Cancer Within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological Resilience Amidst Dual Health Threats
Phase: NA
Conditions: Cancer, Survivorship, Depression, Anxiety
Sponsor: Wake Forest University Health Sciences

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment 
Psychological Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
i of 36 
 
 
Principal Investigator: 
 
Katie Duckworth, PhD 
Internal Medicine / Hematology/Oncology 
 
 
 
 
Co-Investigator(s):  
 
Lisa Rainwater, PhD 
Cancer Patient Support Program  
 
 
 
Richard McQuellon, PhD 
Internal Medicine / Hematology/Oncology 
 
 
 
Aimee Tolbert, MA 
Psychologist 
Hematology and Oncology 
 
 
 
Stephanie Lichiello, MA 
Psychologist 
Hematology and Oncology 
 
 
 
Victoria O’Conner 
Student Intern 
Comprehensive Cancer Center 
  
 
 
Meredith Harrison, MA 
Wake Forest University 
 
 
 
 
Biostatistician: 
 
Greg Russell, MS 
Comprehensive Cancer Center of Wake Forest University 
Department of Biostatistics and Data Science 
 
 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment 
Psychological Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
ii of 36 
 
 
 
 
 
 
Study Coordinator: 
Camisha Johnson 
Clinical Studies Coordinator I  
 
 
 
 
Regulatory Contact: 
Emily Teal, MA 
Regulatory Specialist II  
 
 
 
 
Protocol Editor:                                Kathy Walker, BA 
Comprehensive Cancer Center of Wake Forest University 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participating Institution(s): Wake Forest Baptist Medical Center 
 
 
Version Date: 05/14/21 
Amended: 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment 
Psychological Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
iii of 36 
 
 
 
 
 
Confidential
Table of Contents 
SCHEMA ............................................................................................................................................................... 5 
1.0 
Introduction and Background ........................................................................................................................ 6 
2.0 Hypotheses: ....................................................................................................................................................... 8 
2.1 
Primary Objective(s) .................................................................................................................................... 8 
2.2 
Secondary Objective(s) ................................................................................................................................ 8 
3 
Patient Selection .............................................................................................................................................. 9 
3.1 
Inclusion Criteria ......................................................................................................................................... 9 
3.2 
Exclusion Criteria ........................................................................................................................................ 9 
3.3 
Inclusion of Women and Minorities ............................................................................................................ 10 
4 
Registration Procedures .................................................................................................................................. 10 
5.0     Study Outcomes and Study Measures ............................................................................................................. 11 
5.1 
Primary Outcome ...................................................................................................................................... 11 
5.2    Secondary Outcomes ................................................................................................................................. 11 
Table 1: Study Measures .................................................................................................................................... 12 
6.0     Intervention Plan .......................................................................................................................................... 12 
6.1 Methods ...................................................................................................................................................... 13 
6.1    Study-Related Activities ............................................................................................................................. 15 
6.2    Intervention Administration ........................................................................................................................ 17 
7.0     Adverse Event Reporting .............................................................................................................................. 18 
7.1 
Reporting of Unanticipated Problems, Adverse Events or Deviations ............................................................. 18 
7.2 
 WFUHS IRB AE Reporting Requirements .................................................................................................. 18 
7.3  
Data Safety and Monitoring .................................................................................................................... 19 
8.0 
 Data Management ..................................................................................................................................... 20 
9.0      Statistical Considerations ............................................................................................................................. 20 
9.1     Analysis of Primary Objective ................................................................................................................... 20 
9.2     Analysis of Secondary Objectives .............................................................................................................. 21 
9.4   Power and Sample Size ............................................................................................................................... 22 
9.5   Estimated Accrual Rate ............................................................................................................................... 22 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
Page 4 of 36 
9.6   Estimated Study Length .............................................................................................................................. 22 
References ............................................................................................................................................................ 23 
Appendix A – Eligibility Checklist ......................................................................................................................... 26 
Appendix B – Protocol Registration Form ............................................................................................................... 28 
Appendix C - Race & Ethnicity Verification Form ................................................................................................... 29 
Appendix D Safety and Toxicity Review Committee Serious Adverse Events SOP ..................................................... 30 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
Page 5 of 36 
 
SCHEMA 
 
 
 
 
 
 
 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
Page 6 of 36 
1.0 
Introduction and Background 
 
 
Cancer poses challenges to physical, emotional, and social well-being. Concerns such as health anxiety, 
depression, reduced social connectivity, and acute stress, often in the form of trauma, thread across all 
diagnostic groups and can become threats to vitality. Researchers found that 25% of American cancer survivors 
reported poor physical health-related quality of life (HRQOL) and 10% of cancer survivors reported poor 
mental HRQOL; in comparison, the non-cancer adult population was 10% and 6%, respectively (Weaver et al., 
2012). Impacts can be long lasting. Colorectal cancer survivors, for example, are at an increased risk for 
adjustment, anxiety, and substance-related disorders, delirium, dementia, body image concerns, and sexual 
dysfunction five years post-diagnosis (Lloyd et al., 2019). Cancer-related financial toxicity has been associated 
with higher levels of depressed mood, increased concerns about cancer recurrence, and an overall reduction in 
HRQOL (Kale & Carroll, 2016).  
 
The SARS II COVID-19 pandemic has infected millions of individuals and killed hundreds of thousands. 
Navigating cancer survivorship in the midst of a pandemic further complicates coping processes and normal 
avenues of support. Cancer survivors commonly contend with reduced immune functioning, placing many at 
higher risk for viral contagion and/or comorbidities. Many are advised to seek an even greater degree of social 
isolation. Researchers have analyzed data from the outbreak in China and found that cancer survivors presenting 
with COVID-19 face a higher risk of being admitted to an intensive care unit, being placed on a ventilator, or 
death than non-cancer patients presenting with COVID-19 (Liang et al., 2020). The presence of routine medical 
appointments and existing financial distress may position them to make complex decisions regarding their 
safety and behaviors during such a stressful time.  
While most global citizens have not endured a pandemic, data from recent epidemics can be informative as to 
psychological impacts. Researchers studying post-epidemic conditions have described the former SARS 
outbreak as a “mental health catastrophe,” with post-traumatic stress disorder (PTSD) as the most commonly 
noted psychiatric condition, followed by depressive disorders (Liang et al., 2020). Wu et al. (2005) found that 
people who perceived life threat during the SARS epidemic experienced anxiety, whereas depression was 
significantly associated with knowing someone who tested positive for SARS; the researchers also identified 
gender and education levels to be associated with avoidance symptoms. In 2009, researchers exploring long-
term psychiatric comorbidities among SARS survivors urged preparedness among health care professionals to 
detect and respond to the psychological sequelae that co-exist with infectious disease outbreaks (Mak et al., 
2008). Cancer survivors working to navigate disease survivorship and dynamic pandemic conditions then may 
be at even higher risk for emotional distress and trauma. 
In our current world, internet usage has become ubiquitous. In 2019, virtually all young adults (YAs) used the 
internet (100% of 18-29 year olds and 97% of 30-49 year olds) and the majority of middle aged (88% of 50-64 
year olds) and older adults (73% of those 65+) adopted this technology as well (Pew, 2019). Many people 
already use the internet as their primary source of health information, although only around 33% of adults have 
engaged in internet-based doctor-patient communication (Haluza et al., 2017). During the COVID-19 pandemic, 
more than half of U.S. adults (53%) have reported that the internet has been essential (Vogels et al., 2020). 
Furthermore, 64% of U.S. adults endorsed that the internet/phones will be useful but not a replacement for in-
person contact, while 27% rated that it will be just as good as in-person contact (Anderson & Vogels, 2020). 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
Page 7 of 36 
This indicates that many Americans are open to utilizing virtual methods in lieu of in person contact at this 
time. Therefore, utilizing effective online methods for mental health treatment behooves researchers and 
clinicians alike, now more than ever. Online group counseling is considered to be accessible and cost-effective, 
and it also eliminates the risk of in-person contact between providers and other patients.  
 
During the COVID-19 pandemic, it is reasonable to think that patients who have little to no experience with 
internet-based doctor-patient communication are rapidly being forced to adapt to these technologies. Cancer 
survivors in particular may find virtual telehealth interventions especially attractive due to the increased 
likelihood of exhibiting an immune-compromised status as well as the need to contend with frequent medical 
appointments that take them away from other responsibilities routinely. Particular sub-groups, including 
adolescent and young adults, rural or geographically distant, and economically distressed survivors, may find 
this modality especially inviting due to familiarity or enhanced access to care. YAs are considered to be digital 
natives because they have grown up in the digital age using the internet and computers, while digital immigrants 
are those who were not born into the digital world but rather adopted it at some point during their lifespan 
(Prensky, 2001). This distinction may be important in how users interact with, utilize, and adapt to technology 
use and online services. Recent research supports that digital immigrants (i.e., middle and older age adults) need 
additional coaching of how to use a technology than digital natives (Kasharwani, 2020). Additionally, digital 
natives were found to be more skeptical of the reliability of online health information and the reasonability of 
health information exchanged between providers and patients (Haluza et al., 2017). Thus, digital natives are a 
group that are able to adapt readily to the use of new technologies in novel contexts and they may better 
understand potential risks of utilizing an online platform.  
 
This supports that focusing on a YA group for an initial study of the feasibility of an online group therapy for 
cancer patients is reasonable. Additionally, having a group with a higher baseline knowledge of technology as 
well as higher rates of skepticism of online platforms may lead to helpful feedback for future iterations of the 
group that will target additional patient populations. The SARS-II COVID-19 pandemic has served as a catalyst 
for requisite social distancing as well as increased familiarity with virtual meetings for those with the 
technological capacity.  
 
Such a shared technological shift might make this type of group offering more feasible and attractive to 
prospective participants within the present circumstances. In response to the psychological vexations posed by 
simultaneous cancer and pandemic survivorship, we propose to create a virtual pandemic support group for 
cancer survivors that targets the constructs of health anxiety, depression, trauma, and social connectivity. The 
use of Acceptance and Commitment Therapy (ACT) (Arch & Mitchell, 2016) and Logotherapy (Mohabbat-
Bahar et al., 2014) with cancer survivorship groups has demonstrated promising results, including the reduction 
of anxiety, depression, fatigue, fear of cancer recurrence, physical pain, and trauma-related symptoms, while 
also increasing meaning and purpose in life and a feeling of regaining some control over one’s life. In line with 
the guiding principles of ACT and Logotherapy, this group will focus on coping strategies that enable positive 
psychosocial outcomes: Acceptance of cancer-related distress, reduction of cancer-related avoidance, 
identification of personal values, a commitment to making meaningful changes in one’s behavior, and 
identifying meaning and purpose in life (Arch & Mitchell, 2016; Mohabbat-Bahar et al., 2014). 
 
This will be a closed Young Adult (YA) group for the purposes of strategically covering essential skills needed 
for psychological flexibility, resilience, and meaning-making within these concurrent challenges to health. Pre-

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
Page 8 of 36 
and post-intervention assessments will assess change over time across a variety of variables, and researchers 
will analyze trends in self-selection and attrition to inform future interventions. 
Psychosocial oncology providers within a comprehensive cancer center have the responsibility to assess and 
respond to the dynamic mental health needs of those navigating cancer care within their communities. A 
pandemic both augments the need for and complicates the provision of mental health care. Demand and need 
for psychological care intensifies while factors impeding in-person provision of care also multiply. To cater to 
the mental health needs of cancer survivors within evolving pandemic conditions, we plan to open groups that 
allow access to survivors coping with similar challenges. By offering carefully constructed virtual groups that 
target psychological symptoms and coping skills applicable to these dual health threats, we aim to empower and 
support the development of transferable coping skills within YA cancer survivors within our community. It is 
our hope that improved psychological flexibility will result in improved coping within their cancer care and 
pandemic responses. 
2.0 Hypotheses: 
 
Participants will demonstrate improvements in:  
self-efficacy, psychological flexibility, resilience, social connectivity, sense of purpose and meaning 
Participants will demonstrate reductions in:  
loneliness, anxiety, depression, helpless/hopeless feelings 
2.1 
Primary Objective(s) 
 
2.1.1 
To improve self-efficacy for young adult cancer survivors navigating pandemic conditions 
2.2 
Secondary Objective(s) 
2.2.1 
To reduce depression and anxiety levels through meaning-making. 
 
2.3 
Exploratory Analyses: 
 
2.3.1 
To assess the feasibility of conducting a telehealth support group for cancer survivors within a 
pandemic. 
2.3.2 
To assess YA cancer survivors’ interest in participation in a telehealth support group within a 
pandemic. 
2.3.3 
To enhance participants’ strategies for engaging social connectivity and reduce feelings of 
loneliness amidst simultaneous forces promoting self-isolation (i.e., cancer diagnosis and 
pandemic). 
2.3.4 
To observe improvement in psychological resilience and flexibility skills in participants 
2.3.5 
To reduce feelings of helplessness. 
2.3.6 
To increase distress tolerance. 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
Page 9 of 36 
3 Patient Selection 
Recruitment: 
Investigators will attempt to recruit prospective participants through: 
• 
Informing oncologists, APPs, and other clinicians who work with potentially eligible patients 
• 
Advertising through hospital channels (clinic flyers, wating room TVs, intranet postings) 
• 
Contacting YAs who have participated in former clinical or research offerings and shared their contact 
information (existing databases from Psychosocial Oncology and Public Health Sciences) 
• 
Existing psychosocial oncology caseload 
Experienced Investigators within the Psychosocial Oncology group will reach out to identified patients 
telephonically for introduction and pre-screens. The study will be explained and patients will be asked to 
answer the questions on the Pre-Screening form. Individuals who are interested in participating but do not meet 
eligibility criteria will be referred to an alternate, general support group and informed about future offerings for 
which they might be eligible. 
 
3.1 
Inclusion Criteria  
 
3.1.1 
Documented cancer diagnosis within the WFBMC medical record;  
 
3.1.2 
Outpatient Cancer Survivor (diagnosis, treatment, or post-treatment);   
 
3.1.3 
Aged 18-39; 
 
3.1.4 
Must speak English 
 
3.1.5 
Must have computer with audio and visual capabilities. 
 
3.1.6 
Must live within North Carolina  
 
3.1.7 Must have experienced health-related anxiety and/or distress in last 3 months.   
 
3.2 
Exclusion Criteria  
Exclusion criteria will be determined by pre-screening data and medical chart reviews 
 
3.2.1 
Active inpatient hospitalization; 
 
3.2.2 
Major cognitive impairment, marked concerns with working memory, concentration, or word 
finding difficulties that significantly impairs daily functioning documented in most recent clinic 
note or self-reported; 
 
3.2.3 
Recent suicide attempt(s), psychiatric hospitalization, or psychotic processing (last 3 years); 
 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
Page 10 of 36 
3.2.4 
Bipolar disorder (I or II) diagnosis, as evidenced by an ICD-10 code within the past year or 
revealed during subject interview  
 
3.2.5 
Moderate to severe alcohol or drug abuse; as evidenced by an ICD-10 codes related to alcohol or 
illicit substance abuse in the medical record within the past year or revealed during subject 
interview. 
 
3.2.6 
Severe eating disorders; as evidenced by an ICD-10 code in the medical record such as anorexia 
nervosa or bulimia  within the past year or revealed during patient interview 
 
3.2.7 
Repeated “acute” crises for example: repeated acute crises consisting of marked psychological 
distress that impairs function and warrants clinician intervention (e.g., occurring once a month or 
more frequently); this we be evaluated by the clinician screener 
 
 
3.3 
Inclusion of Women and Minorities 
 
Men and women of all races and ethnicities who meet the above-described eligibility criteria are 
eligible to participate in this study.  
 
Based on WFBCCC population estimates, we expect approximately 45% of participants to be 
women. Translating this to our sample size estimate of 15, we plan to enroll at least 7 women. 
Similarly, we expect approximately 3% of study participants to be Hispanic/Latino (N=~1). We 
plan to enroll at least 13% Black or African American (N=2). Due to the small sample size we do 
not anticipate recruiting American Indian/Alaska Native, or Asian subjects; however no eligible 
subjects will be denied participation. Should we not meet or exceed these estimates, the PI will 
engage the Office of Cancer Health Equity to discuss strategies to enhance recruitment in these 
target populations. 
 
4 Registration Procedures 
 
All patients entered on any WFBCCC trial, whether treatment, companion, or cancer control trial, must be 
linked to the study in EPIC within 24 hours of Informed Consent. Patients must be registered prior to the 
initiation of treatment.   
 
You must perform the following steps in order to ensure prompt registration of your patient: 
 
1. Complete the Eligibility Checklist (Appendix A) 
2. Complete the Protocol Registration Form (Appendix B) 
3. Alert the Cancer Center registrar by phone, and then send the signed Informed Consent Form, Eligibility 
Checklist and Protocol Registration Form to the registrar, either by fax or e-mail. 
 
 
Contact Information: 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
Page 11 of 36 
Protocol Registrar PHONE
 
Protocol Registrar FAX (336) 713-6772 
Protocol Registrar E-MAIL (registra@wakehealth.edu) 
            
*Protocol Registration is open from 8:30 AM - 4:00 PM, Monday-Friday. 
 
4. Fax/e-mail ALL eligibility source documents with registration. Patients will not be registered without all 
required supporting documents. 
Note: If labs were performed at an outside institution, provide a printout of the results. Ensure that the 
most recent lab values are sent. 
 
To complete the registration process, the Registrar will:   
 
• assign a patient study number 
• other appropriate actions 
• register the patient on the study 
5.0     Study Outcomes and Study Measures 
 
5.1    Primary Outcome 
 
5.1.1 
To measure self-efficacy for young adult cancer survivors navigating pandemic conditions. 
5.2    Secondary Outcomes 
 
5.1.2 
To reduce depression and anxiety levels through meaning-making. 
 
5.3  
Exploratory Analyses 
 
5.1.3 
To assess the feasibility of conducting a telehealth support group for cancer survivors within a 
pandemic. 
5.1.4 
To assess YA cancer survivors’ interest in participation in a telehealth support group within a 
pandemic. 
5.1.5 
To enhance participants’ strategies for engaging social connectivity and reduce feelings of 
isolation amidst simultaneous forces promoting self-isolation (i.e., cancer diagnosis and 
pandemic). 
5.1.6 
To reduce feelings of helplessness. 
5.1.7 
To observe improvement in psychological resilience and flexibility skills in participants.  
5.1.8 
To increase distress tolerance.

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
Page 12 of 36 
 
 
0BTable 1: Study Measures 
Type/Purpose 
of Measure 
 
Variable 
 
Measures 
Primary 
Outcomes 
 
Self-Efficacy 
 
Cancer Behaviour Inventory-brief version (CBI-B) 
Secondary 
Outcomes 
 
Depression and Anxiety Level 
 
CAS, MINI MAC, and Purpose in Life Test 
Exploratory 
Analyses 
Feasibility 
Interest 
Social Connectivity 
Psychological resilience and 
flexibility skills 
Helplessness and Hopelessness 
Distress tolerance 
Number of subjects participating at the final visit 
Number of Sessions Attended 
UCLA Loneliness Scale 
Acceptance and Action questionnaire (AAQ) 
 
MINI MAC 
Impact of Event Scale (IES) 
 
6.0     Intervention Plan 
 
The study aims to initially recruit a single cohort of 15 patients. This is a virtual group interventional design in 
which investigators distribute the electronic assessment battery, perform the intervention, assess mid-way 
through, and reassess post-intervention. The virtual group will be conducted within a secure platform such as 
Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual 
platform, as will session handouts and forms. If participants do not have headphones, these will be provided by 
the study team. The biostatistician will assist with the assessment of change over time within the 
instrumentation. The session content for this group is built on clinical experience and empirically informed 
practices, drawing upon elements of Acceptance and Commitment Therapy and Meaning Making approaches. 
Investigators/facilitators believe that in these unique times, it is optimal to pull elements from various 
(manualized) approaches that contribute important elements to the group experience. In short, we are making 
intentional decisions within session design in which we draw heavily from empirically supported practices yet 
combine them in a manner that seems appropriate for the circumstances based on clinical judgment. 
 
The intervention will be conducted by graduate-prepared mental health providers who are licensed or working 
under the supervision of a licensed provider. Providers will co-facilitate at all times, with two providers 
available to respond to group dynamics and follow up with individual members as needed. 
 
The clinicians leading the group will adhere to professional, legal, and ethical guidelines of confidentiality 
established by professional organizations and state law. Legal and ethical exceptions to confidentiality include: 
A clear or present danger that the patient intends to harm her/himself or another, knowledge of the abuse or 
neglect of a minor child or incapacitated adult, or responses to a court subpoena or as otherwise required by 
law. All members of the group will be required to sign confidentiality forms, in which they agree not to disclose 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
Page 13 of 36 
to anyone outside the group any information that may help to identify another group member. This includes, but 
is not limited to names, physical descriptions, biological information, and specifics to the content of interactions 
with other group members. 
 
6.1 Methods 
Steps: (Conducted by the Psychosocial Oncology group) 
1. 
Advertise and Identify Prospective Candidates 
2. 
Screen all referred candidates on rolling basis  
3. 
Send out pre-group assessments electronically for completion 
4. 
Begin eight weeks of group work 
5. 
Send out post-group assessments electronically for completion  
Session Content  
Adapted from Eilenberg, Frostholm, & Kronstrand 2014 with elements on meaning making from 
Breitbart & Poppito, 2005, rev. 2011: 
Session 1: Introduction to ACT and Meaning Making 
Summary: The purpose of the 1st session is to introduce the framework and form of the group, as well 
as expectations for the 8 sessions. Our main focus is on willingness to engage in treatment, a basic 
understanding of ACT, mindfulness, and the importance and sources of meaning making—creative, 
experiential, historical, and attitudinal. We will start to practice experiencing each from this first 
session. The purpose is to introduce the framework of the group, logistics, and to create a safe and 
accepting atmosphere. Furthermore, we will briefly introduce participants to an understanding of what 
health anxiety in the context of cancer is. 
  
 
 
 
 
 
 
Session 2:  
Previous strategies for Anxiety Control    
 
 
 
 
 
 
Summary: The purpose of this session is to examine the individual's control strategies and experiences 
in coping with health anxiety. We will introduce the concept of pain vs. suffering and how cancer can 
enhance life meaning, maintain life meaning, or create loss of meaning.  The purpose is to help the 
individual to examine whether the previously used strategies have been effective in the short- and long- 
term in relation to living a values-based, meaningful life.  
Session 3:Introduction to Values Based Living   
  
 
 
 
 
 
 
Summary: The purpose of session 3 is to extend the insights and experiences from the last session in 
relation to the control agenda’s limited effect on anxiety. Through experiential exercises, the effect of 
the control agenda is further tested and examined. Further, values-based living is introduced as an 
alternative to an avoidance and control-driven life. Values are introduced in the context of willingness 
and a discussion will introduce “Life as Legacy” both in the past, the here-and-now, and the future.  
Session 4: Acceptance as an Alternative to Control 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
Page 14 of 36 
Summary: The purpose of session 4 is to introduce acceptance as an alternative to attempting to 
control anxiety. The control-agenda is additionally challenged by looking at the lack of success in 
applying these strategies to internal states. Remind participants that mindfulness is a practice in 
willingness and that willingness may increase the ability to act on life. Acting on life includes being 
courageous, creative, and responsible. 
Session 5: Defusion-A Method for Distancing Yourself from your Thoughts 
Summary: The purpose of session 5 is to introduce the concept of defusion through various exercises. 
Participants experience the difference between being immersed in thoughts and experiencing distance 
from worrisome thoughts. Participants will be introduced to the techniques with a focus on creating 
distance from thoughts (e.g., Leaves on a Stream), as this can help the participant to act on thoughts and 
feelings in line with their values and purpose in life—rather than use control and avoidance behaviors. 
Experiential sources of love, beauty, and humor enhance one’s ability to “Connect with Life.” 
Session 6:  Identifying and Clarifying Values 
Summary: The purpose of session 6 is to help participants further identify and clarify their own values 
and meaning in life in order to provide direction in their lives when treatment ends. Value-based action 
is introduced as an opportunity to expand the participants’ repertoire with activities other than 
avoidance behavior, control or excessive preoccupation with bodily sensations. Participants will engage 
in creating a legacy project to foster creative, experiential, historical, and attitudinal meaning making. .  
Session 7: Practice Observing Yourself 
Summary: The purpose of session 7 is to provide an understanding and personal experience of the 
observing self—the perspective from which you can create distance from your thoughts and work with 
mindfulness techniques. The concept of the observing self can be crucial in terms of creating 
willingness to experience difficult feelings and observe thoughts, etc. without having to react 
automatically.  
Session 8: Living Your Values 
Summary: The purpose of session 8 is to help the individual further clarify their values and purpose in 
life by defining specific value-based steps which can be taken moving forward. Participants will share 
their Legacy Projects. The group is prepared for the end of the program by working on how to manage 
obstacles while continuing to move forward in life. The group will process termination.  
 
Social media: 
Many virtual group members like to meet on their own exterior to group meetings. While we will not 
sponsor such activities, group members are free to create forums for such interaction. During our 
groundrules session, we will discuss potential pros and cons of engaging in such social interaction. 
 
 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
Page 15 of 36 
6.1    Study-Related Activities  
 
 
 
Pre- 
Studya 
Introduction 
to ACT and 
Meaning 
Making 
Week 1 
Previous 
strategies for 
Anxiety 
Control 
Week 2 
Introduction 
to Values 
Based Living 
Week 3 
Acceptance 
as an 
Alternative 
to Control 
Week 4 
Mid-Point  
Assessment 
Defusion-A 
Method for 
Distancing 
Yourself from 
your Thoughts 
Week 5 
Identifying 
and 
Clarifying 
Values 
Week 6 
Practice 
Observing 
Yourself 
Week 7 
Living 
Your 
Values 
Week 8 
Post-study 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
Medical history 
 
 
 
 
 
 
 
 
 
 
 
Pre-screening 
questionnaire: 
X 
 
 
 
 
 
 
 
 
 
 
Group Evaluation 
Questionnaire: 
 
 
 
 
 
X 
 
 
 
 
X 
Instrumentation 
Coronavirus Anxiety 
Scale (CAS)  
X 
 
 
 
 
X 
 
 
 
 
X 
Acceptance and 
Action Questionnaire 
(AAQ) 
X 
 
 
 
 
X 
 
 
 
 
X 
The Cancer Behaviour 
Inventory-brief 
version (CBI-B)  
X 
 
 
 
 
X 
 
 
 
 
X 
The Mini-Mental 
Adjustment to Cancer 
(MINI-MAC) 29-item 
questionnaire  
X 
 
 
 
 
X 
 
 
 
 
X 
 UCLA Loneliness 
Scale Version 3 
X 
 
 
 
 
X 
 
 
 
 
X 
The Impact of Event 
Scale - Revised (IES-
R) 
X 
 
 
 
 
          X 
 
 
 
 
X 
The Purpose in Life 
Test 
X 
 
 
 
 
X 
 
 
 
 
X 
Group Sessions 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
Page 16 of 36 
a  The instruments are sent out the first week of ten weeks (week one=pre-intervention instruments sent; eight week intervention; 
post-instruments are pushed at week ten).

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
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6.2    Intervention Administration 
 
Instrumentation 
Coronavirus Anxiety Scale (CAS)  
“CAS is a reliable instrument (αs > .90), with solid factorial (single-factor; invariant across 
sociodemographics) and construct (correlated with anxiety, depression, suicidal ideation, and 
drug/alcohol coping) validity. The diagnostic properties of the CAS (90% sensitivity and 85% 
specificity) are comparable to related screening instruments, such as the Generalized Anxiety Disorder-
7” (Lee, 2020). 
 
Acceptance and Action Questionnaire (AAQ)  
 
Acceptance and Action questionnaire (AAQ) assesses psychological inflexibility. It has been found to 
have high internal consistency and reliability across different types of psychopathology illnesses and 
different target groups.  
 
Cancer Acceptance and Action Questionnaire 
 
This 18-item questionnaire is used to assess psychological flexibility in cancer patients. It presents 
experiences such as avoidance and painful memories.  
The Cancer Behaviour Inventory-brief version (CBI-B)  
 
12-item validated questionnaire used widely as a measure of self-efficacy for coping with cancer, 
derived from the longer 33-item version. CBI-B has been reported to have good internal reliability (a = 
0.84) and construct validity. The CBI-B measures coping self-efficacy. 
 
The Mini-Mental Adjustment to Cancer (MINI-MAC) 29-item questionnaire  
 
The Mini-MAC is a 29-item questionnaire measures patients’ present experiences using a 4-point Likert 
scale ranging from ‘‘Definitely does not apply to me’’ (1) to ‘‘Definitely apply to me’’ (4). Five 
subscales include: Helpless–Hopeless, Anxious Preoccupation, Cognitive Avoidance, Fighting Spirit 
and Fatalism.  
UCLA Loneliness Scale Version 3  
 
A 20-item scale designed to measure one’s subjective feelings of loneliness as well as feelings of social 
isolation. Participants rate each item on a scale from 1 (Never) to 4 (Often). The measure has high 
internal consistency (coefficient alpha = .96) and a test-retest correlation over a two-month period of .73. 
  
The Impact of Event Scale - Revised (IES-R) 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
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Wake Forest Baptist Comprehensive Cancer Center 
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A short, easily administered self-report questionnaire that has eight intrusion and eight avoidance items, 
derived from the original IES. Six additional items assess for hyperarousal.  
 
The Purpose in Life Test  
 
This self-report questionnaire has 20 items that measure a person’s sense of purpose and meaning in life and is 
based on Viktor Frankl’s Logotherapy (Davies et al., 2014). Good reliability has been found, with split-half 
reliability coefficients of .90. 
 
Pre-screening questionnaire 
This investigator-created instrument is designed to assess group suitability, with attention to inclusion 
and exclusion criteria. It also will include technology training for group technology requirements. 
Group Evaluation Questionnaire 
This investigator-created instrument is designed to assess satisfaction and solicit feedback. It also will 
have questions pertaining to engagement with other group members exterior to group meetings. 
7.0     Adverse Event Reporting  
7.1 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Due to the nature and scope of this study, we do not anticipate any adverse events. However, 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. The PI will be responsible for the 
monitoring and reporting of any adverse events. The co-investigators will be consulted as appropriate. 
All problems having to do with subject safety will be reported by the PI to the IRB. Specifically, the 
following will be reported, in writing: 1) all serious adverse events associated with the study procedures, 
and/or 2) any incidents or problems involving the conduct of the study or participation, including 
problems with the recruitment and/or consent processes. The PI will provide a discussion of any 
problems noticed during each year in the course of the study to the IRB on an annual basis 
7.2 
 WFUHS IRB AE Reporting Requirements 
 
Any unanticipated problems involving risks to subjects or others and adverse events shall be promptly 
reported to the IRB, according to institutional policy. Reporting to the IRB is required regardless of the 
funding source, study sponsor, or whether the event involves an investigational or marketed drug, 
biologic or device. Reportable events are not limited to physical injury, but include psychological, 
economic and social harm. Reportable events may arise as a result of drugs, biological agents, devices, 
procedures or other interventions, or as a result of questionnaires, surveys, observations or other 
interactions with research subjects. 
 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
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All members of the research team are responsible for the appropriate reporting to the IRB and other 
applicable parties of unanticipated problems involving risk to subjects or others. The Principal 
Investigator, however, is ultimately responsible for ensuring the prompt reporting of unanticipated 
problems involving risk to subjects or others to the IRB. The Principal Investigator is also responsible 
for ensuring that all reported unanticipated risks to subjects and others which they receive are reviewed 
to determine whether the report represents a change in the risks and/or benefits to study participants, and 
whether any changes in the informed consent, protocol or other study-related documents are required. 
 
Any unanticipated problems involving risks to subjects or others occurring at a site where the study has 
been approved by the WFUHS IRB (internal events) must be reported to the WFUHS IRB within 7 
calendar days of the investigator or other members of the study team becoming aware of the event. 
 
Any unanticipated problems involving risks to subjects or others occurring at another site conducting the 
same study that has been approved by the WFUHS IRB (external events) must be reported to the 
WFUHS IRB within 7 calendar days of the investigator or other members of the study team becoming 
aware of the event. 
 
Any event, incident, experience, or outcome that alters the risk versus potential benefit of the research 
and as a result warrants a substantive change in the research protocol or informed consent 
process/document in order to insure the safety, rights or welfare of research subjects. 
 
7.3  
Data Safety and Monitoring 
Since the study is a treatment for mental health concerns such as depression and anxiety, it is likely 
several participants may endorse clinical levels of each. Current/recent suicidality is an exclusion criteria 
for this study, therefore those who endorse that upfront will not be enrolled in the study and will be 
given alternative options (e.g., referred for other CPSP services). If a participant does express suicidal or 
homicidal ideation at any point throughout the 8 sessions, a therapist will engage them in a personal 
discussion outside of the group to further assess safety additionally, the study will require that patients 
allow us to have their preferred phone number and physical address on hand (we have in med chart but 
have them consent to us using for this purpose) so that appropriate follow-up after video sessions can 
occur if there is concern for personal harm or the need for a private conversation.  Additionally the study 
team will request emergency contact information of a friend or family member who will be contacted in 
the event that the study team cannot reach the participant.  If a patient endorses active suicidality during 
the group, we will refer them to appropriate follow up depending on the level (e.g., referred to CPSP 
individually, call 911/ED for imminent danger). 
  
7.3.1 DSMC SAE Reporting Requirements  
The Data Safety Monitoring Committee (DSMC) is responsible for reviewing SAEs for CCCWFU 
Institutional studies as outlined in Appendix D. All Adverse Events that occur during protocol intervention 
(defined below) and are coded as either 1) unexpected grade 4, 2) unplanned inpatient hospitalization > 
24 hours (regardless of grade), or grade 5 (death) must be reported to the DSMC using the using the SAE 
console in WISER. 
 
All CCCWFU Clinical Research Management (CRM) staff members assisting a Principal Investigator in 

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investigating, documenting and reporting an SAE qualifying for DSMC reporting are responsible for 
informing a clinical member of the DSMC as well as the entire committee via the email notification 
procedure of the occurrence of an SAE.  
 
 
8.0 
 Data Management 
 
Informed consent document 
EPIC 
Protocol registration form 
WISER/OnCore 
Coronavirus Anxiety Scale (CAS)  
REDCap 
Acceptance and Action Questionnaire (AAQ) 
[free, if a member of ACBS: 
REDCap 
The Cancer Behaviour Inventory-brief version 
(CBI-B) 
REDCap 
The Mini-Mental Adjustment to Cancer 
(MINI-MAC) 29-item questionnaire 
REDCap 
UCLA Loneliness Scale Version 3 
REDCap 
The Impact of Event Scale - Revised (IES-R) 
REDCap 
Purpose in Life Test 
REDCap 
Pre-screening questionnaire 
REDCap 
Group Evaluation Questionnaire 
REDCap 
Off study/Off Treatment/Survival 
WISER/OnCore 
 
This project will utilize REDCap Clinical Data Interoperability Services. This is a special feature for importing 
data into REDCap from WakeOne. It provides an adjudication process whereby REDCap users can approve all 
incoming data from WakeOne before it is officially saved in their REDCap project. REDCap Clinical Data 
Interoperability Services can only be enabled by a REDCap administrator who serves as an honest broker to 
PHI. REDCap’s Clinical Data Interoperability Services can only be accessed by users with valid WakeOne 
credentials. Using the Clinical Data Interoperability Service requires using the Medical Record Number (MRN) 
as a key to automatically gather demographics and laboratory data and reduces data entry errors. 
 
9.0      Statistical Considerations 
 
9.1     Analysis of Primary Objective 
The primary outcome, the improvement of self-efficacy for young adult cancer survivors navigating 
pandemic conditions, will be assessed by comparing the change in the Cancer Behaviour Inventory-brief 
version (CBI-B) from baseline to Visit 8.  With an n of 15, power of 80% and a 2-sided alpha of 0.05, 
the confidence interval around our baseline, Visit 4,Visit 8, and change scores would have a width of 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
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approximately 1.02 standard deviations.   To test the change over the 8 weeks, a paired t-test (using the 
baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B 
between the 2 scores would be no change (null hypothesis is mean is equal to 0).  We would also 
calculate the difference between baseline and Visit 4 and test to see if that mean is significantly different 
from 0; this will help us understand that if a change occurs, does it occur earlier in the intervention or 
does the change happen closer to the end of the intervention. 
 
9.2     Analysis of Secondary Objectives 
To reduce depression and anxiety levels through meaning-making, three instruments will provide 
information on baseline, Visit 8, and change over time.  The CAS, MINI MAC, and Purpose in Life Test 
will all be utilized to estimate depression and anxiety levels.  With an n of 15, the width of the 
confidence interval around the baseline, Visit 4, Visit 8, and change between baseline and Visit 4 as well 
as Visit 8 scores would be approximately 1.02 standard deviations; a paired t-test will be used to assess 
the change in the scores.  As this is a pilot study, no adjustment in the p-value will be done for multiple 
comparisons. 
 
 
9.3 Exploratory Analyses 
 
9.3.1 To assess the feasibility of conducting a telehealth support group for cancer survivors 
within a pandemic, we will measure how many subjects are still participating at the final visit 
(Visit 8); the proportion of subjects who are active at this visit can be calculated as n/enrollment 
(with the expectation of approximately 15 enrolled).  When the sample size is 15, a two-sided 
95% confidence interval for a single proportion will extend 25.3% from the observed proportion 
for an expected proportion of 50%; if the proportion is low or high, such as 10% or 90%, a two-
sided 95% confidence interval will extend 15.2% from the observed proportion. These data could 
be used in sample size calculations to design future studies. 
 
 
9.3.2 To assess YA cancer survivors’ interest in participation in a telehealth support group within 
a pandemic, the data would be used to estimate the percentage of sessions attended for each 
participant and calculate the mean participation rate and standard deviation; these data could also 
be expressed as mean number of visits and standard deviation.  These data could be used to help 
design future studies. 
 
9.3.3 To enhance participants’ strategies for engaging social connectivity and reduce feelings of 
isolation amidst simultaneous forces promoting self-isolation (i.e., cancer diagnosis and 
pandemic), the UCLA Loneliness Scale will be used.  As this is a continuous measure, with an n 
of 15, the width of the confidence interval around the baseline,Visit 4, Visit 8, and change 
between baseline and Visit 4 as well as Visit 8 scores would be approximately 1.02 standard 
deviations; a paired t-test will be used to assess the change in the scores.  As this is a pilot study, 
no adjustment in the p-value will be done for multiple comparisons. 
 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
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Wake Forest Baptist Comprehensive Cancer Center 
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9.3.4 To observe improvement in psychological resilience and flexibility skills in participants, 
the Acceptance and Action questionnaire (AAQ) will be used to estimate flexibility.  As in 9.1, 
with an n of 15, the width of the confidence interval around the baseline, Visit 4,Visit 8, and 
change between baseline and Visit 4 and baseline and visit 8 scores would be approximately 1.02 
standard deviations; a paired t-test will be used to assess the change in AAQ.  As this is a pilot 
study, no adjustment in the p-value will be done for multiple comparisons. 
 
9.3.5 To reduce feelings of helplessness and hopelessness, the MINI MAC will be used.  With an 
n of 15, the width of the confidence interval around the baseline,Visit 4,Visit 8, and change 
between baseline and Visit 4 as well as Visit 8  scores would be approximately 1.02 standard 
deviations; a paired t-test will be used to assess the change in the scores.  As this is a pilot study, 
no adjustment in the p-value will be done for multiple comparisons. 
 
 
9.3.6 To increase distress tolerance, the Impact of Event Scale (IES) will be used to assess this 
measure. With an n of 15, the width of the confidence interval around the baseline,Visit 4,Visit 
8, and change between baseline and Visit 4 as well as Visit  scores would be approximately 1.02 
standard deviations; a paired t-test will be used to assess the change in the scores.  As this is a 
pilot study, no adjustment in the p-value will be done for multiple comparisons. 
 
9.4   Power and Sample Size 
With the planned sample size is 15, a two-sided 95% confidence interval for a single proportion will 
extend 25.3% from the observed proportion for an expected proportion of 50%; if the proportion is low 
or high, such as 10% or 90%, a two-sided 95% confidence interval will extend 15.2% from the observed 
proportion.  If the outcome is continuous, with an n of 15, power of 80% and a 2-sided alpha of 0.05, the 
confidence interval around the estimate would have a width of approximately 1.02 standard deviations. 
 
9.5   Estimated Accrual Rate 
The study should accrue all subjects within a short period of time, approximately 4 weeks, based on a 
goal of 3 to 4 patients each week. 
 
9.6   Estimated Study Length 
The study should take 8 weeks to complete the visits, with a week of training before the study begins 
and another week to send out forms after the study ends, for a total of approximately 10 weeks. 
 
 
 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
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Wake Forest Baptist Comprehensive Cancer Center 
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References 
Anderson, M., & Vogels, E. A. (2020). Americans turn to technology during COVID-19 outbreak, say an 
outage would be a problem. Pew Research Center. https://www.pewresearch.org/fact-
tank/2020/03/31/americans-turn-to-technology-during-covid-19-outbreak-say-an-outage-would-be-a-problem/ 
 
Arch, J. J., & Mitchell, J. L. (2016). An Acceptance and Commitment Therapy (ACT) group intervention for 
cancer survivors experiencing anxiety at re-entry. Psycho-Oncology, 25(5), 610–615. 
https://doi.org/10.1002/pon.3890 
 
Breitbart, W. & Poppito, S.R. (2005, 2011). Meaning-centered group psychotherapy treatment manual. 
New York, NY: Memorial Sloan-Kettering Cancer Center. 
 
Davies G., Klaassen D., Längle A. (2014). Purpose in Life Test. In: Michalos A.C. (eds) Encyclopedia of 
Quality of Life and Well-Being Research. Springer, Dordrecht. 
 
Eilenberg, T., Frostholm, L., & Kronstrand, L. (2014). Acceptance & commitment group therapy (ACT-G) for 
severe health anxiety. Aarhus, Denmark: Aarhus University Hospital Research Clinic for Functional Disorders 
and Psychosomatics. 
 
Haluza, D., Naszay, M.,  Stockinger, A., & Jungwirth, D. (2017) Digital Natives Versus Digital Immigrants: 
Influence of Online Health Information Seeking on the Doctor–Patient Relationship. Health Communication, 
32(11), 1342-1349. DOI: 10.1080/10410236.2016.1220044 
 
Kale, H. P., & Carroll, N. V. (2016). Self-reported financial burden of cancer care and its effect on physical and 
mental health-related quality of life among US cancer survivors. Cancer, 122(8), 283–289. 
https://doi.org/10.1002/cncr.29808 
Kesharwani, A. (2020). Do (how) digital natives adopt a new technology differently than digital immigrants: A 
longitudinal study. Information & Management, 57, 103170. https://doi.org/10.1016/j.im.2019.103170  
 
Lee, S. A. (2020). Coronavirus Anxiety Scale: A brief mental health screener for COVID-19 related anxiety. 
Death Studies. https://doi.org/10.1080/07481187.2020.1748481 
 
Liang, W., Guan, W., Chen, R., Wang, W., Li, J., Xu, K., Li, C., Ai, Q., Lu, W., Liang, H., Li, S., & He, J. 
(2020). Cancer patients in SARS-CoV-2 infection: A nationwide analysis in China. The Lancet Oncology, 
21(3), 335–337. https://doi.org/10.1016/S1470-2045(20)30096-6 
 
Lloyd, S. , Baraghoshi, D. , Tao, R. , Garrido-Laguna, I. , Gilcrease, G. W. , Whisenant, J. , Weis, J. R. , Scaife, 
C. , Pickron, T. B. , Huang, L. C. , Monroe, M. M. , Abdelaziz, S. , Fraser, A. M. , Smith, K. R. , Deshmukh, 
V. , Newman, M. , Rowe, K. G. , Snyder, J. , Samadder, N. J. & Hashibe, M. (2019). Mental Health Disorders 
are More Common in Colorectal Cancer Survivors and Associated With Decreased Overall Survival. American 
Journal of Clinical Oncology, 42(4), 355–362. doi: 10.1097/COC.0000000000000529. 
 

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Mak, I. W. C., Chu, C. M., Pan, P. C., Yiu, M. G. C., & Chan, V. L. (2009). Long-term psychiatric morbidities 
among SARS survivors. General Hospital Psychiatry, 31(4), 318–326. 
https://doi.org/10.1016/j.genhosppsych.2009.03.001 
Mohabbat-Bahar, S., Golzari, M., Moradi-Joo, M., & Akbari, M. E. (2014). Efficacy of group logotherapy on 
decreasing anxiety in women with breast cancer. Iranian journal of cancer prevention, 7(3), 165–170. 
 
Pew Research. (June, 2019). Internet/broadband Fact Sheet. https://www.pewresearch.org/internet/fact-
sheet/internet-broadband/ 
 
Prensky, M. (2001). Digital Natives, Digital Immigrants. On the Horizon, 9(5), 1-6.  
 
Vogels, E. A., Perrin, A., Rainie, L., & Anderson, M. (2020). 53% of Americans Say the Internet Has Been 
Essential During the COVID-19 Outbreak. Pew Research Center. 
https://www.pewresearch.org/internet/2020/04/30/53-of-americans-say-the-internet-has-been-essential-during-
the-covid-19-outbreak/ 
 
Wu, K. K., Chan, S. K., & Ma, T. M. (2005). Posttraumatic stress, anxiety, and depression in survivors of 
severe acute respiratory syndrome (SARS). Journal of Traumatic Stress, 18(1), 39–42. 
https://doi.org/10.1002/jts.20004 
Weaver, K. E., Forsythe, L. P., Reeve, B. B., Alfano, C. M., Rodriguez, J. L., Sabatino, S. A., Hawkins, N. A., 
& Rowland, J. H. (2012). Mental and Physical Health–Related Quality of Life among U.S. Cancer Survivors: 
Population Estimates from the 2010 National Health Interview Survey. Cancer Epidemiology and Prevention 
Biomarkers, 21(11), 2108–2117. https://doi.org/10.1158/1055-9965.EPI-12-0740 
 
 
 

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The following Appendices are required for all WFBCCC cancer treatment protocols. 
 
Add additional appendices as needed. 
 
ALL data collection forms must be included as protocol appendices at the time the protocol is submitted to the 
WFBCCC Protocol Review Committee (PRC) for review. 
 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
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Appendix A – Eligibility Checklist 
 
 
IRB Protocol No.  
WFBCCC Protocol No. 01520 
Study Title: Cancer within a Pandemic: A Telehealth Intervention Designed to Augment Psychological Resilience amidst Dual 
Health Threats 
Principal Investigator:  Katharine E. Duckworth, 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) 
Documented cancer diagnosis within the 
WFBMC medical record 
□ 
□ 
 
Meets all pre-screen eligibility criteria 
 
□ 
□ 
 
Outpatient Cancer Survivor (diagnosis, 
treatment, or post-treatment)   
 
□ 
□ 
 
Aged 18-39 
□ 
□ 
 
Must speak English 
 
□ 
□ 
 
Must have computer with audio and visual 
capabilities 
 
□ 
□ 
 
Must live within North Carolina  
 
□ 
□ 
 
Must have experienced health-related anxiety 
and/or distress in last 3 months 
 
□ 
□ 
 
Exclusion Criteria 
(as outlined in study protocol) 
Criteria 
NOT 
present 
Criteria is 
present 
Source Used to Confirm * 
(Please document dates and lab results) 
Active inpatient hospitalization; 
□ 
□ 
 
Major cognitive impairment, marked 
concerns with working memory, 
concentration, or word finding difficulties 
that significantly impairs daily functioning 
documented in most recent clinic note or self-
reported; 
□ 
□ 
 
Recent suicide attempt(s), psychiatric 
hospitalization, or psychotic processing (last 
3 years); 
□ 
□ 
 

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Wake Forest Baptist Comprehensive Cancer Center 
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Bipolar disorder (I or II) diagnosis, as 
evidenced by an ICD-10 code within the past 
year or revealed during subject interview  
 
□ 
□ 
 
Moderate to severe alcohol or drug abuse; as 
evidenced by an ICD-10 codes related to 
alcohol or illicit substance abuse in the 
medical record within the past year or 
revealed during subject interview. 
 
□ 
□ 
 
Severe eating disorders; as evidenced by an 
ICD-10 code in the medical record such as 
anorexia nervosa or bulimia  within the past 
year or revealed during patient interview 
 
□ 
□ 
 
Repeated “acute” crises for example: repeated 
acute crises consisting of marked 
psychological distress that impairs function 
and warrants clinician intervention (e.g., 
occurring once a month or more frequently); 
this we be evaluated by the clinician screener 
 
□ 
□ 
 
 
This subject is      
 eligible / 
 ineligible     for participation in this study. 
 
OnCore Assigned PID: ___ ___ ___ ___ ___ ___ ___ ___  
 
 
 
 
 
 
 
 
Signature of research professional confirming eligibility: _______________________  
 
Date: ___ ___ / ___ ___ / ___ ___ 
 
Signature of Treating Physician:  _____________________________________  
 
Date:  ___ ___ / ___ ___ / ___ ___ 
 
Signature of Principal Investigator**:  _____________________________________  
 
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” 
 
**Principal Investigator signature can be obtained following registration if needed 
 

C a ncer wit hi n a P a n de mic: A Tele me nt al H e alt h I nter ve nti o n Desi g ne d t o A u g me nt Ps yc h ol o gic al 
Resilie nce  a mi dst D u al He alt h T hre ats  
W a k e F or e st B a pti st C o m pr e h e n si v e C a n c er C e nt er  
W F B C C C # 0 1 5 2 0  
 
 
Pr ot o c ol v er si o n d at e 0 5/ 1 4/ 2 1   
  
  
  
  
  
 
P a g e 2 8  of 3 6  
A p pe n di x B – Pr ot oc ol Re gistr ati o n F or m  
 
D E M O G R A P HI C S  
Patie nt: Last Na me: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
First Na me: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
M R N:          _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  D O B ( m m/ d d/ y y): _ _ _ _ _ _ / _ _ _ _ _ _ / _ _ _ _ _ _  
ZI P C O D E
:  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
S E X:   
  Male      Fe male  
Et h nicit y (c h o ose o ne):    His pa nic  
N o n -His pa nic  
Race (c h o ose all t hat 
a p pl y): 
 W HI T E           B L A C K            A SI A N  
 P A CI FI C I S L A N D E R                 N A TI V E A M E RI C A N  
Hei g ht:   _ _ _ _ _ _. _ _ _ i nc hes  
Wei g ht: _ _ _ _ _ _ _ _ _. _ _ _l bs.(act ual)  
S urface Area: _ _ _ _ _ _. _ _ _ m 2   
 
Pri mar y Dia g n osis: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
Date of Dia g n osis: _ _ _ _ _ _ / _ _ _ _ _ _/ _ _ _ _ _ _  
 
Perf or ma nce Stat us: _ _ _  E C O G   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pr ot oc ol Re gistr ar c a n be c o nt act e d by c alli n g 3 3 6 -7 1 3 -6 7 6 7 bet wee n 8: 3 0 A M a n d 4: 0 0 P M, M o n d ay – Fri d ay.  
C o m pete t he eli gi bility c hecklist i n WI S E R a n d t he n give t he c o m plete d Eli gi bility C hecklist a n d Pr ot oc ol Re gistr ati o n F or m m ust be h a n d 
delivere d, f axe d or e -m aile d t o t he re gistr ar at 3 3 6 -7 1 3 -6 7 7 2 or re gistr a @ w ake he alt h.e d u, res pectively. 
P R O T O C O L I N F O R M A TI O N  
Date of Re gistrati o n:  
_ _ _ _ _ _ / _ _ _ _ _ _ / _ _ _ _ _ _  
M D Na me (last) :  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _       
Date pr ot oc ol treat me nt starte d:  
_ _ _ _ _ _ / _ _ _ _ _ _ / _ _ _ _ _ _  
I nf or me d writte n c o nse nt: 
(c o nse nt m ust be si g ne d pri or t o re gistrati o n) 
 Y E S   N O  
 
Date C o nse nt Si g ne d:  
_ _ _ _ _ _ / _ _ _ _ _ _ / _ _ _ _ _ _  
 
PI D # (t o be assi g ne d b y O n C ore ): 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
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Appendix C - Race & Ethnicity Verification Form 
 
 
Thank you so much for helping us to verify your race and ethnicity to ensure the quality of our information. As a 
brief reminder, the information you provide today will be kept confidential. 
 
1. Are you: 
Hispanic or Latino/a 
Not Hispanic or Latino/a 
 
2. What is your race? One or more categories may be selected. 
White or Caucasian 
Black or African American 
American Indian or Alaskan Native 
Asian 
Native Hawaiian or Other Pacific Islander 
Other, Please Specify: ___________________________ 
          
      
 
 
 
 
 
 
 
 
 
Internal use only: 
 
 
 Name: ____________________ MRN#: ____________________  
 
Was the self-reported race and ethnicity of the participant verified at the time of consent? 
Yes        No 
 
Was a discrepancy found?       Yes         No 
         If yes, please provide what is currently indicated in the EMR:  
 
 
Ethnicity: ____________________  
Race: ____________________ 
Additional comments: __________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
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Appendix D Safety and Toxicity Review Committee Serious Adverse Events SOP 
 
 
 
Data and Safety Monitoring 
Committee (DSMC) Serious Adverse 
Event (SAE) Notification SOP 
Date: 02/11/2021 
 
Mandatory DSMC SAE Reporting Requirements in WISER 
This document describes reporting requirements of adverse events from WFBCCC Investigator 
Initiated interventional trials to the Data and Safety Monitoring Committee (DSMC). A trial is 
considered a WFBCCC Investigator Initiated interventional trial if the following criteria are met: 
 
1) The Principal Investigator (PI) of the trial is a member of a department at the Wake Forest 
University Baptist Medical Center. 
2) WFBCCC is considered as the primary contributor to the design, implementation and/or 
monitoring of the trial. 
3) The trial is designated as “Interventional” using the Clinical Research Categories 
definitions provided by the NCI in the Data Table 4 documentation. 
(https://cancercenters.cancer.gov/GrantsFunding/DataGuide#dt4) 
 
There are two distinct types of WFBCCC Investigator Initiated interventional trials based on where 
patient enrollment occurs.  These include: 
 
1) Local WFBCCC Investigator Initiated interventional trials defined as trials where all patients are 
enrolled from one of the WFBCCC sites. These include the main outpatient Cancer Center 
clinics (located in Winston-Salem) as well as WFBCCC affiliate sites located in Bermuda Run 
(Davie Medical Center), Clemmons, Lexington, High Point, or Wilkesboro. 
2) Multi-Center WFBCCC Investigator Initiated interventional trials defined as trials where 
patients are enrolled from other sites in addition to WFBCCC sites.   
There are three types of trials that are included in this category: 
a. Trials sponsored by the NCI Community Oncology Research Program (NCORP) that are 
conducted at multiple sites where the PI is a member of a department at the Wake 
Forest University Baptist Medical Center. 
b. Trials sponsored by Industry that are conducted at multiple sites and the PI is a 
member of a department at the Wake Forest University Baptist Medical Center. 
c. Trials sponsored by WFBCCC that are conducted at multiple sites and the PI is a 
member of a department at the Wake Forest University Baptist Medical Center. 
 
All Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur on any patients enrolled on 
WFBCCC Investigator Initiated Interventional trials must be entered into the WISER system. The only 
exception to this requirement is for patients enrolled on NCORP trials at non- WFBCCC sites. AEs and 
SAEs for NCORP patients enrolled at WFBCCC sites must be entered into the WISER system. Once these 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
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AEs and SAEs are entered in WISER, certain actions must be taken regarding the reporting of specific 
Adverse Events to the DSMC. 
 
 
 
All Adverse Events that occur during protocol intervention (defined below) and are coded as either 1) 
unexpected grade 4, 2) unplanned inpatient hospitalization > 24 hours (regardless of grade), or grade 
5 (death) must be reported to the DSMC using the using the SAE console in WISER. 
 
A research nurse or clinical research coordinator when made aware that an adverse event meets one 
of the above criteria has occurred on a WFBCCC Investigator Initiated interventional trial, is responsible 
for informing a clinical member of the DSMC by phone (or in-person) about the adverse event. The 
nurse/coordinator should contact the treating physician prior to calling the DSMC clinical member to 
obtain all details of the SAE, as well as all associated toxicities to be recorded along with the SAE. In 
addition, this nurse or coordinator is responsible for entering the adverse event information into the 
SAE console in WISER.  Once the adverse event has been entered into the SAE console an email 
informing the entire DSMC will be generated. 
 
THESE REPORTING REQUIREMENTS APPLY TO any staff member on the study team for a WFBCCC 
Institutional Interventional trial. Ultimately, the protocol PI has the primary responsibility for AE 
identification, documentation, grading and assignment of attribution to the investigational 
agent/intervention. However, when an AE event as described above is observed, it is the 
responsibility of the person who observed the event to be sure that it is reported to the DSMC. 
 
What is considered during protocol intervention? 
During protocol intervention is considered to be the time period while a patient is on study treatment or 
during the time period within 30 days of last study treatment (even if patient begins a new (non-study) 
treatment during the 30 days). This window of 30 days should be the standard window to be used in all 
protocols unless a specific scientific rationale is presented to suggest that a shorter window can be used 
to identify events. If it is a trial sponsored by Industry and the sponsor requires a longer window for 
monitoring of SAEs, then the longer window of time specified by the sponsor should be followed. 
 
What is considered as an Unexpected Grade 4 event? 
Any grade 4 event that was not specifically listed as an expected adverse event in the protocol should be 
considered as unexpected. A grade 4 adverse event can be considered to be unexpected if it is an event 
that would not be expected based on the treatment being received or if it is unexpected based on the 
health of the patient. In either case, if there is any uncertainty about whether a grade 4 adverse event is 
expected or unexpected it should be reported to DSMC. 
 
DSMC notification responsibilities of the person (e.g., nurse) handling the reporting/documenting of the 
SAE in WISER: 
1. Make a phone call (or speak in person) to the appropriate clinical member of the DSMC 
according to the schedule as listed below (page if necessary). 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
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2. Enter a new SAE into the SAE module that is located in the Subject>> CRA Console in WISER 
WITHIN 24 HOURS of first knowledge of the event. Information can be entered and saved, but 
the DSMC members will not be notified until a date is entered into the  DSMC Notification Date 
Field. This will ensure that all persons that need to be made aware of the event (i.e., PI, study 
team members and DSMC members) will be notified; remember to file a copy of the 
confirmation. 
3. Document that the appropriate person(s) on the DSMC has been contacted. Indicate the name of 
the DSMC clinician that was contacted and the date and time contacted in the Event Narrative 
field in the SAE console of the particular subject. 
4. Document whether or not the protocol should be suspended based on the discussion with the 
DSMC clinician. This is the major function of the email notification. Enter whether the protocol 
should be suspended in the Event Narrative Field. 
5. Follow up/update the clinical member(s) of DSMC regarding any new developments or 
information obtained during the course of the SAE investigation and reporting process. 
 
Elements needed to complete the SAE form in the Subject Console in WISER (see Screen Shot 3): 
1. Event Date 
2. Reported Date 
3. Reported by 
4. If Grade 5, enter Death Date 
5. If Grade 5, enter Death occurred: within 30 days 
6. Event Narrative: Brief description (include brief clinical history relevant to this event, including 
therapies believed related to event). Begin narrative with the DSMC clinician who was notified and 
Date/Time notified. In addition, state attribution by DSMC clinician as either “Unrelated”, 
“Unlikely”, “Possibly”, “Probably”, or “Definitely”.  Always include the following here: 
i. DSMC clinician name, date/time contacted and comments 
ii. Date of last dose before the event 
iii. Is suspension of the protocol needed? Y/N 
7. Treating Physician comments 
8. PI comments, if available 
9. Protocol Attribution after discussion with DSMC clinician 
10. Outcome (Fatal/Died, Intervention for AE Continues, Migrated AE, Not Recovered/Not Resolved, 
Recovered/Resolved with Sequelae, Recovered/Resolved without Sequelae, Recovering and 
Resolving) 
11. Consent form Change Required? Y/N 
12. SAE Classification *This is required in order for the email notification to be sent* 
13. Adverse Event Details – Enter all details for each AE associated with the SAE. 
a. Course start date 
b. Category 
c. AE Detail 
d. Comments 
e. Grade/Severity 
f. Unexpected Y/N 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
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g. DLT Y/N 
h. Attributions 
i. Action 
j. Therapy 
k. Click ADD to attach the AE Detail to the SAE. 
14. Enter Date Notified DSMC -- *This is required for the email notification to be sent* 
15. Click Submit. The auto-generated notification email will disseminate within 5 minutes. If you do 
not receive an email within 5 minutes, check that you have entered the “Date Notified DSMC” and 
the “SAE Classification”. If these have been entered and the email still has not been received, take 
a screen shot of the SAE in WISER and immediately email it out to all of the DSMC members listed 
in this SOP. In the subject line, indicate that this is a manual transmission of the SAE in lieu of the 
auto-generated email. It is required that a notification goes to the DSMC members immediately so 
that their assessment can be obtained within the 24 hour period requirement. Contact the Cancer 
Center Programmer/Analyst to alert that there is an issue with the auto-generated email. 
 
The Clinical Members of DSMC to Notify by Phone or Page: 
 
Monday 
Tuesday 
Wednesday Thursday 
Friday 
Saturday Sunday 
Lesser 
Hughes 
Goodman 
Reed 
Porosnicu Seegars 
Lesser 
Hughes 
Goodman 
Reed 
Porosnicu 
Seegars 
Lesser 
Hughes 
Goodman 
Reed 
Porosnicu 
Seegars 
Lesser 
Hughes Goodman 
Reed 
Porosnicu 
Seegars 
Lesser 
Hughes Goodman Reed 
Porosnicu 
Seegars 
Lesser 
Hughes 
Goodman 
Reed Porosnicu
Seegars 
Lesser 
Hughes 
Goodman 
Reed 
Porosnicu Seegars 
 
  
 
 
 
 
 
 
 
Definition of Unavailable: 
As a general guideline if the first clinician that is contacted does not respond to the phone call or page 
within 30 minutes, then initiate contact with the next DSMC clinician listed in the table above on the 
particular day the SAE is being reported. Allow up to 30 minutes for the new DSMC clinician to respond to 
a phone call or page before contacting the next member in the table. These times (30 minutes) are a 
general guideline. Best judgment as a clinical research professional should be used giving considerations 
of the time of day, severity of the SAE, and other circumstances as to when it is appropriate to contact 
backup clinicians. If the event occurs near the end of day, then leave messages (voice or email) as 
appropriate and proceed with submitting the DSMC notification form. It is important to take reasonable 
steps and to document that some type of contact has been initiated to one or more of the clinical 
members of DSMC. 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
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DSMC CLINICAN RESPONSIBILITY: 
It is the responsibility of the DSMC clinician to review all reported events, evaluate the events as they are 
reported; and communicate a response to the Investigator, event reporter and the members of DSMC. 
The review will include but not be limited to the information reported; there may be times when 
additional information is needed in order for an assessment to be made and further communication 
directly with the investigator may be warranted. DSMC reserves the right to disagree with the 
Investigator's assessment. If DSMC does not agree with the Investigator, DSMC reserves the right to 
suspend the trial pending further investigation. If there is any immediate danger or harm that could be 
present for a future patient based on the information provided in the DSMC report then an immediate 
suspension of enrollment should be considered. 
 
 
AMENDMENTS TO PREVIOUS REPORTS 
If all pertinent information is unavailable with the initial submission, once the additional information is 
available do not submit a new report. Rather, go to the original email that was sent to the DSMC and 
using that email “reply to all”. Entitle this new email “Amendment for (list date of event and patient ID)” 
this will avoid duplications of the same event. List the additional information being reported. This 
information needs to be entered into WISER as well. To do this, go to the Subject console and click SAEs 
on the left column. Click on the appropriate SAE number that needs updating. Then click Update. This 
will allow additional  information to be added. 
 
 
Acronyms 
AE – Adverse Event 
DSMC-Data and Safety Monitoring Committee 
SAE-Serious Adverse Event 
WFBCCC – Wake Forest Baptist Comprehensive Cancer Center 
NCI-National Cancer Institute 
WISER –Wake Integrated Solution for Enterprise Research 
 
Screen Shots: 
 
The following screen shots come from the SAE Console within the Subject Console in WISER. 
Screen Shot 1: 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological 
Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
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Screen Shot 2:
 

Cancer within a Pandemic: A Telemental Health Intervention Designed to Augment 
Psychological Resilience amidst Dual Health Threats 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC #01520 
 
 
Protocol version date 05/14/21 
 
 
 
 
 
 
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Screen Shot 3: 
 
 
 
Screen Shot 4: