Expanding Rural Health Cancer Control Capacity: Focus on Cancer Survivorship
Phase: NA
Conditions: Cancer
Sponsor: Debra Friedman

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EXPANDING RURAL HEALTH CANCER CONTROL CAPACITY: 
FOCUS ON CANCER SURVIVORSHIP 
STUDY PROTOCOL 
NCT04765072
Principal Investigator: 
Debra Friedman, MD, MS 
Professor of Pediatrics 
E. Bronson Ingram Chair in Pediatric Oncology
Director, Division of Pediatric Hematology/Oncology 
Co-Leader, Cancer Health Outcomes and Control 
Vanderbilt-Ingram Cancer Center 
 
 

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TABLE OF CONTENTS 
1. Overview and Specific Aims ........................................................................................................3 
2. Background and Study Rationale ................................................................................................3 
3. Research Design and Methods ...................................................................................................3 
   3.1. IRB Approval    
   3.2. Study Population  
   3.3. Patient Eligibility Criteria 
   3.4. Research Procedures 
   3.5. Study Timeline  
   3.6. Process Evaluation and Analysis 
4. Research Team ...........................................................................................................................8 
5. Potential Risks .............................................................................................................................8 
6. Potential Benefits .........................................................................................................................8 
7. Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants or
Others...............................................................................................................................................8 
8. Study Withdrawal/Discontinuation ...............................................................................................9 
9. Privacy/Confidentiality Issues ..................................................................................................... 9 
10. Follow-up and Record Retention ...............................................................................................9 
11. References...............................................................................................................................10 

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STUDY PROTOCOL 
1. OVERVIEW AND SPECIFIC AIMS
Through this pilot study, we will test an innovative approach to implement survivorship care 
planning at three sites in the Baptist Memorial Health Care Corporation (BMHC) located in or 
adjacent to rural counties in our catchment area. The pilot data will inform a subsequent multi-site 
Hybrid Type 3 Implementation-Effectiveness study that will assess both implementation and 
clinical effectiveness outcomes. The overall goal of this study is to improve long term health 
outcomes for underserved rural cancer survivors by building capacity of rural health systems, in 
collaboration with an NCI-designated comprehensive cancer center, to deliver risk-adapted 
guideline-based care focused on the unique needs of cancer survivors. To accomplish this goal, 
we will address two specific aims.  
1. Pilot test the implementation of guideline-based survivorship care planning in a rural
setting using patient navigation plus telehealth among underserved rural cancer survivors.
We will collect feasibility data on patient recruitment rates and the ability to measure
clinical effectiveness outcomes using the electronic health record and patient reports
(survivor adherence to recommended disease surveillance, health assessment and
cancer prevention/early detection practices).
2. Identify the facilitators and barriers to future larger scale implementation of guideline-
based survivorship care planning in rural settings to optimize the implementation
strategies. Through a mixed methods approach, we will address implementation research
questions focused on “real world” implementation of the guideline-based intervention in
rural areas, including barriers/facilitators and translation to other rural settings. This will
allow us to optimize the implementation strategies that will be further evaluated in the
future large-scale implementation trial.
2. BACKGROUND AND STUDY RATIONALE
For those living in rural areas who are successfully treated for cancer, little is known on how to 
best address the potential long-term health burden, including need and accessibility of cancer 
and control services1-2. Research is required on how to best implement guideline-based, locally 
accessible survivorship care to rural cancer survivors. Leveraging the expertise of an NCI-
designated comprehensive cancer center with a large rural population [such as the Vanderbilt-
Ingram Cancer Center (VICC)] can help build capacity to attain this goal. Through this study, we 
will improve our understanding of the needs of cancer survivors in rural communities in the VICC 
catchment area and optimize promising implementation strategies that could help rural healthcare 
facilities overcome challenges to delivering guideline-based survivorship care planning and 
delivery. Further, we will enhance our capacity to bring cancer prevention and control research, 
education and services to this population.  
3. RESEARCH DESIGN AND METHODS
3.1 IRB Approval
Each clinical site must obtain IRB approval for this protocol and submit IRB approval and 
supporting documentation to the Coordinating Center before they can be approved to enroll 
patients. Centers will use the sIRB mechanism with Vanderbilt-Ingram Cancer Center (VICC) as 
the coordinating center.  

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3.2. Study Population 
This pilot study population will include the following individuals selected from healthcare sites 
within the BMHC, serving a rural population: 
a. Post-treatment cancer patients
b. Oncology providers
c. BMHC healthcare staff
3.3. Patient Eligibility Criteria 
1. Cancer patient at least 18 years of age at time of cancer therapy and English-speaking
with the ability to provide informed consent
2. Received treatment for Stage 0 – III cancer with curative intent
3. Completed cancer therapy within the previous 12 months (i.e., 12 months prior to
consenting) and in complete remission
3.4. Research Procedures 
The pilot study will use a mixed methods approach to assess the implementation of guideline-
based survivorship care planning in a rural setting. Both quantitative (QUAN) and qualitative 
(QUAL) data will be collected in a sequential order through surveys and interviews.  
Patient Recruitment, Enrollment, & Data Collection 
Study Sites: 
•
Cancer clinics within the Baptist Memorial Health Care Corporation
The VICC study team will communicate with designated BMHC staff at the study sites to identify 
cancer patients eligible for this study and their treating BMHC oncology provider. The VICC study 
team will contact the identified oncology provider(s) or staff to offer information about the patient 
intervention, which includes (1) local patient navigation and (2) telehealth-facilitated delivery of 
survivorship care, and request that provider gather interest from their patient in participating. If 
the patient expresses interest in participating, a participating BMHC oncology provider and/or 
research staff will talk to the patient further about the study. The VICC study team may contact 
the patient by mail, email, phone, or in person to provide additional information about the study, 
if needed. If the patient is willing to participate, BMHC research staff will confirm the patient’s 
eligibility based on the aforementioned criteria, then prompt them to complete the study’s required 
informed consent form either on paper or online through REDCap.  
Consented patient participants will then be asked to complete a Patient Demographic Survey and 
the National Comprehensive Cancer Network (NCCN) Distress Thermometer Survey5 online 
through REDCap, on paper, or over the phone.  
Survivorship Patient Navigation Intervention: Participants will then be assigned to a patient 
navigator to assist the participant either in person, by email, or over the phone with navigation of 
the fragmented healthcare system and help survivors find and utilize resources and services, 
available locally or through VICC, if not locally available, to meet identified follow-up 
recommendations.  
Telehealth Survivorship Visit Intervention: The designated patient navigator will schedule for the 
participant, at their convenience, a telehealth survivorship visit with a REACH nurse practitioner 
and a research nurse who will review a survivorship care plan (SCP) with the participant based 
on their medical history and review of medical records. REACH is the cancer survivorship program 

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offered through VICC. Following the telehealth visit, the SCP will be finalized, and a copy shared 
digitally (or in print, if needed) with the participant, the treating oncology provider(s), the 
participant’s primary care provider, and other care providers requested by the participant. The 
REACH nurse practitioner and patient navigator will work together to advise and assist the 
participant and their care team in recommended follow-up, including services available locally or 
through VICC via telehealth. The patient navigator will also assist the participant with follow-up 
logistics.   
Three months post the aforementioned telehealth survivorship visit, participants will be asked to 
complete the NCCN Distress Thermometer Survey5 and the Patient Post-Intervention REACH 
Satisfaction Survey to rate the quality and salience of the survivorship care planning to their 
specific needs and their overall satisfaction with the program. The Patient Post-Intervention 
REACH Satisfaction Survey will assess perceived utility, benefit, accessibility importance and 
favorability. Qualitative (open-ended) items will ask for feedback on aspects of the program they 
liked most, how it could be improved, and any challenges with receiving survivorship care via 
telehealth. All surveys may be completed either on paper, online through REDCap, or over the 
phone. 
A sub-group of up to 20 participants will be asked to complete interviews and/or focus groups 
after completion of the telehealth survivorship visit. Interviews and/or focus groups will be audio 
recorded, using a semi-structured interview guide. Participants who complete an interview and/or 
focus group will receive a $25 gift card in compensation for their time. The interview questions 
are adapted from the existing CFIR Interview Guide, covering the selected constructs appropriate 
for the population. As Survivorship Care Plans (SCPs) do not appear to improve outcomes in and 
of themselves, we will focus on what factors positively or negatively affected recommended follow-
up. 
Patient Timeline 
Timepoint 
Action 
Recruitment 
Recruited through a referral by their 
oncologist, then study personnel will 
inform patient of study 
Enrollment 
Patient will sign required consent form. 
Patient Demographic Survey and 
NCCN Distress Thermometer Survey5 
will be administered 
Telehealth & Survivorship Navigation 
Program 
Participation in intervention 
Post-telehealth intervention 
Patient Post-Intervention REACH 
Satisfaction Survey and NCCN 
Distress Thermometer Survey5 
administered 3 months after 
intervention 
End of Study 
Participation in qualitative interviews 
and/or focus groups 
Month 12
Month 1

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BMHC Oncology Providers & Staff Data Collection 
BMHC oncology providers or staff who have referred a consented patient participant to the study 
will be asked to review an information sheet and consent to completing a Provider Demographic 
Survey to collect basic demographic information online through REDCap, on paper, or over the 
phone. 
Three months after the patient participant referred by the oncologist or staff member has 
completed the telehealth survivorship visit, the provider or staff member will be asked to complete  
the Provider Post-Intervention REACH Satisfaction Survey online through REDCap, on paper, or 
over the phone to assess perceived utility, benefit, accessibility importance and favorability. 
Qualitative (open-ended) items will ask for feedback on aspects of the program they liked most, 
how it could be improved, and any challenges with receiving survivorship care via telehealth.  
A sub-group of six oncology providers and 12 staff will be asked to complete key informant 
interviews and/or focus groups. Providers or staff who complete an interview and/or focus group 
will receive a $25 gift card in compensation for their time. The interview questions are adapted 
from the existing CFIR Interview Guide, covering the selected constructs appropriate for the 
population. As Survivorship Care Plans (SCPs) do not appear to improve outcomes in and of 
themselves, we focus on what factors positively or negatively affected recommended follow-up. 
BMHC Provider/Staff Timeline 
3.5 Study Timeline 
Timepoint 
Action 
Timepoint 
Action 
Recruitment 
Study personnel will reach out to 
providers/staff to inform them of the 
study. If interested, the provider/staff 
will inform their patient 
Enrollment 
Provider/staff will review a required 
information sheet. Provider 
Demographic Survey administered 
Telehealth & Survivorship Navigation 
Program 
N/A 
Post-telehealth intervention 
Provider Post-Intervention REACH 
Satisfaction Survey administered 
End of Study 
Participation in qualitative interviews 
and/or focus groups 
Month 12
Month 1

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Notification of Grant Award 
Study Coordinator and patient navigators will 
be hired 
Three sites within BMHC will be confirmed 
Months 1-3 
Navigators may receive VICC’s existing lay 
patient navigation training and may 
participate in the GWCI “Oncology Patient 
Navigator Training: The Fundamentals” 
Months 4-12 
Survivorship Care Plans will be created and 
delivered via telehealth by REACH nurse 
practitioner and a research nurse 
Patient navigator will assist patient with needs 
and identifying local resources 
Surveys will be administered, and data will be 
collected and evaluated from them 
Assessment of barriers and facilitators will 
take pace  
3.6. Process Evaluation and Analysis 
Process Evaluation Data: Implementation penetration will be assessed as a ratio of number of 
patients who participate in survivorship care planning divided by total number of potential 
participants approached at each recruitment site. To address implementation fidelity, we will 
examine adherence of navigators and nurses to facilitate the process following the protocol set 
forth using an adapted Fidelity Checklist3. Participant responsiveness will be measured as 
satisfaction with the survivorship care planning from the post surveys. 
Data Analysis. We will use a connecting process to combine both types of data through 
complementarity, using the qualitative data to explain the quantitative outcomes in more detail. 
Descriptive analyses will be used for the quantitative data. Qualitative software will be used to 
code the interview transcripts using the CFIR Codebook Template4. We will use thematic analysis 
method to identify and analyze commonly recurring themes. 
Feasibility data on patient recruitment rates and the ability to successfully measure relevant 
clinical effectiveness outcomes will be collected. Through electronic health records and participant 
surveys, we will retrospectively review the following clinical effectiveness outcomes: survivor 
adherence to recommendations made as part of survivorship planning, including disease specific 
follow-up, cancer screening and risk-based health promotion.  
4. RESEARCH TEAM
Debra Friedman, MD, MS, Principal Investigator
Co-investigators:
Tuya Pal, MD
Research Staff:
Claudia Barajas
Denise Martinez
Jacob McArthy, MS

 
 
 
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Kelsey Minix, MPH 
Emma Schremp, MS 
Ann Tezak, MA, MPH 
Anne Washburn, MPH 
5. POTENTIAL RISKS 
 
There is a slight risk of accidental release of confidential information. The study team attempts 
to minimize this risk by limiting access to PHI. All confidential records that could identify subjects 
will be protected, respecting the privacy and confidentiality rules in accordance with the IRB’s 
regulatory requirements. The study team will perform the study according to good clinical 
practices. 
 
6. POTENTIAL BENEFITS 
 
There are no direct benefits to participants from participating in this study. However, the benefits 
to science and humankind that may result from this study are that the data obtained may inform 
therapy for patients in the future and surveillance and secondary prevention interventions to 
avoid adverse long-term outcomes for current long-term survivors. 
 
7. REPORTING OF ADVERSE EVENTS OR UNANTICIPATED PROBLEMS INVOLVING RISK 
TO PARTICIPANTS OR OTHERS 
No adverse events are anticipated for this study. Although no adverse events are anticipated for 
this study, the PI will report any adverse events to the IRB immediately. 
8.  STUDY WITHDRAWAL/DISCONTINUATION 
Participants are free to stop participating at any time without penalty. Participants may also 
choose not to answer any questions that make them feel uncomfortable.  
9. PRIVACY/CONFIDENTIALITY ISSUES 
Telehealth and Survivorship Patient Navigation: Telehealth visit conducted via HIPPA 
compliant software. 
Surveys: Only study personnel will have access to the information collected on paper surveys. 
Questionnaires completed online or collected over the phone will be directly entered into the 
secure, password-protected REDCap database for the respective participant’s record. ID 
numbers will be assigned to surveys with access only to study personnel. 
Qualitative Interviews: The digital audio recordings will be stored on password protected 
computers until they are transcribed, with access only available to study personnel.  
 
10. FOLLOW-UP AND RECORD RETENTION 
 
Surveys: ID numbers will be assigned to surveys with access only to study personnel. Online 
data will be stored on a secure REDCap database. 
 
Qualitative Interviews: The digital audio recordings will be stored on password protected 
computers until they are transcribed, with access only available to study personnel. After the 
information is transcribed, the recordings will be deleted. 

 
 
 
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11. REFERENCES  
 
1. American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 
2019 
2. Aziz, NM, Rowland, JH, Cancer survivorship research among ethnic minority and medically 
underserved groups. Oncol Nurs Forum, 2002. 29(5):789-801. 
3. Breitenstein SM, Fogg L, Garvey C, Hill C, Resnick B, Gross D. Measuring implementation 
fidelity in a community-based parenting intervention. Nursing Research. 2010;59:158-65 
4. Consolidated Framework for Implementation Research. Center for Clinical Management 
Research. 2018; 2018 
5. National Comprehensive Cancer Network. Distress Thermometer Scale. September 7, 2018. 
http://www.nccn.org/professionals/physician_gls/pdf/distress.pdf.