SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic Systems in Survivorship
Phase: NA
Conditions: Cancer, Survivorship, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Sponsor: Wake Forest University Health Sciences

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
CT.gov:  NCT04337203 
 
Protocol version date 09/15/21 
 
 
 
Principal Investigator: 
 
Stephanie Jean Sohl, PhD 
Department of Social Sciences and Health Policy 
Division of Public Health Sciences 
Wake Forest School of Medicine 
Medical Center Boulevard, Winston-Salem, NC 27157 
 
 
Co-Investigator(s):  
 
Stacy Wentworth, MD 
Department of Radiation Oncology 
Wake Forest Baptist Medical Center 
Medical Center Boulevard, Winston-Salem, NC 27157 
 
Kate Weaver, PhD 
Department of Social Sciences and Health Policy 
Division of Public Health Sciences 
Wake Forest School of Medicine 
Medical Center Boulevard, Winston-Salem, NC 27157 
 
 
Thomas Houston, MD 
Department of Internal Medicine 
Wake Forest Baptist Medical Center 
Medical Center Boulevard, Winston-Salem, NC 27157 
 
Rajani Sadasivam, PhD 
Division of Health Informatics, Population and 
Quantitative Health Sciences 
University of Massachusetts Medical School 
 
 
Biostatistician: 
Emily Dressler, PhD  
Comprehensive Cancer Center of Wake Forest 
University 
Wake Forest University School of Medicine 
Medical Center Blvd, Winston-Salem, NC 27157 
 
 
 
 
Study Coordinator: 
 
Rebecca Dellinger-Johnston, MS 
Department of Social Sciences and Health Policy 
Division of Public Health Sciences 
Wake Forest School of Medicine 
Medical Center Boulevard, Winston-Salem, NC 27157 
 
 

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
CT.gov:  NCT04337203 
 
Protocol version date 09/15/21 
 
 
Regulatory Contact: 
 
Rebecca Dellinger-Johnston, MS 
Department of Social Sciences and Health Policy 
Division of Public Health Sciences 
Wake Forest School of Medicine 
Medical Center Boulevard, Winston-Salem, NC 27157 
 
Intervention Fidelity  
 
Rebecca Weinand, NBC-HWC 
Reviewer: 
 
 
 
National Board Certified – Health & Wellness Coach 
 
 
 
 
 
 
 
 
 
 
Participating Institution(s): Wake Forest School of Medicine and University of 
Massachusetts Medical School 
 
 
Version Date: September 15, 2021 
 
Amended: 
 
 
 
Confidential

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
Protocol version date 09/15/21 
Page 3 of 26 
 
 
 
Table of Contents 
1.0 Summary ............................................................................................................................. 4 
2.0 
Introduction and Background .......................................................................................... 4 
3.0 
Objectives ...................................................................................................................... 8 
3.1 
Primary Objective ....................................................................................................... 8 
3.2 
Secondary Objective................................................................................................... 9 
4.0 
Patient Selection ............................................................................................................ 9 
4.1 
Inclusion Criteria ........................................................................................................10 
4.2 
Exclusion Criteria .......................................................................................................10 
4.3 
Inclusion of Women and minorities ............................................................................10 
5.0 
Methods ........................................................................................................................11 
5.1 
Registration Procedures ............................................................................................11 
5.2 
Study-Related Activities .............................................................................................11 
Overview of Study-Related Activities .....................................................................................11 
6.0 
Outcome Measures .......................................................................................................13 
6.1 
Primary Outcome .......................................................................................................14 
6.2 
Secondary Outcomes ................................................................................................14 
7.0 
Analytic Plan..................................................................................................................15 
7.1 
Sample Size and Power ............................................................................................15 
7.2 
Data Analyses ...........................................................................................................16 
7.3 
Accrual Rate ..............................................................................................................17 
7.4 
Length of Study .........................................................................................................18 
8.0 
Data Management .........................................................................................................18 
9.0 
Confidentiality and Privacy ............................................................................................18 
10.0 
Data Safety and Monitoring ...........................................................................................19 
11.0 
Reporting of Unanticipated Problems, Adverse Events or Deviations ............................20 
Appendix A – Subject Eligibility Checklist ............................................................................25 
Appendix B – Protocol Reduced Review Registration Form ...............................................26 
 
 

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
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1.0 Summary 
 
Nationally, there is a recognized gap in implementing guideline-concordant cancer 
survivorship care planning (SCP). Initial SCP guideline implementation efforts focused 
on document/information delivery and demonstrated limited efficacy for improving 
patient health outcomes. The proposed SHARE-S Implementation Program builds upon 
successful SCP studies based on the Chronic Care Model and aims to enhance SCP 
implementation, leveraging technology. SHARE-S will enhance SCP with self-
management coaching and text/coaching support for adherence to the SCP guidelines 
that require self-management. We will conduct a single-arm pragmatic pilot study of 
SHARE-S implemented in clinical care (n=40). We will test the study protocols, 
implementation program, and complete mixed-methods data collection to guide future 
study planning. The primary goal of this study is to assess how successfully SHARE-S 
can be implemented in a clinical setting that already consistently provides survivorship 
care planning documents to improve guideline concordant survivorship care. We will also 
collect data on the feasibility of assessing the impact of SHARE-S on service outcomes 
and patient outcomes. The primary goal of the future larger study will be to assess 
SHARE-S in multiple clinical settings to improve implementation of guideline concordant 
survivorship care and thus patient health outcomes. SHARE-S is a novel approach to 
supporting patient self-management that is integrated with clinical care and may 
generalize to improving care for other chronic illnesses such as cardiovascular disease. 
2.0 
Introduction and Background 
 
The transition from active cancer treatment to survivorship is a particularly 
challenging time with an opportunity to improve upon guidance for how patients 
can take a more active role to optimize their health outcomes.3 Survivorship care 
planning (SCP) supports the transition from active cancer care to survivorship 
care by enhancing communication among clinical teams and empowering 
patients and families. Nationally, there is a recognized gap in implementing 
guideline-concordant cancer SCP. The Commission on Cancer (CoC) quality 
program for survivorship care initially required that at least 75% of eligible 
patients receive a formal survivorship care plan document. Yet, cancer care 
providers found this standard difficult to achieve, which is illustrated by the 
subsequent change in the survivorship care standard to providing care plan 
documents to 50% of eligible participants in 2017.4,5 A publically available draft of 
the newly updated survivorship quality standard includes a recommendation for a 
formal care plan document, although has removed the requirement for a care 
plan document with an increased emphasis on the SCP delivery model and 
activities.6 Care plan documents in this new standard are considered one of the 
potential services offered as a component of meeting SCP requirements.6 
Recommended components of a comprehensive care plan document include: (1) 
a treatment summary and (2) outline of follow-up care needs including support 
for ongoing concerns and recommended healthy behaviors.3,7,8  

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
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While care plan documents were initially the focus of implementing SCP 
clinical guidelines, there is also an evidence gap in this approach.9,10 SCP 
guideline implementation focused on document/information delivery and 
demonstrated limited efficacy for improving patient health outcomes.9,11 In this 
document-focused model, when care plans were developed, they were 
infrequently delivered to survivors or other healthcare providers.12,13 Concerns for 
limited adoption of care plan documents included the perceived lack of evidence 
that documents improved outcomes.9 Evidence supports that care plan 
documents may benefit providers and health care systems, but the benefits to 
patients has remained unclear.14 Some document-focused SCP trials have been 
negative, with limited evidence of improved care coordination,15 and suggestions 
that care plans may even increase patient anxiety in patients experiencing more 
threatening illness.16 Recommended next steps for SCP research include 
enhancing information technology support for developing and optimizing the use 
of care plan documents,17 viewing SCP as an opportunity to facilitate patient 
engagement and support of self-management (e.g., health behaviors), and 
assessing care plans using hybrid implementation-effectiveness studies that 
consider context.1,9,11,17–20 
Recent evidence supports that cancer care plan documents are more 
efficacious when derived from shared decision making (e.g., patient-centered or 
preference-sensitive) versus provider-driven processes.1 A particularly strong 
SCP study that resulted in improved self-reported health outcomes (i.e., 
improvements in social, emotional, and physical role functioning, self-reported 
health, bodily pain) included one intervention session with a mental health 
professional focused on creating a patient-owned care plan through the process 
of goal setting, action planning, and other motivational interviewing techniques to 
engage survivors in self-managment.1 Another similar one in-person or telephone 
session with an advanced practice nurse that included goal setting and regular 
assessments of progress to foster survivors’ confidence in their ability to perform 
self-management showed preliminary support for improving patient-reported 
health outcomes (e.g., depression, anxiety, self-efficacy, physical functioning, 
role limitations, pain, general health, quality of life).2 Both of these SCP studies 
were based on the Chronic Care Model (CCM) in the context of transitioning from 
acute active cancer treatment to survivorship chronic condition management.1,2 
Limitations of these studies were that the delivery model did not include follow-up 
contact, which is typically part of the CCM.1 
The CCM posits that self-management support is a key component of a 
health system that delivers high-quality chronic illness care.21 Self-management 
support includes collaborating with patients to ensure they have the information 
and skills they need to be actively engaged in the process of their care and leads 
to improved health outcomes.21 An eHealth enhanced version of the CCM 
proposes that electronic tools can support productive patient-provider 
interactions and improve health outcomes.22 Self-determination Theory23 
provides more in depth guidance for the self-management support component of 
the CCM needed to result in the activated patient and productive interactions. 

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
Protocol version date 09/15/21 
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Self-determination Theory emphasizes that supporting patients’ partnership in 
healthcare decisions will enhance patients’ autonomous engagement in their 
care and ultimately lead to more sustainable improvement in health outcomes.24 
Patient-driven goals are more likely to be achieved than goals that are 
extrinsically motivated.25 One method for supporting patients’ engagement in 
their care and to support shared decision making is to use a patient-centered 
communication style and behavioral change strategies (i.e., self-management 
coaching).23 The CCM and Self-determination Theory fit within a comprehensive 
conceptual framework for implementing and assessing survivorship care 
planning that will be integrated with Proctor’s implementation outcomes 
framework.2,20,26 
The proposed SCP implementation program (SHARE-S) builds upon the 
above described successful SCP studies based on the CCM model1,2 and aims 
to enhance SCP implementation through self-management coaching and 
supportive text messages to increase engagement with the care plan and  
support SCP goals. Completing the complex process of SCP within the context 
of single clinical visit presents challenges (time constraints; healthcare provider 
may have limited knowledge of effective shared goal-setting techniques; and 
patient’s ability and willingness to commit to goals within the same time 
context).27 As providers and patients have increasingly compressed time during 
an in-person clinical visit, several visioning reports, including Crossing the Quality 
Chasm28 call for transforming medicine from episodic, in-person care to the 
provision of continuous, coordinated care delivery. Using Technology-Facilitated 
Implementation Science concepts, we will offload some of the implementation 
effort of guideline-concordant cancer SCP from clinical teams, and at the same 
time give patients more time to carefully engage in and consider their healthcare 
goals. Adding more robust follow-up contact may further enhance and sustain 
positive results found in the previously effective SCP delivery model. Shaping 
knowledge about SCP, identity (valued self-standards), regulation (reduce 
negative emotion [mindfulness] - skill), goals and planning, feedback and 
monitoring, comparison of outcomes, and social support (emotional) are 
the behavioral change techniques29–31 that will be adopted as 
implementation strategies to (1) prepare patients to be active participants 
and (2) enhance survivors uptake and adherence to the SCP guidelines 
(self-management).32  
 
Preliminary Data 
Provider Identified Local Setting Quality Gap. WFBCCC recently opened a 
Survivorship Clinic in Winston-Salem directed by Dr. Stacy Wentworth (Co-
Investigator) in June of 2019. The WFBCCC Survivorship Clinic has seen 
approximately 61 new cancer survivors from July – December 2019 
(approximately 10 per month). It is a high priority for WFBCCC to follow the CoC 
quality standard.6 Quality standard requirements are evaluated annually by 
reporting: (1) the estimated number of patients impacted by each of the chosen 
services; (2) the cancer sites impacted by each of the chosen services; and (3) 

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Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
Protocol version date 09/15/21 
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resources/processes utilized to enhance each of the chosen services.6 The 
updated CoC quality standard also includes a designated director of the 
survivorship care program, an identified team responsible for development of 
survivorship care delivery models and activities, and a survivorship program that 
addresses needs of cancer survivors.6 Dr. Wentworth has identified a local need 
such that 64% of the166 survivorship clinic patients seen in the past year who 
completed feedback surveys would also be interested in seeing a "counselor." 
The flyer for the Cancer Survivorship Clinic also lists “lifestyle” coaching as a 
component of the existing clinic visit with an advanced practice practitioner, a 
service, which Dr. Wentworth believes has room for improvement. Although 
different terms have been used, we will adopt the term “health” coaching as a 
more colloquial term for self-management coaching specific to the health context 
as the term we use to present this intervention to participants. Health coaching is 
an emerging field such that the American Medical Association Current 
Procedural Terminology (CPT) panel launched a relevant new level 3 CPT© for 
health coaching33 and using another term could lead to confusion if implemented 
more broadly. Therefore, providing coach and texting support in the proposed 
study may fill the unspecified gap identified by participants who would like 
additional counseling support and enhance (not replace) the intention of the clinic 
visit to provide coaching. Dr. Wentworth is thus interested in piloting the 
proposed enhanced survivorship visit that will pilot use of health coaching and 
supportive text messages . We will design this study so it will support the CoC 
quality standard requirement to provide an in-depth evaluation/review of this new 
service that aims to address survivors’ identified needs. Dr. Wentworth also 
directs SCP at WFBCCC Hayworth Cancer Center and is interested in extending 
evaluation of the enhanced survivorship visit to include this site. 
Patient Stakeholder Feedback (PI: Dr. Sohl). Our team has experience 
recruiting and implementing a one-session self-management intervention with 
colorectal cancer survivors through our pilot study entitled, Use of Systems 
Support Mapping to Guide Patient-Driven Self-Management in Rural and Urban 
Cancer Survivors in the same two clinics. We recruited 24 colorectal cancer 
survivors (36% of the 66 potentially eligible participants approached agreed to 
participate). Preliminary analyses revealed that a majority of participants (58.8%) 
indicated in a follow-up survey that they would find it helpful to meet with 
someone to discuss their goals monthly and preferred discussing these goals by 
telephone. Self-determination Theory guided the intervention and assessments 
selected in this study. Goals that emerged after holistically considering how to 
prioritize self-management within one’s life context included topics such as 
engaging in physical activity (walking, swimming), eating wisely, scheduling 
follow up care, finding quiet time (to pray, read, meditate), enhancing social 
connections (friends, family) and other personal development (e.g., cognitive, 
financial).  
Technology-assisted implementation experience (PI: Dr. Houston). We 
have experience with technology-assisted implementation to enhance 
engagement between clinical teams and patients. In a prior NCI trial, we 

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
Protocol version date 09/15/21 
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randomized 174 community-based practices; half of the practices were provided 
brochures (paper-referrals) to encourage patient access to a web-assisted 
tobacco intervention (WATI); and the other half of practices received an 
implementation program to support use of an “e-referral” tool, an online portal 
where registered clinical teams could, with patient permission, enter the patient’s 
email. These patients who were then e-referred received up to 10 automated 
emails, encouraging patients to use the WATI.34 Each practice adapted the 
automated messages for their own clinical setting. During the trial, a total of 
4,789 smokers were referred. Eighty-one of the eighty-seven practices 
randomized to e-referral referred at least one smoker. Mean smokers referred 
per practice was not statistically different by group (eRefer (24.9 (SD 22.3)) vs. 
comparison (30.1 (SD 25.5), p = 0.15), suggesting that the additional step of e-
referring was not excessively burdensome, compared to the brochure. The e-
referral portal implementation program resulted in nearly triple the rate of patient 
engagement (31% of all smokers e-referred used the WATI versus 11% in the 
brochure arm, p < 0.001) among smokers who were not highly motivated to quit. 
34 
3.0 
Objectives 
 
Shared SCP is more likely to be adopted, adhered to, and monitored. Yet, 
shared planning is challenging to integrate into brief clinical visits. Considering 
this translational gap, we propose the SHARE-S Implementation Program pilot. 
SHARE-S uses a clinical team-initiated, technology-facilitated shared 
survivorship planning system, engaging patients before and/or after survivorship 
care planning visits using a centralized, automated “meta-composite” tool. We 
will conduct a single-arm pragmatic pilot study of SHARE-S implemented in 
clinical care. We will test the study protocols, implementation program, and 
complete mixed-methods data collection to guide future study planning. The 
primary goal of this study is to assess how successfully SHARE-S can be 
implemented in a clinical setting that already consistently provides survivorship 
care planning documents to improve guideline concordant survivorship care. We 
will also collect data on the feasibility of assessing the impact of SHARE-S on 
service outcomes and patient outcomes. We will further document our overall 
progress through the Stages of Implementation Completion (pilot of 
Implementation Stages.35 
3.1 
Primary Objective 
 
3.1.1. To evaluate how successfully SHARE-S can be implemented into      
clinical care as characterized by rates of enrollment. 
 
We hypothesize >30% of patients e-referred to SHARE-S will enroll.  
 

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
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Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
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3.2 
Secondary Objective 
 
3.2.1  To assess additional implementation outcomes that evaluate   
preliminary implementation success (i.e., further assessment of 
adoption, acceptability, appropriateness, further assessment of 
feasibility, and fidelity).  
 
3.2.2   To describe service outcome variability to inform future studies. 
We will assess service outcomes relevant to CoC requirements6 by 
reporting annual estimates for: (1) the estimated number of patients 
impacted by SHARE-S; (2) the cancer sites impacted by SHARE-S; 
and the (3) resources/processes utilized to enhance each of the 
chosen services if barriers were encountered. We will also assess 
safety and perceived patient-centeredness of care. 
 
3.2.3 To describe patient health outcome variability to inform future 
studies (i.e., social role, physical functioning, anxiety, depression, 
fatigue, sleep disturbance, pain, cancer-specific quality of life, 
health behaviors, patient autonomy, self-efficacy for managing 
cancer, engagement with the survivorship care plan document, and 
satisfaction with care).  
 
3.2.4 To evaluate the Implementation Program we will assess key Stages 
of Implementation Completion (SIC) milestones and processes for 
this pilot study of the Implementation Stage,35 measured at the 
clinic level.  
 
3.2.5 To qualitatively assess implementation barriers and facilitators 
using semi-structured interviews that will be audio-recorded. 
 
3.2.6 To examine how study results vary by cancer type. 
4.0 
Patient Selection 
 
We aim to enroll 40 participants over 16 months. All participants will be 
recruited from Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
survivorship programs. We will ask clinic staff to use an e-referral tool to notify 
our study team of patients with an upcoming or recently completed survivorship 
visit. The eRefer portal developed by the University of Massachusetts Center for 
Clinical and Translational Science Informatics Core is a recruitment tool that 
allows potential participants to verbally agree to provide their email and/or cell 
phone number and be sent only one email and/or text message with information 
about a research opportunity they are interested in. Clinical staff, the “Referrer” in 
the eRefer portal, enter his/her email address on the eRefer home page, select 

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
Protocol version date 09/15/21 
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the study name from the project list and enter the potential participant’s email 
address and/or cell phone number as preferred by the patient (for this study we 
will use cell phone number only). By providing their email address or cell phone 
number, the patients verbally agree to be sent the study invitation messages and 
contacted for recruitment. After the referral has been executed, the eRefer portal 
provides study staff with the participant’s contact information, allowing the study 
team to contact the participant.  
The study team will then communicate with eligible patients either in 
person or remotely (e.g., telephone, myWakeHealth, mail) regarding their interest 
in study participation. The study coordinator will provide study information and 
answer questions to determine willingness to participate. After making sure the 
patient clearly understands the study procedures and agrees to follow them, the 
consent will be signed remotely or in person. If signed remotely, patients will be 
asked to send the form back to us by a secure means (e.g., REDCap, mail). In 
the case that the patient is consented remotely, either a hard copy or email 
attachment of the informed consent document will be provided to the participant. 
We will compensate participants up to $100 based on level of assessment 
completion ($25 for each assessment, $25 for the interview). Study 
compensation will not be mentioned by the “Referrer”. 
4.1 
Inclusion Criteria 
 
4.1.1 Adults ≥18 years of age  
4.1.2 Documented or planned cancer survivorship visit 
4.1.3 Have a texting enabled telephone 
4.1.4 Cognitively able to complete study procedures as judged by the 
study team 
4.1.5 Able to understand, read and write English 
 
Children under the age of 18 with cancer will be excluded due to the 
potentially different self-management support intervention needs of this 
population that will likely include parental involvement. Results from this 
research may inform future studies in children with cancer under 18 who 
should be researched separately.  
4.2 
Exclusion Criteria 
   
 
 
 
 
4.2.1 Declined participation in the study 
 
4.3 
Inclusion of Women and minorities 
 
The target population for this study is adult men and women who 
have a documented or planned cancer survivorship visit. We are drawing 
directly from patients seen by the clinic and thus expect that women and 

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minorities will be represented as is consistent with the proportion seen in 
the past five years at the Wake Forest Baptist Comprehensive Cancer 
Center. For this pilot study, non-English speaking patients will be excluded 
because the intervention content (text messages, coach calls) will be in 
English. Pending results of the pilot, a future study to determine the 
efficacy of translating the intervention will be proposed. Referrals will be 
implemented within the clinical workflow and the intervention is designed 
reduce barriers to participation with the goal of reaching all patients.  
5.0 
Methods 
 
5.1 
Registration Procedures 
 
This protocol utilizes Reduced Review registration which means 
that eligibility and other review are not performed by the CRM registrar. 
  
5.2 
Study-Related Activities 
 
The SHARE-S workflow supports a survivorship visit. The clinic scheduler 
or other staff will initiate a brief discussion about the opportunity for an enhanced 
survivorship visit with patients who have a documented or planned upcoming 
visit. Then the clinic staff will enter an e-referral to an automated computer-
tailored health communication system that shifts parts of the discussion to the 
time before and/or after a clinic visit and document this referral in the electronic 
health record (Epic/Wake One). 
Overview of Study-Related Activities  
a Pre-study requirements listed in table must be completed within 60 days prior to registration. 
b SHARE-S = study intervention, must be completed within one-year of registration. 
c Follow-up visit to be completed the same day or within 30 days of the final intervention session. 
 
5.3 
Intervention Description 
 
 
Pre-Studya 
Baseline 
SHARE-Sb 
Follow-upc   
E-referral 
X 
 
 
 
Informed consent 
X 
 
 
 
Demographic/ Clinical Factors 
 
X 
 
 
Self-Reported Measures 
 
X 
 
X 
Intervention Adherence 
 
 
X 
 
Acceptability Ratings 
 
 
 
X 
Semi-structured Interview 
 
 
 
X 
Adverse event evaluation 
 
 
X 
X 

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The proposed SCP implementation program (SHARE-S) has three 
components (please see Figure 1). First, we will use an electronic referral (e-
referral) to enhance care coordination and communication among clinical teams 
and the patient/family. We developed this tool and demonstrated the ability to 
implement an e-referral in our preliminary studies (at the University of 
Massachusetts Medical School). The e-referral provider-level component of the 
implementation program supports adaptation such that multiple clinical team 
members can complete the process, and it can be completed using the mobile 
app, on a desktop (e.g., when scheduling a clinic visit), or even expandable into 
the community. To execute a referral, the referring clinician goes to 
www.erefer.umassmed.edu, selects the messaging program they are referring to, 
and, with patient verbal permission, enters their cell phone number, and clicks 
submit. The patient then gets a welcome message with information about what 
they are receiving, and the clinic/study’s designated staff receive a notification of 
patient engagement, along with the patient’s contact information. The e-referral 
and text messaging systems will not be branded to participants as coming from 
any specific Institution. Patients can cancel the service with each message sent. 
To facilitate implementation of SHARE-S, facilitators will train clinical teams in the 
use of the SHARE-S technology enhancements. Each clinic will be asked to 
identify two implementation coordinators (physicians, nurses, or other staff). 
These two implementation coordinators act as points of contact and clinic 
champions. They will be trained in the e-referral tool and train-the trainer 
guidance, so they can act as an internal facilitator, engaging the rest of the 
practice and encouraging adoption. Training includes experiential learning 
(hands-on demonstrations of the eRefer tool, including initial registration; practice 
e-referring a “test” patient; and discussing what the patient will receive after 
eReferral) and materials that will support this initial conversation. As reminders, a 
series of motivational booster emails will be sent to clinic staff during the 6-week 
initiation period. The emails will be sent by the study team from the Wake Forest 
internal email system. For ongoing facilitation, our external facilitator will 
complete a total of four proactive booster facilitation calls (approximately 10-20 
minutes) assessing perceived barriers, strategizing solutions, and reinforcing 
success. Note that we found that registration in e-refer was a barrier for patients 
and providers, and we now have a method to remove this barrier. For SHARE-S, 
if a patient agrees to enroll, then they are automatically registered with the 
system and begin to receive the messages. This new eRefer process is 
adaptable, and we will monitor adaptations. Each clinic will be allowed to 
consider how to best integrate the referrals into their workflow, allowing for 
adaptation in implementation (who completes the referral, when in the workflow 
to bring up referral, etc.). 
 
 
 
 

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Second, we will support patient engagement with SCP guidelines7 
through self-management/health coaching. The first coaching 
call/videoconference will be 60 minutes and two subsequent coaching 
calls/videoconferences will be 30 minutes each. These sessions will be digitally 
recorded to review for treatment fidelity. Recordings will be made on a 
handheld device and saved to a Wake Forest server in a folder only accessible 
by the study team. Coaches will engage patients in a similar behavior change 
techniques described in the above mentioned exemplar one-session 
survivorship care planning intervention and other interventions that have 
informed recommendations included in survivorship clinical guidelines (i.e., 
goals and planning, feedback and monitoring, motivational interviewing).1,7  
Coaches will emphasize supporting the autonomy of the patient in facilitating 
behavior change consistent with the principles of behavior changed outlined by 
Self-determination Theory.23 Other theoretical models for health behavior 
change generally choose the behavior of study and do not focus on peoples’ 
motivation to engage in a particular behavior within their broader life context of 
other behaviors and how they contribute to broader goals.36 In this study, 
coaches will support participants in selecting personalized health goals to be 
consistent with our conceptual framework that is grounded in promoting patient 
choice. This approach was successfully implemented in another telephone 
lifestyle coaching study that provided participants with a range of topics for 
health goals that we adapted for use in this study: (1) Eat Wisely; (2) Be 
Physically Active; (3) Be Tobacco Free/Limit Alcohol; (4) Strengthen Social 
Connections; (5) Restore (e.g., manage Stress); (6) Get adequate Rest; (7) 
Engage in preventive Care; (8) Other Personal Development (e.g., spiritual, 
work, finance).37 Goals that emerged when considering life context from cancer 
survivors in our preliminary data informed adapted and added topics. The 
health coaching model adopted in this study includes training in mindfulness to 
enhance autonomy support.23 
Third, the patient receives a set of automated, tailored text messages 
(daily for 3 weeks after the first and second coach calls for a total of 6 weeks). 
SHARE-S offloads some communication about SCP, and enhances patient 
understanding and activation through the concept of spaced education,38–40 
providing small pieces of information over time, and through brief assessments 
that can guide shared decision-making. Although evidence for these approaches 
exist, they have rarely been used in the context of cancer, and have not been 
applied to SCP. We adapted this text messaging intervention content with 
stakeholder input for use with cancer survivors. The system can send messages 
with a request for patient response (a two-way message) and store that 
information as an additional tailoring variable and as patient-generated data to be 
reviewed by the clinical teams. Messages can sent by text and will be based on 
the key components of SCP. We will also mail participants a packet of materials 
summarizing SCP and each of the topics introduced in coaching and text 
messages. 
6.0 
Outcome Measures 
 

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We will collect patient-reported data either remotely or in person at 
baseline (before the first coaching call) and follow-up (after the last coaching 
call). 
 
6.1 
Primary Outcome 
 
6.1.1. Feasibility as defined by the # participants enrolled/those e-referred. 
6.2 
Secondary Outcomes 
 
 6.2.1. Other implementation outcomes  
6.2.1.1. Adoption (e.g., #e-referred patients e-referred/those 
possible [based on chart review]) 
6.2.1.2. Acceptability (e.g., Acceptability of Intervention Measure41, 
qualitative feedback from cancer survivors) 
6.2.1.3. Appropriateness (e.g., Intervention Appropriateness 
Measure41) 
6.2.1.4. Other indicators of feasibility (e.g., number of participants 
enrolled per month, Feasibility of Intervention Measure,41 
adherence rates, retention rates) 
6.2.1.5. Fidelity (e.g., patient adherence to text responses, 
adherence to coaching sessions, length of coaching sessions, 
observational checklist completed for a subset of coaching 
sessions) 
 
6.2.2 Service outcomes 
 
 
6.2.2.1. Number of patients enrolled  
6.2.2.2. Cancer types 
6.2.2.3. Qualitative feedback on resources/processes utilized to 
enhance each of the chosen services  
6.2.2.4. Adverse events related to the intervention will be described 
6.2.2.5. Patient-reported measure of patient-centered 
communication42 and relatedness completed only at follow-up 
[HEAL Patient-Provider Connection]43 
 
6.2.3 Patient health outcomes (Self-reported) 
 
6.2.3.1.1 
Social role, physical functioning, anxiety, depression, 
fatigue, sleep disturbance, pain [PROMIS Profile 29; 
also used in clinical practice]44. We will also assess the 
feasibility of pulling these data from the electronic 
health record. 

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6.2.3.1.2 
General health [one-item assessing perceived 
health].45 
6.2.3.1.3 
Cancer-specific quality of life [Cancer-specific 
subscale of the QLACS]46,47 
6.2.3.1.4 
Health behaviors [tobacco use, alcohol use,48 physical 
activity, nutrition, stress reduction] 
6.2.3.1.5 
Patient autonomy [Index of Autonomous Functioning]49 
Self-efficacy for managing cancer [Self-efficacy to 
Manage Chronic Disease Scale]50,51 Mindfulness52 
6.2.3.1.6 
Engagement with the survivorship care plan document 
(Self-reported reference to the care plan since it was 
given to them) 
6.2.3.1.7 
Satisfaction with care 
 
6.2.4 Implementation Program 
 
6.2.4.1 
Time from opening the study to first patient e-referred, time 
to 10th patient e-referred 
6.2.4.2 
When the survivor was e-referred (indicating whether it was 
when scheduling an appointment or required review of 
upcoming appointments). We will use a combination of field 
notes, electronic medical record notes, and direct 
observation to measures these milestones. 
 
6.2.5 We will also adopt mixed-methods to assess select implementation 
outcomes as guided by the Consolidated Framework for 
Implementation Research (CFIR).53 We chose to incorporate CFIR 
because it will facilitate assessment of potential barriers and 
facilitators at multiple levels to help us prepare for implementing 
SHARE-S more widely.  
 
6.2.6 Clinical factors (cancer type, time since diagnosis, prior treatments, 
comorbidities) abstracted from medical charts or self-reported.  
 
We will also collect demographic characteristics for descriptive 
purposes (age, sex, rural-urban residence [classified by the Federal 
Office of Rural Health Policy definition of rural],54 race/ethnicity, 
marital status, education level, health literacy).55  
7.0 
Analytic Plan 
7.1 
Sample Size and Power 
 

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This pilot study has an accrual goal of 40 cancer survivors. The 
primary objective is to evaluate the feasibility of implementing SHARE-S 
into clinical care, where feasibility is defined based on the rate of enrollment. 
Assuming a negative binomial distribution and true enrollment rate of 30%, 
the probability that we would have to approach 164 or more people to 
recruit 40 is <0.05. Therefore, if we approach ≥164 participants to enroll 
40, it is unlikely the true probability is above 30%, and we will conclude the 
study may not be feasible. Assuming we are able to enroll 40 survivors, 
with this sample size we will be able to estimate rates of interest within +/- 
16% using exact 95% binomial confidence intervals. A sample size of 40 
will also allow for reasonable estimates of SDs to be used to plan future 
studies. 
The number of participants interviewed (12-24) will be determined 
when data saturation is reached. As is conventional for thematic analysis, 
we will conduct interviews until we think there is enough qualitative data to 
address issues related to the acceptability of study procedures.56 The 
study team’s experience leads us to believe that 12-15 interviews from 
cancer survivors will be sufficient to achieve this objective. Our analyses 
of differences between cancer type will be for exploratory purposes and 
therefore data saturation using those variables is not the goal. If 
unexpected information emerges and our timeline allows, we will consider 
amending the protocol to recruit additional participants. 
7.2 
Data Analyses  
 
 
This study will provide quantitative data on implementation 
outcomes, service outcomes, patient health outcomes, implementation 
program information, and qualitative feedback on barriers and facilitators 
to guide future study planning. We will calculate 95% confidence intervals 
for each of the measures to determine the range of estimates that are 
consistent with our data. We will track the number of patients seen in the 
Survivorship Clinic, the number e-referred, and the percent who agree to 
enroll in SHARE-S. For those not enrolled, reasons will be summarized. 
The proportion of participants and corresponding exact 95% CI for 
participants who participated in SHARE-S and those who completed all 
assessments will be computed; we will also calculate the frequency of any 
adverse events and percent of participants who complete the follow-up 
visit to assess retention. We will use one-sample tests of binomial 
proportions to compare the recruitment rate to the hypothesized value of 
30%. In exploratory analyses, we will compare participants who enroll 
versus decline, are non-adherent or who drop out by demographic 
characteristics and baseline scores of the measures (when applicable) 
using fisher’s exact tests or Wilcoxon rank sum tests as appropriate. We 
will also investigate any differences in these analyses by cancer type. 

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Baseline analyses will include descriptive statistics of quantitative 
data on implementation outcomes, service outcomes, patient health 
outcomes, and background characteristics (i.e., clinical, demographic). 
The distributions of continuous variables will be examined to determine 
the presence of outliers and whether transformations are necessary for 
analysis. The primary goal of the statistical analysis of these measures will 
be to estimate standard deviations (SD) for use in future studies. 
Additional analyses will include fitting mixed ANCOVA models (adjustment 
for baseline) to model the trajectory of patient health outcomes by time 
and group accounting for the repeated measures on a subject. The 
purpose of all of these models will be to obtain estimates of the SD of 
change adjusted for covariates of interest and the within-person 
correlation of the repeated measures, not to perform formal hypothesis 
testing. We will consider the different recall time frame for the quality of life 
measures when interpreting the results. In exploratory models we will 
examine the impact of adherence to SHARE-S on changes in the 
measures, subgroup analysis by cancer type, and we will examine the role 
of patient autonomy and self-efficacy as potential mechanisms. The 
purpose of these analyses will be to estimate SD and within-person 
correlation by subgroup and with adjustment for mechanisms; no formal 
hypothesis testing will be done. 
 
Interview transcripts will be coded independently by the QPRO 
shared resource staff at WFBH. Twenty-five percent of the transcripts will 
be coded by two separate coders to ensure consistency of code 
application. Unresolved discrepancies reconciled by a third person. Using 
thematic analysis, the coded text will be iteratively reviewed and 
interpreted.56 The qualitative and quantitative analyses will be evaluated in 
a mixed-methods framework for consistency and discrepancies to refine 
the protocol for future studies. In particular, we will analyze the feasibility, 
acceptability and appropriateness data using a mixed-methods since 
these measures have not been validated in a similar sample. For example, 
if the qualitative interviews indicate that a particular subgroup of patients 
(e.g., by cancer type) perceive greater benefit from SHARE-S, then we will 
perform exploratory subgroup analysis of the quantitative data. 
7.3 
Accrual Rate 
 
The WFBCCC Survivorship Clinic has seen approximately 61 new 
cancer survivors (multiple cancer types) from July – December 2019 
(approximately 10 per month). In addition, our team has experience 
recruiting and implementing a one-session self-management intervention 
with colorectal cancer survivors. We recruited 24 exclusively colorectal 
cancer survivors (36% of the 66 potentially eligible participants 
approached agreed to participate). Therefore, we conservatively expect to 

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enroll 2-3 participants per month over 16 months to reach our accrual goal 
of 40. 
7.4 
Length of Study 
 
We estimate that we will complete study enrollment in 16 months, 
follow-up in 18 months, and analyses in 24 months.   
8.0 
Data Management 
 
Informed consent document 
EPIC 
E-referral documented, decline reasons 
EPIC 
Protocol Registration Form 
WISER/OnCore 
Demographic Factors 
WISER/OnCore 
Patient-reported Measures 
REDCap 
Intervention Fidelity Form 
REDCap 
Chart review: Clinical Factors 
REDCap 
Intervention Materials 
Files on a local Secure Server in a folder 
accessible only by the study team 
Process measures 
Files on a local Secure Server in a folder 
accessible only by the study team 
Patient adherence and text responses 
Files on a Secure Server (tech system 
hosted at University of Massachusetts) 
Qualitative feedback 
Files on a local Secure Server in a folder 
accessible only by the study team 
Adverse Events Log 
WISER/OnCore 
9.0 
Confidentiality and Privacy 
 
Confidentiality will be protected by collecting only information needed to 
assess study outcomes, minimizing to the fullest extent possible the collection of 
any information that could directly identify subjects, and maintaining all study 
information in a secure manner. To help ensure subject privacy and 
confidentiality, only a unique study identifier will appear on the data collection 
form. Any collected patient identifying information corresponding to the unique 
study identifier will be maintained on a linkage file, store separately from the 
data. The linkage file will be kept secure, with access limited to designated study 
personnel. Following data collection, subject identifying information will be 
destroyed consistent with data validation and study design, producing an 
anonymous analytical data set. Data access will be limited to study staff. Data 
and records will be kept locked and secured, with any computer data password 
protected. No reference to any individual participant will appear in reports, 
presentations, or publications that may arise from the study. 

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Data collected in the eRefer portal (patient contact information) will be 
stored by the University of Massachusetts in a regulated environment until 
completion of the project or upon the request of the potential participant. The 
regulated environment provides applications to a secure network for collecting 
and storing confidential data. The regulated environment has been securely 
configured to allow application access via the secure socket layer (HTTPS) 
protocol. The regulated environment is secured using hardware and software 
firewalls, along with access restrictions to provide the needed security protocols 
for the regulatory and Federal standards required.  Access is restricted through a 
Virtual Private Network, a secure RSA token, and only restricted personnel are 
allowed access to the regulated environment. The software program will use a 
secure Application Programmable Interface to send and receive the text 
messages. These text messages will be sent from toll-free number (1-844-276-
4493). 
The texting service, also developed by the University of Massachusetts, will 
be responsible for sending the texts and receiving the text responses. The 
software program will use a secure Application Programmable Interface to the 
service to send and receive the texts. To minimize risks, text messages will not 
contain any personal health information. The software program will read the 
texting service servers to extract the data and enter the regulated environment. 
As soon as this is complete, the program will then delete the data from the 
texting service servers. The texting service does not store the phone numbers. It 
will only use the phone number to send and receive messages. During the 
informed consent process, participants will be informed of this potential risk to 
confidentiality through their sending and receiving text messages. 
All data will be stored in a HIPAA compliant regulated environment and 
access will be only through a secure VPN network. All patient related identifiers 
are encrypted in the database. The regulated environment provides applications 
a secure network for collecting and storing confidential data. The regulated 
environment has been securely configured to allow application access via the 
secure socket layer (HTTPS) protocol. The regulated environment is secured 
using hardware and software firewalls, along with access restrictions to provide 
the needed security protocols for the regulatory and Federal standards required.  
Access is restricted through a Virtual Private Network, a secure RSA token, and 
only restricted personnel are allowed access to the regulated environment. 
10.0 Data Safety and Monitoring 
 
The principal investigator will be responsible for the overall monitoring of 
the data and safety of study participants. The principal investigator will be 
assisted by other members of the study staff. 

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11.0 Reporting of Unanticipated Problems, Adverse Events or 
Deviations 
 
Any unanticipated problems, serious and unexpected adverse events, 
deviations or protocol changes will be promptly reported by the principal 
investigator or designated member of the research team to the IRB and sponsor 
or appropriate government agency if appropriate. 
 
12.0 References 
 
1 Kvale EA, Huang C-HS, Meneses KM, Demark-Wahnefried W, Bae S, Azuero CB, et 
al. Patient-centered support in the survivorship care transition: Outcomes from the 
Patient-Owned Survivorship Care Plan Intervention. Cancer 2016;122:3232–42. 
https://doi.org/10.1002/cncr.30136. 
2 Reb A, Ruel N, Fakih M, Lai L, Salgia R, Ferrell B, et al. Empowering survivors after 
colorectal and lung cancer treatment: Pilot study of a Self-Management Survivorship 
Care Planning intervention. Eur J Oncol Nurs Off J Eur Oncol Nurs Soc 2017;29:125–
34. https://doi.org/10.1016/j.ejon.2017.06.003. 
3 National Research Council. From Cancer Patient to Cancer Survivor: Lost in 
Transition. Washington, D.C.: The National Academies Press; 2005. 
4 American College of Surgeons. Important information regarding CoC Survivorship 
Care Plan Standard. n.d. 
5 Birken SA, Raskin S, Zhang Y, Lane G, Zizzi A, Pratt-Chapman M. Survivorship Care 
Plan Implementation in US Cancer Programs: a National Survey of Cancer Care 
Providers. J Cancer Educ 2018. https://doi.org/10.1007/s13187-018-1374-0. 
6 Commission on Cancer. Draft CoC Revised Standards. 2019. URL: 
https://www.facs.org/~/media/files/quality%20programs/cancer/coc/draft_coc_revised
_standards_may2019.ashx (Accessed 2 January 2020). 
7 National Comprehensive Cancer Network (NCCN). NCCN Guidelines: Survivorship. 
2019. 
8 Mayer DK, Nekhlyudov L, Snyder CF, Merrill JK, Wollins DS, Shulman LN. American 
Society of Clinical Oncology clinical expert statement on cancer survivorship care 
planning. J Oncol Pract 2014;10:345–51. https://doi.org/10.1200/JOP.2014.001321. 
9 Jacobsen PB, DeRosa AP, Henderson TO, Mayer DK, Moskowitz CS, Paskett ED, et 
al. Systematic Review of the Impact of Cancer Survivorship Care Plans on Health 
Outcomes and Health Care Delivery. J Clin Oncol Off J Am Soc Clin Oncol 
2018;36:2088–100. https://doi.org/10.1200/JCO.2018.77.7482. 
10 
Birken SA, Urquhart R, Munoz-Plaza C, Zizzi AR, Haines E, Stover A, et al. 
Survivorship care plans: are randomized controlled trials assessing outcomes that 
are relevant to stakeholders? J Cancer Surviv Res Pract 2018;12:495–508. 
https://doi.org/10.1007/s11764-018-0688-6. 
11 
van de Poll-Franse LV, Nicolaije KAH, Ezendam NPM. The impact of cancer 
survivorship care plans on patient and health care provider outcomes: a current 
perspective. Acta Oncol Stockh Swed 2017;56:134–8. 
https://doi.org/10.1080/0284186X.2016.1266080. 

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
Protocol version date 09/15/21 
Page 21 of 26 
 
12 
Birken SA, Deal AM, Mayer DK, Weiner BJ. Determinants of survivorship care 
plan use in US cancer programs. J Cancer Educ Off J Am Assoc Cancer Educ 
2014;29:720–7. https://doi.org/10.1007/s13187-014-0645-7. 
13 
Birken SA, Clary AS, Bernstein S, Bolton J, Tardif-Douglin M, Mayer DK, et al. 
Strategies for Successful Survivorship Care Plan Implementation: Results From a 
Qualitative Study. J Oncol Pract 2018;14:e462–83. 
https://doi.org/10.1200/JOP.17.00054. 
14 
LaGrandeur W, Armin J, Howe CL, Ali-Akbarian L. Survivorship care plan 
outcomes for primary care physicians, cancer survivors, and systems: a scoping 
review. J Cancer Surviv Res Pract 2018;12:334–47. https://doi.org/10.1007/s11764-
017-0673-5. 
15 
Boekhout AH, Maunsell E, Pond GR, Julian JA, Coyle D, Levine MN, et al. A 
survivorship care plan for breast cancer survivors: extended results of a randomized 
clinical trial. J Cancer Surviv Res Pract 2015;9:683–91. 
https://doi.org/10.1007/s11764-015-0443-1. 
16 
de Rooij BH, Ezendam NPM, Nicolaije KAH, Lodder P, Vos MC, Pijnenborg JMA, 
et al. Survivorship care plans have a negative impact on long-term quality of life and 
anxiety through more threatening illness perceptions in gynecological cancer 
patients: the ROGY care trial. Qual Life Res Int J Qual Life Asp Treat Care Rehabil 
2018;27:1533–44. https://doi.org/10.1007/s11136-018-1825-4. 
17 
Kline RM, Arora NK, Bradley CJ, Brauer ER, Graves DL, Lunsford NB, et al. 
Long-Term Survivorship Care After Cancer Treatment - Summary of a 2017 National 
Cancer Policy Forum Workshop. JNCI J Natl Cancer Inst 2018;110:1300–10. 
https://doi.org/10.1093/jnci/djy176. 
18 
Keesing S, McNamara B, Rosenwax L. Cancer survivors’ experiences of using 
survivorship care plans: a systematic review of qualitative studies. J Cancer Surviv 
Res Pract 2015;9:260–8. https://doi.org/10.1007/s11764-014-0407-x. 
19 
Selove R, Birken SA, Skolarus TA, Hahn EE, Sales A, Proctor EK. Using 
implementation science to examine the impact of cancer survivorship care plans. J 
Clin Oncol 2016;34:3834–7. https://doi.org/10.1200/JCO.2016.67.8060. 
20 
Parry C, Kent EE, Forsythe LP, Alfano CM, Rowland JH. Can’t see the forest for 
the care plan: a call to revisit the context of care planning. J Clin Oncol Off J Am Soc 
Clin Oncol 2013;31:2651–3. https://doi.org/10.1200/JCO.2012.48.4618. 
21 
Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients 
with chronic illness. JAMA 2002;288:1775–9. 
22 
Gee PM, Greenwood DA, Paterniti DA, Ward D, Miller LMS. The eHealth 
Enhanced Chronic Care Model: A theory derivation approach. J Med Internet Res 
2015;17:e86. https://doi.org/10.2196/jmir.4067. 
23 
Sohl SJ, Birdee G, Elam R. Complementary tools to empower and sustain 
behavior change: Motivational interviewing and mindfulness. Am J Lifestyle Med 
2016;10:429–36. https://doi.org/10.1177/1559827615571524. 
24 
Ng JYY, Ntoumanis N, Thøgersen-Ntoumani C, Deci EL, Ryan RM, Duda JL, et 
al. Self-Determination Theory Applied to Health Contexts A Meta-Analysis. Perspect 
Psychol Sci 2012;7:325–40. https://doi.org/10.1177/1745691612447309. 

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
Protocol version date 09/15/21 
Page 22 of 26 
 
25 
Mann T, de Ridder D, Fujita K. Self-regulation of health behavior: Social 
psychological approaches to goal setting and goal striving. Health Psychol 
2013;32:487–98. http://dx.doi.org/10.1037/a0028533. 
26 
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al. 
Outcomes for implementation research: conceptual distinctions, measurement 
challenges, and research agenda. Adm Policy Ment Health 2011;38:65–76. 
https://doi.org/10.1007/s10488-010-0319-7. 
27 
Birken SA, Mayer DK, Weiner BJ. Survivorship care plans: prevalence and 
barriers to use. J Cancer Educ 2013;28:290–6. https://doi.org/10.1007/s13187-013-
0469-x. 
28 
Committee on Quality of Health Care in America, Institute of Medicine. Crossing 
the Quality Chasm: A New Health System for the 21st Century. Washington, D.C.: 
National Academy Press; n.d. 
29 
Quintiliani LM, Foster M, Oshry LJ. Preferences of mHealth app features for 
weight management among breast cancer survivors from underserved populations. 
Psychooncology 2019;28:2101–4. https://doi.org/10.1002/pon.5190. 
30 
Michie S, Wood CE, Johnston M, Abraham C, Francis JJ, Hardeman W. 
Behaviour change techniques: the development and evaluation of a taxonomic 
method for reporting and describing behaviour change interventions (a suite of five 
studies involving consensus methods, randomised controlled trials and analysis of 
qualitative data). Health Technol Assess Winch Engl 2015;19:1–188. 
https://doi.org/10.3310/hta19990. 
31 
Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A, et al. Making 
psychological theory useful for implementing evidence based practice: a consensus 
approach. Qual Saf Health Care 2005;14:26–33. 
https://doi.org/10.1136/qshc.2004.011155. 
32 
Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, et 
al. A refined compilation of implementation strategies: results from the Expert 
Recommendations for Implementing Change (ERIC) project. Implement Sci 
2015;10:21. https://doi.org/10.1186/s13012-015-0209-1. 
33 
The National Board for Health and Wellness Coaching (NBHWC). American 
Medical Association approves new category III CPT codes for coaching. 24-7 Press 
Release 2019. 
34 
Houston TK, Sadasivam RS, Allison JJ, Ash AS, Ray MN, English TM, et al. 
Evaluating the QUIT-PRIMO clinical practice ePortal to increase smoker engagement 
with online cessation interventions: a national hybrid type 2 implementation study. 
Implement Sci IS 2015;10:. https://doi.org/10.1186/s13012-015-0336-8. 
35 
Chamberlain P, Brown CH, Saldana L. Observational measure of implementation 
progress in community based settings: The Stages of implementation completion 
(SIC). Implement Sci 2011;6:116. https://doi.org/10.1186/1748-5908-6-116. 
36 
Ajzen I, Kruglanski AW. Reasoned action in the service of goal pursuit. Psychol 
Rev 2019;126:774–86. https://doi.org/10.1037/rev0000155. 
37 
Damschroder LJ, Reardon CM, Sperber N, Robinson CH, Fickel JJ, Oddone EZ. 
Implementation evaluation of the Telephone Lifestyle Coaching (TLC) program: 

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
Protocol version date 09/15/21 
Page 23 of 26 
 
organizational factors associated with successful implementation. Transl Behav Med 
2017;7:233–41. https://doi.org/10.1007/s13142-016-0424-6. 
38 
Kerfoot BP. Learning benefits of on-line spaced education persist for 2 years. J 
Urol 2009;181:2671–3. https://doi.org/10.1016/j.juro.2009.02.024. 
39 
Kerfoot BP, Lawler EV, Sokolovskaya G, Gagnon D, Conlin PR. Durable 
improvements in prostate cancer screening from online spaced education a 
randomized controlled trial. Am J Prev Med 2010;39:472–8. 
https://doi.org/10.1016/j.amepre.2010.07.016. 
40 
Kerfoot BP, Kearney MC, Connelly D, Ritchey ML. Interactive spaced education 
to assess and improve knowledge of clinical practice guidelines: a randomized 
controlled trial. Ann Surg 2009;249:744–9. 
https://doi.org/10.1097/SLA.0b013e31819f6db8. 
41 
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. 
Psychometric assessment of three newly developed implementation outcome 
measures. Implement Sci 2017;12:108. https://doi.org/10.1186/s13012-017-0635-3. 
42 
Blanch-Hartigan D, Chawla N, Moser RP, Finney Rutten LJ, Hesse BW, Arora 
NK. Trends in cancer survivors’ experience of patient-centered communication: 
results from the Health Information National Trends Survey (HINTS). J Cancer Surviv 
Res Pract 2016;10:1067–77. https://doi.org/10.1007/s11764-016-0550-7. 
43 
Greco CM, Yu L, Johnston KL, Dodds NE, Morone NE, Glick RM, et al. 
Measuring nonspecific factors in treatment: item banks that assess the healthcare 
experience and attitudes from the patient’s perspective. Qual Life Res 2016;25:1625–
34. https://doi.org/10.1007/s11136-015-1178-1. 
44 
Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, et al. The Patient-
Reported Outcomes Measurement Information System (PROMIS) developed and 
tested its first wave of adult self-reported health outcome item banks: 2005-2008. J 
Clin Epidemiol 2010;63:1179–94. https://doi.org/10.1016/j.jclinepi.2010.04.011. 
45 
The Mos Short-Form General Health Survey: Single Item vs Multiple Measures of 
Health-Related Quality of Life: Some Nuances - G. I. J. M. Kempen, 1992. n.d. URL: 
https://journals.sagepub.com/doi/abs/10.2466/pr0.1992.70.2.608 (Accessed 27 
February 2020). 
46 
Avis NE, Smith KW, McGraw S, Smith RG, Petronis VM, Carver CS. Assessing 
quality of life in adult cancer survivors (QLACS). Qual Life Res 2005;14:1007–23. 
47 
Sohl SJ, Levine B, Avis NE. Evaluation of the Quality of Life in Adult Cancer 
Survivors (QLACS) scale for early post-treatment breast cancer survivors. Qual Life 
Res Int J Qual Life Asp Treat Care Rehabil 2015;24:205–12. 
https://doi.org/10.1007/s11136-014-0749-x. 
48 
Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol 
consumption questions (AUDIT-C): an effective brief screening test for problem 
drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use 
Disorders Identification Test. Arch Intern Med 1998;158:1789–95. 
https://doi.org/10.1001/archinte.158.16.1789. 
49 
Weinstein N, Przybylski AK, Ryan RM. The index of autonomous functioning: 
Development of a scale of human autonomy. J Res Personal 2012;46:397–413. 
https://doi.org/10.1016/j.jrp.2012.03.007. 

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Survivorship 
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Protocol version date 09/15/21 
Page 24 of 26 
 
50 
Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic 
Disease Scale measures were validated using multiple studies. J Clin Epidemiol 
2014;67:1265–73. https://doi.org/10.1016/j.jclinepi.2014.06.009. 
51 
Moore SM, Schiffman R, Waldrop-Valverde D, Redeker NS, McCloskey DJ, Kim 
MT, et al. Recommendations of Common Data Elements to Advance the Science of 
Self-Management of Chronic Conditions. J Nurs Scholarsh Off Publ Sigma Theta Tau 
Int Honor Soc Nurs 2016;48:437–47. https://doi.org/10.1111/jnu.12233. 
52 
Brown KW, Ryan RM. The benefits of being present: Mindfulness and its role in 
psychological well-being. J Pers Soc Psychol 2003;84:822–48. 
http://dx.doi.org/10.1037/0022-3514.84.4.822. 
53 
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. 
Fostering implementation of health services research findings into practice: a 
consolidated framework for advancing implementation science. Implement Sci IS 
2009;4:50. https://doi.org/10.1186/1748-5908-4-50. 
54 
Health Resources and Services Administration. Defining Rural Population. 
Defining Rural Population. 2017. URL: https://www.hrsa.gov/rural-health/about-
us/definition/index.html (Accessed 4 June 2019). 
55 
Wallace LS, Rogers ES, Roskos SE, Holiday DB, Weiss BD. Brief report: 
screening items to identify patients with limited health literacy skills. J Gen Intern Med 
2006;21:874–7. https://doi.org/10.1111/j.1525-1497.2006.00532.x. 
56 
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 
2006;3:77–101. https://doi.org/10.1191/1478088706qp063oa. 
 

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
Protocol version date 9/15/21 
 
Page 25 of 26 
Appendix A – Subject Eligibility Checklist 
 
 
IRB Protocol No. 000064683 
WFBCCC 99420 
Study Title: SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Principal Investigator:  Stephanie Sohl, PhD 
 
Inclusion Criteria 
(as outlined in study protocol) 
Criteria 
is met 
Criteria 
is NOT 
met 
Source Used to Confirm * 
(Please document dates and lab 
results) 
Adults ≥18 years of age  
 
□ 
□ 
 
Documented or planned cancer 
survivorship visit 
 
□ 
□ 
 
Have a texting enabled telephone 
 
□ 
□ 
 
Cognitively able to complete study 
procedures as judged by the study team 
 
□ 
□ 
 
Able to understand, read and write 
English 
□ 
□ 
 
Exclusion Criteria 
(as outlined in study protocol) 
Criteria 
NOT 
present 
Criteria 
is 
present 
Source Used to Confirm * 
(Please document dates and lab 
results) 
Declined participation in the study 
□ 
□ 
 
 
This subject is      
 eligible / 
 ineligible   for participation in this study. 
 
ORIS Assigned PID: __________________ 
 
 
 
 
 
 
 
 
 
Signature of research professional confirming eligibility: _______________________ 
Date: _______________ 
 
* Examples of source documents include clinic note, pathology report, laboratory results, etc. When listing 
the source, specifically state which document in the medical record was used to assess eligibility. Also 
include the date on the document. Example: “Pathology report, 01/01/14” or “Clinic note, 01/01/14” 
 
 
 
 

SHARE-S Aim 3: Shared Healthcare Actions & Reflections Electronic systems in 
Survivorship 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99420 
Protocol version date 9/15/21 
 
Page 26 of 26 
Appendix B – Protocol Reduced Review Registration Form 
 
 
DEMOGRAPHICS 
Last Name: _____________________ 
First Name: ___________________________ 
MRN:          ___ ___ ___ ___ ___ ___ ___ ___ ZIPCODE: ___ ___ ___ ___ ___ 
  
 
 
 
*SEX:   
  Male      Female 
 
 
*Ethnicity (choose 
one):   
 Hispanic        Non-Hispanic 
 
*Race (choose all that 
apply): 
 WHITE        African American            
 ASIAN          PACIFIC ISLANDER                 
 NATIVE AMERICAN (Alaskan) 
*Diagnosis: ____________________________________________________________ 
DOB (mm/dd/yy): ___ ___ / ___ ___ / ___ ___ (include if no MRN is provided) 
 
Comprehensive Cancer Center requires that all registrations be sent to the CCCWFU Centralized Registrar 
the day the patient is consented; if this is not possible we require that all registration be communicated to the 
Centralized Registrar within 72 hours by the CRM registrar. 
 
**Reduced Review means eligibility and other review are not performed by CRM registrar. 
 
For questions, the Protocol Registrar can be contact by calling 336-713-6767 between 8:30 AM and 4:00 PM, 
Monday – Friday. 
 
Completed Eligibility Checklist and Protocol Registration Form must be hand delivered, faxed or e-mailed to 
the registrar at 336-713-6772 or registra@wakehealth.edu. 
 
*** if not using the full wakehealth.edu outlook client (full outlook, not web outlook) save this file and 
attach to an email to registra@wakehealth.edu. 
 
 
*MD Name (Last, First) : 
______________________, _________________________      
*Date of Consent: 
___ ___ / ___ ___ / ___ ___ 
 
Date of Registration: (if different than 
consent) 
___ ___ / ___ ___ / ___ ___ 
PID # (OnCore): 
___ ___ ___ ___ ___ ___ ___ ___ (to be completed by registrar)