations.  
Do not copy the CTSU on data submissions. 
 
9.3 
Source Documents 
 
Source documents are the original signed and dated records of participant information (e.g., the medical 
record, shadow chart) which may include electronic documents containing all the information related to a 
participant’s protocol participation. Source documents are used to verify the integrity of the study data, to 
verify participant eligibility, and to verify that mandatory protocol procedures were followed. An 
investigator and other designated staff are required to prepare and maintain adequate and accurate 
documentation that records all observations and other data pertinent to the investigation for each individual 
participating in the study. All data recorded in the research record (including data recorded on CRFs) must 
originate in the participant’s medical record, study record, or other official document sources. 
 
Source documents substantiate CRF information. All participant case records (e.g., flow sheets, clinical 
records, physician notes, correspondence) must adhere to the following standards: 
• 
Clearly labeled in accordance with HIPAA practices so that they can be associated with a 
particular participant or PID; 
• 
Legibly written in ink; 
• 
Signed and dated in a real time basis by health care practitioner evaluating or treating the 
participant; and 
• 
Correction liquid or tape must not be used in source documents or on CRFs. 
 
All laboratory reports, pathology reports, x-rays, imaging study and scans must have: 
• 
Complete identifying information (name and address of the organization performing, analyzing, 
and/or reporting the results of the test); and 
• 
Range of normal values for each result listed. 
 
9.4 
Data and Safety Monitoring Plan 
 
In accordance with the NIH requirement, a Data Safety and Monitoring Plan (DSMP) has been established 
to guide the oversight of this study in order to ensure the safety of participants and the validity and integrity 
of the data. This monitoring will be commensurate with minimal risk present to participants. 
 
The Wake Forest NCORP Research Base Data and Safety Monitoring Committee (DSMC) meets monthly 
to review reportable Adverse Events and Protocol Deviations to identify urgent safety and data concerns that 

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may affect study safety and data quality. Adverse Event and Protocol Deviation reports are generated by the 
Wake Forest NCORP Research Base Data Management team. The DSMC consists of members of the Wake 
Forest NCORP Research Base team including one of the NCORP Research Base Multi-PIs, the Wake Forest 
NCORP Research Base Administrator, regulatory, and data team members.  
 
The Wake Forest NCORP Research Base Data and Safety Monitoring Board meets every six months to 
review Wake Forest NCORP Research Base protocols.  The Board includes members demonstrating 
experience and expertise in oncology, biological sciences, biostatistics and ethics. The DSMB report is 
generated by the Research Base statistician. Areas of review may include the following: Study Objectives; 
Patient Accrual; Patient Status and Retention; Study Status; Last Contact Status; Patient Compliance; 
Number of Biopsies/Labs as needed; Patient Characteristics; Summary of Observed Toxicities; Adverse 
Events; Date, Event briefly described, Relationship to Drug, Arm assigned; Summary of Primary and 
Secondary Measures. 
 
DSMB Responsibilities: The DSMB reviews accrual information and interim analyses of outcome data and 
cumulative toxicity data summaries to determine whether: 
 
• 
the trial should continue as originally designed 
• 
the trial should be changed 
• 
the trial should be terminated 
• 
outcome results should be released prior to the reporting of the study results 
 
Members of this committee as well as the organization statistician will oversee the safety monitoring of the 
study to ensure that the privacy of all participants in the study is protected; ensure that participants' interests 
are primary, that is, above the interests of the scientific investigation; and to ensure that all data collection is 
scrutinized for accuracy, privacy and levels of protection. The committee will perform reviews of the data 
handling and confidentiality and comply with recommendations to resolve such problems, and maintain 
written communication of the deliberations and recommendations that arise from their meetings. By 
examining this information, they will keep abreast of critical issues regarding recruitment and data integrity. 
Reports of all DSMB meetings and recommendations will be provided to the NCI, CIRB, WF NCORP RB, 
and participating sites, as requested. 
 
9.5 
 Protocol Adherence 
 
Investigators ascertain they will apply due diligence to avoid protocol deviations. If the investigator feels a 
protocol deviation would improve the conduct of the study this must be considered a protocol amendment, 
and unless such an amendment is agreed upon by the Study PI and approved by the DCP, CIRB and any 
other stakeholders, it cannot be implemented. All protocol deviations will be recorded on the Protocol 
Deviation Log in REDCap. 
 
9.6 
Sponsor or FDA Monitoring 
 
The NCI, DCP (or their designee) or Wake Forest NCORP Research Base may monitor/audit various aspects 
of the study. These monitors will be given access to facilities, databases, supplies and records to review and 
verify data pertinent to the study. This protocol does not include pharmaceuticals or require FDA monitoring. 
 
 
 
 

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9.7 
Record Retention 
 
CLINICAL RECORDS FOR ALL PARTICIPANTS, INCLUDING CRFS, ALL SOURCE 
DOCUMENTATION (CONTAINING EVIDENCE TO STUDY ELIGIBILITY, HISTORY AND 
PHYSICAL FINDINGS, LABORATORY DATA, RESULTS OF CONSULTATIONS, ETC.), AS 
WELL AS IRB RECORDS AND OTHER REGULATORY DOCUMENTATION WILL BE 
RETAINED BY THE INVESTIGATOR IN A SECURE STORAGE FACILITY IN COMPLIANCE 
WITH HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA), 
OFFICE OF HUMAN RESEARCH PROTECTIONS (OHRP) AND NCI/DCP REQUIREMENTS, 
UNLESS THE STANDARD AT THE SITE IS MORE STRINGENT. WAKE FOREST NCORP 
RESEARCH BASE REQUIRES THE RECORDS TO BE RETAINED FOR AT LEAST 5 YEARS 
AFTER THE STUDY IS DISCONTINUED AND THEY SHOULD BE NOTIFIED PRIOR TO ANY 
PLANNED DESTRUCTION OF MATERIAL, UNLESS THE STANDARD AT THE SITE IS 
MORE STRINGENT. NCI WILL BE NOTIFIED PRIOR TO THE PLANNED DESTRUCTION 
OF ANY MATERIALS.  
 
10. 
STATISTICAL CONSIDERATIONS 
 
10.1 
Study Design/Description 
 
A group-randomized study design will assess the effectiveness of the AH-HA tool on delivery of CVH 
discussions. and referrals to primary care and cardiology, as well as CVH monitoring and treatment. Six 
months after AH-HA implementation, qualitative data will be collected from NCORP oncology providers 
in intervention clinics who completed the AH-HA provider training and key clinic administrators.  
 
10.2 
Randomization/Stratification  
 
Randomization will be used to achieve balance on clinic-level characteristics to assess outcomes related to 
Aim 1 (provider behavior) and Aim 2 (survivor visits and CVH). The pre-randomization eligibility checklist 
will include organizational characteristics that may influence the adoption and adaptation of electronic health 
record-based clinical decision support. We will randomize the sites in groups of two to the intervention (n=4-
6) or usual care (n=4-6) arms. Our multi-faceted training program targets health care delivery system changes 
(e.g., providers, clinics); therefore, all patients seeking follow-up services at a single site will be in either the 
intervention or usual care arm of the RCT. If a practice opts out post-randomization, another practice will 
be selected from the remaining eligible clinics within the NCORP site or another NCORP site will be added. 
 
10.3 
Accrual and Feasibility 
 
With over 973 affiliates/sub-affiliates within the Wake Forest NCORP Research Base network, we do not 
anticipate having any challenges with accruing 8-12 affiliates/sub-affiliates to participate in this study. In 
2015 and 2017, we surveyed NCORP practice groups participating in cancer care delivery research (CCDR) 
and obtained response rates of 87% and 73%, respectively. In the 2017 survey, 94% of practice groups 
reported having an outpatient EHR. Epic© is the most common system, used by 47% of practice groups with 
an EHR. We anticipate screening approximately 1,500 participants from up to 12 clinics in order to enroll a 
minimum of 280 participants in the intervention and 280 participants in the usual care arms at baseline and 
expect to retain 80% of baseline participants to participate in the one year telephone survey.49,50  
 
 
 

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10.4 
Primary Objective, Endpoint, Analysis Plan 
 
10.4.1 
Analysis Plan 
 
Our primary outcome is the delivery of CVH discussions as assessed by patient self-report during the post-
appointment survey. This will be quantified as yes if any non-ideal or missing CVH topic or no if nothing 
was reported as discussed. Participants must complete both parts of the baseline visit (pre and post) to be 
included in the analysis; otherwise, they will be replaced. Additionally, although we do not anticipate 
many survivors to present with all ideal CVH factors, any survivor that has no topics needing discussion 
at time of visit will also be replaced.108  
 
A mixed effects logistic regression model will assess the effect of the intervention on delivery of CVH 
discussions between intervention and usual care clinics. Intervention group will be a fixed effect and the 
practice will be a random effect. We plan to conduct two specific subgroup analyses, examining the 
intervention effect stratifying by whether each participant received cardiotoxic treatment as part of their 
cancer treatment, and whether the participant visited a primary care provider in the year preceding the 
baseline visit. We will also summarize reported discussions for each of the 7 non-ideal topics as well as 
the proportion of non-ideal topics discussed for each survivor.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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10.4.2 
Statistical Power 
In a group-randomized trial (GRT), statistical power critically depends on the degree of similarity between 
individuals from the same group compared to individuals from other groups, commonly summarized via 
the intraclass correlation coefficient (ICC). Well-powered GRTs are often difficult to design as seemingly 
small differences in the ICC (moving from 0.01 
to 0.05) can have a dramatic effect on power, 
and because finding estimates of the ICC in the 
literature is often difficult.110, 111 We expect a 
low ICC according to those published in the 
literature,112 ranging from 0.02 (physical 
activity) to 0.03 (obesity).111, 113 In addition, 
Eldridge et al. summarize ICCs from GRTs and 
indicate a median ICC of 0.04 across 13 GRTs. 
 
In Table 3, we summarize the needed sample size per practice 
for the outcome of delivery of CVH discussions (yes vs no), 
assuming 6 practices per treatment group, 80% power, an 
alpha level of 0.05, 20% loss to follow-up, and ICCs ranging 
from 0.03 to 0.05. Assuming we accrue an average of 50 
survivors per practice (minimum sample of at least 600 
survivors), we will have at least 80% power provided the rate 
of CVH discussions under the usual care condition is ≤15%, 
and that exposure to the AH-HA tool raises the rate of CVH 
discussions to 35% or more. If the rate of CVH discussions is 
higher in the usual care group (i.e. 20%), then the rate of 
receipt of CVH discussions will need to be 40% or more in 
the AH-HA group to have >80% power.  
 
With a potential for fewer practices (i.e. 8-10) instead of the 
originally projected 12, increasing the average number of 
participants per practice to 70 will maintain adequate power for 
the same 20% difference (or more) shown in Table 3 scenarios. 
This still incorporates up to 20% loss to follow-up with ICCs 
ranging from 0.03 to 0.05 (Table 4). There are a few scenarios 
where we are slightly underpowered (shaded in grey in Table 
4), but feel this is a necessary tradeoff between number of 
practices and survivors enrolled at overly conservative ICC 
values. We acknowledge that the overall sample size of survivors may change depending on the final number 
of practices recruited for the trial, but we anticipate the number of survivors enrolled to be between 560-700 
Table 3. Average sample size across 12 practices to 
provide 80% power by ICC and CVH discussion rate.  
  
  
pAH-HA 
ICC 
pUC 
25% 
30% 35% 
40% 45% 
50% 
0.03 
10% 
38 
17 
10 
7 
5 
4 
15% 
NF 
58 
22 
12 
8 
6 
20% 
NF 
NF 
84 
26 
14 
9 
0.04 
10% 
55 
19 
11 
7 
5 
4 
15% 
NF 
109 
26 
13 
8 
6 
20% 
NF 
NF 
274 
33 
16 
9 
0.05 
10% 
99 
23 
12 
7 
5 
4 
15% 
NF 
1234 
33 
15 
9 
6 
20% 
NF 
NF 
NF 
45 
18 
10 
pAH-HA=rate of CVH discussion in intervention clinics 
pUC=rate of CVH discussion in usual care clinic 
NF=Not a feasible design; ICC= intraclass correlation 
coefficient 
Table 4. Power for various total practices with an
average of 70 participants by ICC and 20%
difference in CVH discussion rate.
Total
ICC
pUC
pAH-HA Practices
Power
8
91.9
10
96.4
12
98.4
8
87.0
10
93.2
12
96.6
8
82.8
10
90.2
12
94.5
8
86.3
10
92.7
12
96.3
8
80.2
0.04
10
88.1
12
93.1
8
75.4
10
84.1
12
90.0
8
80.6
10
88.4
12
93.3
8
73.7
0.05
10
82.7
12
88.8
8
68.6
10
78.0
12
85.0
20%
40%
0.03
20%
40%
10%
30%
15%
35%
20%
40%
10%
30%
15%
35%
10%
30%
15%
35%

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total. And practices may recruit variable numbers of survivors, as long as we average 50 per practice for 12 
total practices or average 70 per practice for 8-10 total practices, power will be maintained as shown in the 
tables above. 
 
The planned subgroup analyses (receipt of cardiotoxic cancer treatment and having a primary care visit in 
the past year) will be largely exploratory. We will be well-powered to detect scenarios where the 
intervention’s effect is isolated to a particular subgroup, for example, if the AH-HA tool increases CVH 
discussions only in individuals that had not seen a PCP in the past year, but is ineffective in individuals 
with such a visit. For example, based on simulation, conservatively assuming that 20% of participants will 
not have had a primary care visit in the past year (in OSU data, 79% of breast cancer survivors had a 
primary care provider documented in the EHR), power to detect such an interaction will be >80% provided 
the rate of CVH discussions is slightly more than doubled in those without a primary care provider. In 
subgroup analyses, we will additionally consider variation due to survivor characteristics such as sex and 
age. 
 
The outcome of at least one visit to primary care providers/cardiologists in the prior year shares the same 
data structure (binary outcome observed at a single point in time) as our primary outcome; the power 
calculations presented in the previous section also apply. We focus our calculations on the ability to detect 
a difference at one-year for BMI, which showed improvements in our primary care pilot data from OSU. 
We expect that we will not show appreciable changes in smoking status, diet, and physical activity levels 
with use of the AH-HA tool. Assuming an ICC of 0.04, 50 participants per clinic (12 clinics), and a 
standard deviation of 5.8 kg/m2, we will have >80% power to detect a 2.5 kg/m2 mean difference in BMI 
between the intervention and usual-care groups. 
 
10.5 
Secondary Objectives, Endpoints, Analysis Plans 
 
As outlined in section 7.3, we will also ask survivors about (1) having a primary care provider and 
cardiologist, (2) the number of visits, and (3) date of last visit to primary care providers and cardiologists in 
the past year, query the EHR for documentation, and obtain consent to obtain medical records to ascertain 
out-of-network visits. Secondary analyses will include survivor and provider covariates (e.g., survivor and 
provider age, survivor sex, cancer type), HRSA data (https://data.hrsa.gov/tools/shortage-area/hpsa-find) 
which will identify health professional shortage areas, and baseline CV risk to assess the effect of these 
factors on outcomes and to see if the intervention effect is more pronounced in certain subgroups. We will 
use a similar analytic framework (mixed effects logistic models) to assess the effect of the intervention on 
primary care and cardiology referrals/visits and the ordering of CVH-relevant laboratory tests or treatments 
during the one-year follow-up period. We hypothesize that the proportion of referrals will be higher in 
intervention compared to usual care clinics; we expect the proportion of referrals to increase from baseline 
to one-year in the intervention clinics but not usual care clinics (the effect of intervention fidelity: being 
exposed to the AH-HA tool). 
 
Similar in the approach for the primary objective, a mixed effects logistic regression model will assess the 
effect of the intervention on the likelihood of at least one visit to primary care in the past year at one-year 
follow-up, controlling for whether the participant visited a primary care provider in the year prior to study 
baseline. We expect that the proportion of completed primary care visits will increase from baseline to one-
year in the intervention clinics but not usual care clinics (the effect of intervention fidelity: being exposed to 
the AH-HA tool). We will similarly use linear mixed effects models to compare the change in CVH risk 
factors (BMI, cholesterol, blood pressure, etc.) between the study groups including baseline levels of these 
risk factors as a covariate in the mixed models. We will conduct sensitivity analyses using multiple 
imputation to examine the effect of missing follow-up data on inference for these analyses.    
 

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10.6 
Analysis Plan for Key Informant Interviews 
 
Key Informant Interview analyses will be descriptive in nature and will help determine strategies for future 
dissemination and implementation of the AH-HA tool. The results of this aim will also be used more 
generally to inform best practices for EHR-based tool implementation in community-based oncology clinics. 
Interview transcripts will be analyzed using ATLAS.ti software (Atlas.ti Scientific Software Development) 
and follow the principles and procedures of thematic analysis (TA). TA is a rigorous and widely-used 
approach that identifies, categorizes, and contextualizes patterns of key themes and explores behavior, 
interpretation, and consequences of experiences114. Thematic statements regarding barriers and acceptability 
of future AH-HA tool maintenance or implementation will be generated to summarize key ideas while also 
preserving the complexity of inter-related ideas. These statements will seek to integrate information 
regarding barriers and facilitators with information regarding practice and provider characteristics and the 
likelihood of future implementation. Drs. Weaver and Lee will oversee trained Q-PRO staff within the Q-
PRO to produce a description of key themes and supporting quotes, a methodology previously implemented 
by Drs. Weaver and Foraker.115 
 
10.7 
Evaluation of Response 
 
All participants with a completed baseline post-visit survivor survey will be included in final analysis for 
survivors. Key informant analyses will include all surveys and interviews conducted. 
 
 
 
11. 
REGISTRATION PROCESS 
 
11.1 
Investigator and Research Associate  Registration with CTEP 
Food and Drug Administration (FDA) regulations and National Cancer Institute (NCI) policy require all 
individuals contributing to NCI-sponsored trials to register and to renew their registration annually.  To 
register, all individuals must obtain a Cancer Therapy Evaluation Program (CTEP) Identity and Access 
Management (IAM) account at https://ctepcore.nci.nih.gov/iam.  In addition, persons with a registration type 
of Investigator (IVR), Non-Physician Investigator (NPIVR), or Associate Plus (AP) must complete their 
annual registration using CTEP’s web-based Registration and Credential Repository (RCR) at 
https://ctepcore.nci.nih.gov/rcr.   
RCR utilizes five person registration types: 
• 
IVR — MD, DO, or international equivalent; 
• 
NPIVR — advanced practice providers (e.g., NP or PA) or graduate level researchers (e.g., PhD); 
• 
AP — clinical site staff (e.g., RN or CRA) with data entry access to CTSU applications such as the 
Roster Update Management System [RUMS], OPEN, Rave, acting as a primary site contact, or with 
consenting privileges; 
• 
Associate (A) — other clinical site staff involved in the conduct of NCI-sponsored trials; and 
• 
Associate Basic (AB) — individuals (e.g., pharmaceutical company employees) with limited 
access to NCI-supported systems. 
 

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RCR requires the following registration documents: 
Documentation Required 
IVR NPIVR AP 
A 
AB 
FDA Form 1572 
✔ 
✔ 
Financial Disclosure Form 
✔ 
✔ 
✔ 
 
 
NCI Biosketch (education, training, employment, license, and 
certification) 
✔ 
✔ 
✔ 
GCP training 
✔ 
✔ 
✔ 
Agent Shipment Form (if applicable) 
✔ 
CV (optional) 
✔ 
✔ 
✔ 
 
An active CTEP-IAM user account and appropriate RCR registration is required to access all CTEP and 
Cancer Trials Support Unit (CTSU) websites and applications.  In addition, IVRs and NPIVRs must list all 
clinical practice sites and Institutional Review Boards (IRBs) covering their practice sites on the FDA Form 
1572 in RCR to allow the following: 
• 
Addition to a site roster; 
• 
Assign the treating, credit, consenting, or drug shipment (IVR only) tasks in OPEN; 
• 
Act as the site-protocol  Principal Investigator (PI) on the IRB approval; and 
• 
Assign the Clinical Investigator (CI) role on the Delegation of Tasks Log (DTL).     
 
In addition, all investigators acting as the Site-Protocol PI (investigator listed on the IRB approval), 
consenting/treating/drug shipment investigator in OPEN, or as the CI on the DTL must be rostered at the 
enrolling site with a participating organization. Additional information is located on the CTEP website at 
https://ctep.cancer.gov/investigatorResources/default.htm.  For questions, please contact the RCR Help 
Desk by email at RCRHelpDesk@nih.gov. 
 
Protocol documents are found on the CTSU website, but supplemental documents may be available on the 
Wake Forest NCORP Research Base website.  
 
11.2 
Cancer Trials Support Unit Registration Procedures 
 
Protocol documents are found on the CTSU website, but additional supplemental documents may be 
available on the Wake Forest NCORP Research Base website 
(https://wakencorp.phs.wakehealth.edu/dspLogin.cfm). 
 
This study is supported by the NCI CTSU. 
 
IRB Approval 
 
For CTEP and Division of Cancer Prevention (DCP) studies open to the National Clinical Trials Network 
(NCTN) and NCI Community Oncology Research Program (NCORP) Research Bases after March 1, 2019, 
all U.S.-based sites must be members of the NCI Central Institutional Review Board (NCI CIRB). In 
addition, U.S.-based sites must accept the NCI CIRB review to activate new studies at the site after March 
1, 2019. Local IRB review will continue to be accepted for studies that are not reviewed by the CIRB, or if 
the study was previously open at the site under the local IRB. International sites should continue to submit 
Research Ethics Board (REB) approval to the CTSU Regulatory Office following country-specific 

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regulations.  
 
Sites participating with the NCI CIRB must submit the Study Specific Worksheet (SSW) for Local Context  
to the CIRB using IRBManager to indicate their intent to open the study locally. The NCI CIRB’s approval 
of the SSW is automatically communicated to the CTSU Regulatory Office, but sites are required to contact 
the CTSU Regulatory Office at CTSURegPref@ctsu.coccg.org to establish site preferences for applying 
NCI CIRB approvals across their Signatory Network. Site preferences can be set at the network or protocol 
level. Questions about establishing site preferences can be addressed to the CTSU Regulatory Office by 
emailing the email address above or calling 1-888-651-CTSU (2878). 
 
In addition, the site-protocol Principal Investigator (PI) (i.e. the investigator on the IRB/REB approval) 
must meet the following criteria in order for the processing of the IRB/REB approval record to be 
completed: 
• 
Holds an active CTEP status; 
• 
Active status at the site(s) on the IRB/REB approval  on at least one participating 
organization’s roster; 
• 
If using NCI CIRB, active on the NCI CIRB roster under the applicable CIRB Signatory 
Institution’s record; 
• 
Includes the IRB number of the IRB providing approval in the  Form FDA 1572 in the RCR 
profile;  
• 
Lists all sites on the IRB/REB approval as Practice Sites in the Form FDA 1572 in the RCR 
profile; and 
• 
Holds the appropriate CTEP registration type for the protocol.  
 
Additional Requirements 
 
Additional site requirements to obtain an approved site registration status include: 
• 
An active Federal Wide Assurance (FWA) number; 
• 
An active roster affiliation with the Lead Protocol Organization (LPO) or a Participating 
Organization (PO);  
• 
An active roster affiliation with the NCI CIRB roster under at least one CIRB Signatory 
Institution (US sites only); and 
• 
Compliance with all protocol-specific requirements (PSRs). 
 
Protocol Specific Requirements For WF-1804CD Site Registration: 
 
• 
NCI CIRB approval of the Site Submission Worksheet – all participating sites must use the 
NCI CIRB as their IRB of record for WF-1804CD. 
• 
Site Open to Enrollment (SOTE) letter from WF NCORP RB, which is provided to the site 
once sites have completed all site set up activities. 
 
Practice Level Data Collection Form – The enrolling affiliate/subaffiliate will complete the NCORP 
Practice Level Data Collection Form and submit it to the CTSU Regulatory Office as a Specific Sites only 
submission using the Regulatory Submission Portal located in the Regulatory section of the CTSU website. 
The form will collect various attributes about the enrolling affiliate/subaffiliate. All of the questions on the 
form must be complete and the distribution for the analytic cases question must equal 100%. (See form for 
directions). The form must be received and complete for site registration approval in RSS. The NCORP 
Practice Level Data Collection Form requirement is submitted once for participation on all NCORP Cancer 

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Care Delivery (CCDR) trials, but will expire two years after it is received. NCORP sites will need to resubmit 
the Practice Level Data Form to the CTSU in order to continue to enroll to CCDR trials.  
 
Upon site registration approval in RSS, the enrolling site may access OPEN to complete enrollments. The 
enrolling site will select their credentialed provider treating the subject in the OPEN credentialing screen, 
and may need to answer additional questions related to treatment in the eligibility checklist.   
 
Submitting Regulatory Documents:  
 
Submit required forms and documents to the CTSU Regulatory Office via the Regulatory Submission Portal 
on the CTSU members’ website.  
 
To access the Regulatory Submission Portal log in to the CTSU members’ website, go to the Regulatory 
section and select Regulatory Submission. 
 
Institutions with patients waiting that are unable to use the Regulatory Submission Portal should alert the 
CTSU 
Regulatory Office immediately by phone 
or email: 1-866-651-CTSU (2878), or 
CTSURegHelp@coccg.org in order to receive further instruction and support.  
 
Checking Site’s Registration Status: 
 
Site’s registration status may be verified on the CTSU members’ website.   
 
 
• 
Click on Regulatory at the top of the screen;  
• 
Click on Site Registration;and 
• 
Enter the sites 5-character CTEP Institution Code and click on Go. 
o Additional filters are available to sort by Protocol, Registration Status, Protocol Status, 
and/or IRB Type. 
 
Note: The status shown only reflects institutional compliance with site registration requirements as outlined 
within the protocol. It does not reflect compliance with protocol requirements for individuals participating 
on the protocol or the enrolling investigator’s status with NCI or their affiliated networks. 
 
 
11.3     Patient Enrollment  
 
The Oncology Patient Enrollment Network (OPEN) is a web-based registration system available on a 24/7 
basis. OPEN is integrated with CTSU regulatory and roster data and with the  LPOs 
registration/randomization systems or the Theradex Interactive Web Response System (IWRS) for retrieval 
of patient registration/randomization assignment. OPEN will populate the enrollment data in WF NCORP 
RB’s clinical data management system, REDCap.   
 
Requirements for OPEN access: 
• 
A valid CTEP-IAM account;  

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• 
To perform enrollments or request slot reservations:  Must be on an LPO roster, ETCTN 
corresponding roster, or participating organization PO roster with the role of Registrar. 
Registrars must hold a minimum of an Associate Plus registration type; 
• 
If a Delegation of Tasks Log (DTL) is required for the study, the registrar(s) must hold the 
OPEN Registrar task on the DTL for the site; and 
• 
Have an approved site registration for the protocol prior to patient enrollment. 
 
To assign an Investigator (IVR) or Non-Physician Investigator (NPIVR) as the treating, crediting, 
consenting, drug shipment (IVR only), or receiving investigator for a patient transfer in OPEN, the IVR or 
NPIVR must list the IRB number used on the site’s IRB approval on their Form FDA 1572 in RCR. If a 
DTL is required for the study, the IVR or NPIVR must be assigned the appropriate OPEN-related tasks on 
the DTL. 
Prior to accessing OPEN, site staff should verify the following: 
• 
Patient has met all eligibility criteria within the protocol stated timeframes; and  
• 
All patients have signed an appropriate consent form and Health Insurance Portability and 
Accountability Act (HIPAA) authorization form (if applicable). 
Note: The OPEN system will provide the site with a printable confirmation of registration and treatment 
information. You may print this confirmation for your records.  
Access OPEN at https://open.ctsu.org or from the OPEN link on the CTSU members’ website. Further 
instructional information is in the OPEN section of the CTSU website at https://www.ctsu.org or 
https://open.ctsu.org. For any additional questions, contact the CTSU Help Desk at 1-888-823-5923 or 
ctsucontact@westat.com. 
 
Non-patient Provider and/or Other Professional Discipline enrollments, for this trial will be completed using 
OPEN. All OPEN access requirements apply to non-patient enrollments in OPEN.  
 
Prior to enrollment, site staff should verify the following: 
• 
Non-patient participant has met all eligibility criteria within the protocol stated timeframes; and  
• 
All non-patient participants have signed an appropriate consent form and HIPAA authorization 
form (if applicable) 
 
In the OPEN credentialing screen, select the registration type of non-patient and select the applicable non-
patient type Provider and/or Other Professional Discipline. Complete the non-patient enrollment prerequisite 
questions and the associated eligibility checklist and submit the enrollment. The OPEN system will provide 
the site with a printable confirmation of the non-patient registration and additional instructions as needed. 
Please print this confirmation for your records.  
 
11.4  Data Submission / Data Reporting  
 
REDCap is a clinical data management system being used for data collection for this trial/study. Access to 
the trial in REDCap is granted through Wake Forest NCORP Research Base.  
Requirements to access REDCap:  
• 
A valid CTEP-IAM account; and  
• 
Must have a minimum of an Associate Plus (AP) registration type;  
• 
Must be on the Wake Forest NCORP Research Base roster in NCORP-SYS for active study sites 

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Refer to https://ctep.cancer.gov/investigatorResources/default.htm for registration types and documentation 
required. 
 
Upon initial site registration approval for the study in Regulatory Support System (RSS), all persons on the 
Study Site Role form from  the Study Start-up Packet needing database access will be sent a study invitation 
e-mail from REDCap with instructions for access. Please note, site users will not be able to access the study 
in REDCap until all required study specific trainings are completed.   
 
For any additional questions on REDCap contact the Wake Forest NCORP Research Base at 336-716-0891 
or NCORP@wakehealth.edu. 
 
11.5 
Informed Consent 
 
All potential survivor participants will be consented with a Survivor Consent Script whether they are 
consented virtually, by telephone, or in-person. The study has requested a waiver of documentation of 
consent for survivor participants. Provider key informants will give their consent by reading the provider 
key informant consent in REDCap and proceeding to the Post-Training Provider Structured Survey 
questions. Administrator/IT specialist key informants will give their consent by reading the administrator/IT 
specialist consent and proceeding to the Eligibility, Demographic & Background questions. Participants 
will be given a copy of the IRB-approved Informed Consent information to review, if requested. The 
investigator or other designated study staff will explain all aspects of the study in lay language and answer 
all questions regarding the study. Subjects who refuse to participate or who withdraw from the study will be 
treated without prejudice. 
 
Prior to study initiation, the informed consent document must be reviewed and approved by NCI, DCP and/or 
DCCPS, the Wake Forest NCORP Research Base, and the NCI CIRB. Each Organization at which the 
protocol will be implemented will also need to get approval from the NCI CIRB to participate in the study.  
Any subsequent changes to the informed consent must be approved by NCI, DCP, Wake Forest NCORP 
Research Base and the NCI CIRB. All approved changes are then implemented by each local organization 
in the required time period and if required locally, submitted to each organization’s local IRB for approval 
prior to initiation. 
 
11.6 
Other 
 
This trial will be conducted in compliance with the protocol, Good Clinical Practice (GCP), and the 
applicable regulatory requirements. 
 
 
 
 

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APPENDIX A: VIRTUAL VISIT CONSIDERATIONS 
 
For both usual care and intervention sites, the designated AH-HA appointment may be conducted virtually 
only if the survivorship care visit is already scheduled as a virtual visit; otherwise, the designated AH-HA 
appointment should be conducted in-person.  
 
For intervention sites only, the provider and participant must be able to videoconference with screen sharing 
that shows the participant the AH-HA tool.  
 
Considerations for virtual visits are listed below: 
 
Recruitment and Consenting 
 
• 
Eligibility: Because surveys can only be completed online via REDCap in English, Spanish 
speakers/readers will be able to participate in the study only if study sites can meet the following 
requirements: 
o Mail paper copies of the surveys in Spanish prior to the designated AH-HA appointment so that 
the survivor can complete and return the Pre-visit Baseline Survivor Survey within the two 
week window prior the designated AH-HA appointment. 
o Have a Spanish-speaking provider conduct the designated AH-HA appointment or include an 
interpreter in the virtual visit videoconference. 
o Conduct the Post-visit Baseline Survivor Survey by phone with a Spanish-speaking staff 
member or interpreter within 48 hours of the designated AH-HA appointment or mail paper 
copies of the surveys in Spanish prior to the  appointment so that the survivor can complete the 
Post-visit Baseline Survivor Survey immediately after the appointment. 
 
• 
Screening: Local NCORP site staff should screen schedules for survivorship care virtual visits to identify 
participants who would need to be contacted virtually for study invitation and consenting. 
 
• 
Email Collection: 
 
o Survivor emails will be collected during recruitment and added to the Site Info Entry form in 
REDCap in order for the surveys to be emailed to the participant.  
 
o Provider key informant emails need to be collected during recruitment and entered into the Site 
Info Entry form in order to receive the diet and exercise status answers that the participant 
provides (see Diet and Exercise Status under the Designated AH-HA Appointment section 
below).  
 
• 
Consenting: The study has requested a waiver of documentation of consent for all participants. The 
Survivor Consent Script provides a telephone/teleconference script for virtual or telephone consent. 
 
 
 

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Designated AH-HA Appointment 
 
• 
AH-HA Patient Notification: The AH-HA Patient Notification form is intended to remind the provider 
to use the AH-HA tool with the patient during an in-person designated AH-HA appointment. 
However, for virtual visits, this physical reminder is not possible, so sites should flag that the patient is 
an AH-HA study participant somewhere in the EHR and/or scheduling module.  
 
• 
Vitals Collection: Sites can ask in their virtual visit reminders for the survivor to provide as many AH-
HA specific vitals as possible that they can conduct safely at home (weight and blood pressure). In the 
absence of day-of vitals, the AH-HA tool will pull the most recent data stored in the EHR. 
 
• 
Diet and Exercise Status: For virtual visits, answers to the two diet and exercise questions will be 
automatically pulled from the Pre-visit Baseline Survivor Survey into a separate REDCap form and 
emailed to the provider. 
 
• 
Medical Record Abstraction: Local site staff should record the format of the designated AH-HA 
appointment (in-person or virtually via telephone or video) and the reason why on the Medical Record 
Data Form in REDCap. This will be completed after the survivor completes the Post-visit Baseline 
Survivor Survey. 
 
 
 
 

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