LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer
Phase: NA
Conditions: Cancer Metastatic to Lung
Sponsor: Duke University

Official Title: LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol 
for Patients Living With Metastatic Lung Cancer 
NCT: NCT06464562 
IRB Document Date: 8/27/2025 

Research Abstract
Please type your Research Abstract here:
The Research Abstract should summarize the main points of your study in one paragraph. The following 
guidelines may help you:
1. Purpose and objective (1-2 sentences)
2. Study activities and population group (2-4 sentences)
3. Data analysis and risk/safety issues (1-2 sentences)
LiveWell is an 8-session Dialectical Behavioral Therapy (DBT) Skills Training-based protocol for patients 
living with metastatic lung cancer. The first phase of this K99/R00 study (K99, Aim 1) aims to refine the 
LiveWell intervention protocol (e.g., content) and procedures (e.g., delivery, training, fidelity monitoring). 
Refinement will be guided by preliminary work (i.e., qualitative feedback from participants in the PI’s F32 
study), consultation with an advisory board of interested parties, and the Dynamic Sustainability 
Framework from implementation science. We will conduct user testing (n=10) of the refined protocol. Data 
collected from user testers will be analyzed using rapid analysis and used to iteratively refine the LiveWell 
protocol and procedures until unanimously approved by the advisory board. The standardized LiveWell 
protocol and procedures produced by this K99 study will be used for the future R00 trial. The risks to user 
testers are minimal.
Research Summary
State your primary study objectives
Aim 1 (K99): To refine and user test the LiveWell protocol and procedures.
State your secondary study objectives

N/A
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This is the regular (generic) research summary template which is required  for all regular applications (unless 
your protocol fits under the other research summary templates in this category).  Use of these instructions is 
helpful for ensuring that the research summary contains all necessary elements.
Standard Research Summary
Purpose of the Study
Objectives & hypotheses to be tested
Survival rates are improving for patients with metastatic lung cancer (i.e., metavivors) due to therapeutic 
advances. However, living longer with metastatic cancer presents significant challenges. Most metavivors 
will ultimately die of cancer and must navigate the duality of 
. As stated by one 
living while dying
metavivor, “I feel like a ticking time bomb...I’m scared to be hopeful...I don’t know how to live with 
cancer.” Within this challenging emotional context of balancing hope with uncertainty, metavivors must 
also learn to manage persistent, burdensome symptoms (i.e., fatigue, dyspnea, pain). Metavivors have 
difficulty navigating these challenges and experience high psychological distress (i.e., depressive 
symptoms, anxiety, illness non-acceptance), high symptom burden (i.e., fatigue, dyspnea, pain) and poor 
overall quality of life. 
Psychosocial interventions have the potential to improve psychological distress, symptom burden, and 
quality of life in metavivors. However, existing intervention paradigms are not designed to address 
metavivors’ diverse, fluctuating emotional needs. Metavivors require strategies that can help them to 
navigate the emotional turbulence of living with and managing metastatic disease. Emotion regulation (i.
e., the ability to monitor and manage emotional experiences and responses) is a promising transdiagnostic 
intervention target to improve metavivors’ ability to cope with the challenges of 
.
living while dying
Dialectical behavioral therapy (DBT) is an evidence-based psychotherapy that targets emotion regulation. 
DBT Skills Training teaches core skills (e.g., mindfulness, distress tolerance, emotion regulation, 
interpersonal effectiveness) to facilitate both acceptance of reality as it is 
 behavior change. Balancing 
and
acceptance and change is exceptionally salient for metavivors, as there are emotionally demanding 
circumstances to accept (e.g., uncertainty about the future, physical changes, life not looking as planned), 
 change (e.g., illness-related thoughts, symptom management behaviors) to reduce psychological 
and
distress and symptom burden, and improve quality of life. DBT Skills Training can help metavivors to live 
 
well, with lung cancer.
Dr. Hyland (PI) conducted a Phase IB/IIA study (1F32CA265058) to adapt (e.g., dose, delivery, content) 
and pilot test a DBT Skills Training intervention for lung cancer metavivors. This is the first NCI-funded 
study to examine DBT Skills Training in cancer patients. Qualitative interviews with metavivors and their 
providers confirmed that DBT skills are highly relevant and needed. One metavivior noted, “these skills are 
as important and valuable as treatment”. Interviews directly informed and produced LiveWell, an 8-session 
adapted DBT Skills Training protocol delivered one-on-one via telehealth. Qualitative data and a single-arm 
pilot (N=30) support proof-of-concept. Building on preliminary data and aligned with the ORBIT behavioral 
intervention development model, the current study aims to iteratively refine and user test the LiveWell 
protocol and procedures.
Aim 1 (K99): To refine the LiveWell protocol and procedures. Refine the LiveWell protocol (e.g., 
content) and procedures (e.g., delivery, training, fidelity monitoring). Refinement will be guided by: 1) 
preliminary work (i.e., qualitative feedback from F32 participants), 2) The Dynamic Sustainability 
Framework from implementation science, and 3) consultation with an advisory board composed of 
interested parties (2 lung cancer metavivors, 1 thoracic oncologist, 1 behavioral clinical trial expert, 1 
implementation scientist, 1 DBT expert, 1 member of cancer center leadership). We will conduct user 
testing (N=10) of the refined protocol and integrate feedback. 
The iterative refinement process will produce a standardized LiveWell protocol and procedures for the 
independent R00 phase, a Phase IIB randomized pilot trial to examine feasibility, acceptability, and 

outcome patterns of LiveWell and Enhanced Usual Care (separate, future IRB application). If successful, 
Livewell will improve metavivor quality of life and provide a promising psychosocial intervention paradigm 
for other groups of metavivors and patients living with chronic illness.
Background & Significance
Should support the scientific aims of the research
Lung Cancer Metavivors Face Unique Challenges. There are over 620,000 people living with 
metastatic lung, breast, colorectal, or bladder cancer or melanoma in the United States today.
With the 
35 
advent of new therapies, metastatic cancer is often treatable, but not curable, and patients may live for 
years even after the disease has spread.
 However, most patients with metastatic cancer will ultimately 
36
die of cancer and must navigate the difficult duality of “living while dying”. While cancer survivorship 
encompasses all patients from the time of diagnosis, the needs of survivors living with metastatic disease 
(i.e., metavivors) likely differ from those of patients treated with curative intent or at the end of life. A 
meta-analysis of unmet needs in patients living with advanced cancer found that patients endorsed unmet 
emotional and psychological needs (e.g., anxiety, depression, uncertainty about the future, fear of death), 
physical needs (symptoms (i.e., fatigue, pain, dyspnea), “not being able to do the things I used to do”) 
and informational needs (i.e., “being informed about things you can do to help yourself”).
Patients with 
37 
lung cancer, in particular, endorse higher psychological distress and physical symptom burden compared 
to other disease types.
 Given the high number of unmet needs, high rates of distress, and high 
38-41
symptom burden, it is unsurprising that patients living with metastatic lung cancer endorse poor quality of 
life and are at elevated risk for worse overall health outcomes.
As medical advances continue to 
42-44 
extend life expectancy, there is a need for supportive interventions designed to meet the needs of lung 
cancer metavivors to ensure that these patients are not only living longer, but living well.
Psychosocial Interventions Have Not Been Designed for Metavivors. Literature supports the 
efficacy of psychosocial interventions to reduce psychological distress and symptom burden and improve 
quality of life and health outcomes in cancer survivors.
 However, metavivors are under-researched in 
45-48
the psychosocial oncology literature.
 Most psychosocial interventions are designed for survivors treated 
49
with curative intent, or conversely, for patients facing end of life. While symptoms of distress typically 
decrease with time since diagnosis in cancer survivors, research suggests that trajectories of distress in 
metavivors are different, such that anxiety, post-traumatic stress, and fear of disease progression persist 
years after diagnosis.
 These emotional challenges are understandable, as metavivors must balance 
50-53
hope for a positive treatment response and disease control with significant uncertainty about the future, 
and providers’ ability to prognosticate who will respond well to newer therapies and for how long is limited.
Early palliative care can help to establish goals of care and provide symptom management and general 
support to patients with advanced disease, which can improve quality of life.
 However, these services 
52
are not designed to address the emotional challenges of living extended periods of time with metastatic 
cancer. It is critical to identify interventions that can specifically address the unmet psychosocial needs of 
metavivors because, as one lung cancer metavivor noted, “the emotional effects of treatment are much 
 
worse than the physical”.
Dialectical Behavioral Therapy Skills Training: A Promising Psychosocial Intervention for 
Metavivors. Dialectical behavioral therapy (DBT) is an evidence-based treatment that focuses on the 
acquisition of skills to optimize emotion regulation and promote a “life worth living.”
 DBT is a third-
54,55
wave cognitive behavioral therapy (CBT) that integrates change-oriented strategies found in traditional 
CBT (e.g., change dysfunctional cognitions, unhelpful behaviors), with acceptance-focused strategies (e.g., 
mindfulness of the present moment, accept reality as it is), and dialectical thinking. Dialectical thinking is 
the ability to hold onto two seemingly opposite things as true at the same time, like living and dying or 
acceptance and change. Whereas traditional CBT protocols emphasize change (e.g., how we think, feel, 
act) as a strategy to improve outcomes, third-wave therapies, including DBT, acceptance and commitment 
therapy (ACT), and mindfulness-based treatments, integrate acceptance-focused strategies (e.g., 
accepting things as they are).
 Both DBT and ACT teach patients to accept things that they cannot 
56
change. This is extremely validating and important for patients with problems that cannot be changed (e.
g., a metastatic cancer diagnosis). However, whereas ACT encourages patients to choose to act according 
to their values regardless of emotional or physical symptom burden, DBT includes several unique 
ingredients that may be particularly valuable to lung cancer metavivors: 1) DBT teaches strategies to 
change emotions and physical symptoms (when appropriate), and 2) DBT addresses interpersonal 
effectiveness and communication skills, which metavivors identify as important (e.g., communicating 
wants and needs with loved ones, asking the medical team questions). While ACT has been widely adopted 

for patients with chronic illness,
 research on DBT in chronic physical illness has been limited, likely 
57,58
due to 1) inaccurate perceptions of DBT as a lengthy treatment for psychopathology, 2) siloes in 
treatment, and relatedly, 3) a lack of providers with adequate training to translate DBT into health settings.
DBT Skills Training is a component of DBT treatment that may offer particular benefit as it teaches a 
compendium of easy-to-use strategies from across psychology (mindfulness, distress tolerance, emotion 
regulation, interpersonal effectiveness). The modular nature of DBT Skills Training and focus on a 
transdiagnostic process (i.e., emotion regulation) make it broadly applicable to various stressors and 
symptoms and suitable for adaptation.
 DBT Skills Training has been adapted for a variety of populations 
59
(e.g., people with anxiety, depression, PTSD, substance abuse disorders, eating disorders, chronic pain) 
and demonstrated efficacy in improving emotion regulation, distress, symptom coping and acceptance, 
quality of life, and other important health outcomes.
 
60-63 However, applications of DBT Skills Training in 
cancer patients have been limited.
Emotion Regulation in Cancer: Emerging Evidence. Emotion regulation, the process by which 
individuals monitor and manage their emotional experiences and responses, may be a mechanism by 
which DBT Skills Training impacts health outcomes.
 Research suggests that high negative emotionality 
64
and greater use of maladaptive emotion regulation strategies (e.g., suppression, avoidance) is linked to 
greater psychological distress and worse overall health outcomes (e.g., disease, death).
 Conversely, 
 
65,66
greater use of adaptive emotion regulation strategies (e.g., cognitive reappraisal, acceptance) has been 
associated with greater emotional vitality, greater symptom tolerance, greater physical vigor and better 
immune functioning.
 Taken together, changes in emotion regulation may be a mechanism by which 
65,67
DBT Skills Training reduces metavivor psychological distress and symptom burden and improves quality of 
life.
However, research on interventions to improve emotion regulation in cancer patients has been 
65,68-70 
limited. 
The Current Project: LiveWell. We recognized the exceptional fit of DBT Skills Training for lung cancer 
metavivors and conducted the first NCI-funded study to examine DBT Skills Training in cancer 
(1F32CA265058). We adapted DBT Skills Training for lung cancer metavivors (e.g., dose, delivery format, 
materials) creating LiveWell, an eight-session adapted DBT Skills Training protocol delivered one-on-one 
. The current study will allow for timely progression of intervention development and testing 
via telehealth
aligned with the ORBIT model for behavioral treatment development.
 In the current study (K99 phase), 
71
we will use an iterative, collaborative approach to refine the LiveWell study protocol and procedures (Aim 
1). 
Design & Procedures
Describe the study, providing details regarding the study intervention (drug, device, physical 
procedures, manipulation of the subject or the subject’s environment, etc.). Discuss justifications for 
placebo control, discontinuation or delay of standard therapies, and washout periods if applicable. 
Identify procedures, tests and interventions performed exclusively for research purposes or more 
frequently than standard of care. Include alternative therapies, concurrent therapies discontinued per 
protocol, risk benefit ratio, and use of tissue/specimens. Discuss monitoring during washout periods if 
applicable. Include brief description of follow-up, if any.
Intervention. LiveWell is an 8-session protocol of Dialectical Behavioral Therapy Skills Training, adapted 
specifically for patients with metastatic lung cancer. Sessions are 45-60 minutes in length and are 
delivered approximately weekly, one-on-one, via telehealth. Participants learn concrete, easy-to-use skills 
to: 1) tune into the present moment, and how they are thinking and feeling (
), understand 
mindfulness
emotions, how to change them, and how to experience more positive feelings (
), 
emotion regulation
tolerate distressing emotions and symptoms (e.g., fatigue, pain, dyspnea) and to accept reality as it is (dist
, and tools to communicate wants and needs effectively with others (
ress tolerance)
interpersonal 
). ). An overview the protocol is provided in the table below. The goal is to teach patients 
effectiveness
skills to live well, 
 metastatic cancer. All sessions follow a standardized structure that is customary in 
with
skills training and grounded in social cognitive theory: 1) engage in a brief mindfulness experiential 
exercise; 2) review homework to reinforce application of skills taught the previous week; 3) facilitate 
learning of new skills through a) skill acquisition (modeling, teaching), b) strengthening (practice, role 
play), and c) generalization (assign home practice to promote flexible use in the real world); 4) closing 
ritual (dialectic of the week).
 
91

Study Overview. The aim of the current study is to refine the LiveWell intervention protocol (e.g., 
content) and procedures (e.g., delivery, training, fidelity monitoring). Refinement will be guided by 
preliminary work (i.e., qualitative feedback from PI’s fellowship study pilot participants), consultation with 
an advisory board of interested parties, and the Dynamic Sustainability Framework from implementation 
science. We will conduct user testing (n=10) of the refined protocol and integrate feedback. The iterative 
refinement process and elements are described below. This will produce a standardized LiveWell protocol 
and procedures that will be tested in the R00 trial (separate, future IRB application).
Advisory board: The advisory board will include members of interested parties with expertise relevant to 
the project, including a thoracic oncologist (Dr. Thomas Stinchcombe), a behavioral clinical trial expert (Dr. 
Frank Keefe), an implementation scientist (Dr. Leah Zullig), a DBT expert (Dr. Andrada Neacsiu), a 
member of cancer center leadership (Dr. Kevin Oeffinger) and two lung cancer metavivors. The two patient 
advisors will be lung cancer metavivors who previously participated in the PI's F32 fellowship study 
(Pro00108640). The advisory board will convene for bi-monthly, one-hour meetings. These meets may be 
held virtually or in-person, depending on board preference. The purpose of these meetings is to discuss 
refinement of the LiveWell intervention protocol and procedures and to review and provide feedback on 
iterations of the protocol and procedures. Minutes will be circulated following each meeting. Refinements 
will be made by the PI in between meetings. A detailed log of changes made will be maintained. This 
process will continue until the protocol and procedures are unanimously approved by the board.
Preliminary work: All participants in the PI’s F32 fellowship study (Pro00108640), which tested LiveWell 
using a single-arm pilot trial design, were invited to participate in a qualitative exit interview to provide 
feedback on the LiveWell intervention, study procedures, and their overall experience in the program. Exit 
interviews were audio recorded and will be transcribed and analyzed using rapid analysis. Summaries of 
this data will be circulated to advisory board members and discussed at the initial board meeting to inform 
the first round of intervention refinement.
Implementation Science: The proposed project will leverage several pillars of the Dynamic Sustainability 
Framework, including 1) ongoing adaptation with a focus on fit, 2) ongoing stakeholder involvement, 3) 
standardization and streamlining, and 4) use of practical, relevant measures. As described above, exit 
interview data from the F32 fellowship study will help us to identify content that participants identify as 1) 
critical, 2) missing, and 3) unnecessary, and provide information about the feasibility of LiveWell in its 
current form. We will emphasize standardization of LiveWell content delivery and study procedures. We 
will ensure standardization by 1) automating some content (e.g., developing videos to explain key study 
concepts, recorded mindfulness e-library), 2) developing a protocol for interventionist training, 3) 
establishing clear procedures for intervention delivery (e.g., refined interventionist manual) and study 
operations (e.g., SOPs), and 4) developing a strategy to thoroughly assess fidelity. The advisory board will 
also review the assessment battery to ensure measures are as concise as possible and that they clearly 
reflect outcomes of interest. The baseline (A1) and post-treatment (A2) assessments will be uploaded with 
a future amendment.
User testers: Once a revised LiveWell protocol and procedures have been approved by the advisory 
board, we will conduct user testing. User testers (n=10) will meet eligibility criteria and be identified using 
the same procedures for the future R00 trial 
User testers will complete the 
(see Participants section). 
baseline assessment (A1), then receive the refined LiveWell intervention protocol. Following each session, 
participants will complete Likert scale ratings of perceived usefulness of the material, applicability to the 
patients’ needs, and overall session quality. Following intervention completion, user testers will complete a 
post-treatment assessment (A2) consisting of self-reported outcome measures and additional Likert scale 
ratings of the acceptability of LiveWell procedures (i.e., recruitment and enrollment, assessment 

procedures). User testers will complete an in-depth qualitative interview to discuss their experience with 
the program and to provide feedback. This will include additional questions about the acceptability, 
feasibility, and enjoyableness of the refined intervention, particularly the refined content (e.g., relevance, 
usefulness) and its delivery (e.g., recorded videos). Exit interviews will be transcribed and evaluated using 
a rapid analysis approach to rapidly inform further intervention refinement. User tester feedback will be 
presented during advisory board meetings and integrated. 
Selection of Subjects
List inclusion/exclusion criteria and how subjects will be identified.
Participants
Patient advisory board members will be N=2 lung cancer metavivors who previously participated in the PI's 
F32 fellowship study. Patient advisors hold unique knowledge and expertise as persons with lived 
experience with the disease, and personal experience participating in the LiveWell program. Lung cancer 
metavivors will be recruited from Duke Cancer Institute (DCI) using procedures listed under Subject 
 
Recruitment.
Eligible patients will: 
1) be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
2) have completed the LiveWell program as a study participant on Pro00108640, the PI's F32 fellowship
study, and expressed a willingness to be contacted for future research
5) be able to understand, speak, and read English
6) be able to provide informed consent.
Exclusion criteria include: 
1) under the direct care of the advisory board thoracic oncologist, Dr. Thomas Stinchcombe. This will
ensure there is no compromising the patient/provider relationship.
Recruitment procedures are described in detail in the “Subject Recruitment” section.
User Testers will be N=10 lung cancer metavivors who meet eligibility criteria for the proposed R00 trial Lu
. 
ng cancer metavivors will be recruited from Duke Cancer Institute (DCI) and Duke Cancer Center (Raleigh, 
NC), using procedures listed under 
 
Subject Recruitment.
Eligible patients will: 
1) be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
2) be undergoing lung cancer treatment with non-curative intent
3) endorse 
3 out of 10 on the NCCN distress thermometer over the past week
>
4) be 
 18 years of age
>
5) be able to understand, speak, and read English
6) be able to provide informed consent.
Exclusion criteria include: 
1) reported or suspected cognitive impairment
2) presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or
treating oncologist
3) expected survival <6 months.
At least four user testers will be recruited from each of the study sites (e.g., Duke Cancer Center Clinics in 
Durham, Raleigh). Recruitment procedures are described in detail in the “Subject Recruitment” section.
Subject Recruitment and Compensation
Describe recruitment procedures, including what method(s) will be used, when the study will be 
introduced to potential participants and by whom.  If any follow-up contact is planned, describe the 
proposed method and timing. Describe how you will ensure that subject selection is equitable and all 
relevant demographic groups have access to study participation (per 45 CFR 46.111(a) (3)). Include 
information about how many DUHS participants will be recruited. If participants are to be compensated 
and/or reimbursed, provide specific prorated amounts to be provided for expenses such as travel and
/or lost wages, and/or for inducement to participate.

Patient Advisory Board Members
Subject Recruitment: The research team will recruit 2 patient advisory board members from the pool of 
study participants from the PI's F32 study, Pro00108640. During this trial, participants were asked if they 
would be open to being contacted for future research. We will contact patients who agreed to being 
contacted for future research, who are not patients of the thoracic oncologist on the advisory board, Dr. 
Thomas Stinchcombe. Patients will be contacted by highly trained study staff via telephone, no more than 
three times, to assess interest in advisory board membership. We will contact participants until two have 
been identified as eligible and interested. If a patient is interested when contact is made with a study team 
member, they will be provided with information about the advisory board and the K99 study, including the 
purpose, requirements, and time commitment. Eligible patients who wish to participate as advisory board 
members and enroll in the study will complete an electronic consent form via REDCap or, if preferred, be 
mailed a hard copy consent form to be reviewed by telephone, executed, and returned by mail. Consent 
procedures may also be completed in-person at the cancer center. In-person visits will be scheduled at a 
time that is convenient for the patient. In all cases, a member of the study team will review consent in a 
private space and answer any questions that the potential participant may have. Informed consent will be 
documented by signature on an IRB-approved consent form. Remote, direct-to-patient recruitment 
approaches have allowed the PI and research team to efficiently reach more patients while reducing 
numerous obstacles encountered with methods that require physician time and clinic resources (e.g., 
space). 
Compensation: Patient advisors will be compensated $200 quarterly for one year for their participation. 
Compensation will be in service of patient board members' attendance at in approximately bi-monthly, 1-
hour advisory board meetings, preparation time to review materials prior to and following each meeting, 
and travel to and from meetings, if held in-person (potential total compensation=$800).
User Testers
Subject Recruitment: The research team will recruit 10 user testers using the same direct-to-patient 
recruitment method that has been successful in PI’s F32 project with the same patient population. This 
includes using DEDUCE and PACE (Protected Analytics Computing Environment) software to identify 
patients who meet initial eligibility criteria. Under a HIPAA waiver, study staff will query for patients that 
meet study eligibility criteria, then screen the Duke electronic medical record (EMR) to identify potentially 
eligible patients on a weekly basis. After a careful chart review to verify initial eligibility (e.g., age 
18 
>
years, diagnosis is metastatic non-small cell lung cancer, receiving treatment with non-curative intent), 
study staff will mail or email a recruitment letter to potential participants. The letter will state that the 
patient may be eligible to participate in a research study evaluating a skills training intervention (i.e., 
LiveWell) for patients with advanced lung cancer. The letter includes a number to call if the patient is 
interested in learning more about the study (or would like to opt out) and explains that a study staff 
member will contact them about the study. Patients may also be referred to the study by their medical 
providers. The medical team will introduce the study, and, if interested, the PI or a study staff member will 
contact the patient to further describe the study and discuss questions and/or concerns.
Patients will be contacted by highly trained study staff to assess interest. All patients who meet initial 
eligibility criteria will be contacted unless they opt out. Consistent with Duke’s direct-to-patient 
recruitment guidelines, patients will be contacted a maximum of three times. These contact attempts 
include telephone calls (using an IRB-approved telephone script), recruitment emails (using an IRB-
approved email template), and/or in-person visits to the outpatient thoracic oncology clinic(s). If a patient 
is interested when contact is made with a study team member, they will be provided with information 
about the study, including the purpose, requirements, and time commitment. Interested patients will 
complete a brief screening interview (e.g., NCCN distress rating), either via phone, Zoom, or in person 
(based on patient preference) to confirm full eligibility. Those who do not pass the screening interview will 
be provided with a list of free resources available through the institution (e.g., individual and couple 
counseling through the Duke Cancer Patient Support Program, financial support). Eligible patients who 
wish to enroll in the study will complete an electronic consent form via REDCap or, if preferred, be mailed 
a hard copy consent form to be reviewed by telephone, executed, and returned by mail. Consent 
procedures may also be completed in-person at the cancer center. In-person visits will be scheduled at a 
time that is convenient for the patient. In all cases, a member of the study team will review consent in a 
private space and answer any questions that the potential participant may have. Informed consent will be 
documented by signature on an IRB-approved consent form. Remote, direct-to-patient recruitment 
approaches have allowed the PI and research team to efficiently reach more patients while reducing 
numerous obstacles encountered with methods that require physician time and clinic resources (e.g., 
space). 
Compensation: User testers participants will be compensated $40 for each self-report assessment and 
$30 for the exit interview (potential total compensation=$40 baseline assessment, $40 post-intervention 
assessment, $30 exit interview=$110).
Consent Process

Complete the consent section in the iRIS Submission Form.
Subject’s Capacity to Give Legally Effective Consent
If subjects who do not have the capacity to give legally effective consent are included, describe how 
diminished capacity will be assessed. Will a periodic reassessment occur? If so, when? Will the subject 
be consented if the decisional capacity improves?
Cognitive impairment will be assessed via medical record review, or by a baseline Folstein Mini-Mental 
Status Examination of <25. If patient is cognitively impaired, they will be excluded from the study per 
study protocol.
Study Interventions
If not already presented in the Design & Procedures section, describe study-related treatment or use of 
an investigational drug or biologic (with dosages), or device, or use of another form of intervention (i.
e., either physical procedures or manipulation of the subject or the subject’s environment) for research 
purposes.
The LiveWell Intervention and procedures that will be used to refine the intervention are described above. 
Risk/Benefit Assessment
Include a thorough description of how risks and discomforts will be minimized (per 45 CFR 46.111(a) (1 
and 2)). Consider physical, psychological, legal, economic and social risks as applicable. If vulnerable 
populations are to be included (such as children, pregnant individuals, imprisoned persons or 
cognitively impaired adults), what special precautions will be used to minimize risks to these subjects? 
Also identify what available alternatives the person has if he/she chooses not to participate in the 
study. Describe the possible benefits to the subject. What is the importance of the knowledge expected 
to result from the research?
No adverse events are anticipated. Study participation is voluntary and participants can withdraw at any 
time. The risks associated with this study are minimal and rare. The potential risks are associated with (1) 
confidentiality related to videoconferencing, and self-report data; and (2) emotional upset due to 
questioning about thoughts, feelings, and personal history of cancer when completing intervention sessions 
and assessments. 
First, breach of confidentiality is a possible risk. This will be clearly stated in the consent form. All efforts 
will be made for confidentiality to be maintained by using study ID numbers to identify participants’ 
research records participant names to study ID numbers will be stored separately from data and research 
records in a password- protected database. All paper research records (e.g., paper consent and 
assessment documents) will be kept in a locked file cabinet in the PI’s locked office in the PPTRP laboratory 
housed within the Department of Psychiatry and Behavioral Sciences’ Clinical Research Facility at the Duke 
North Pavilion (2400 Pratt Street, 7
 Floor, Durham, NC, 27705). There is some risk of loss of 
th
confidentiality inherent to the use of videoconferencing to conduct the study intervention sessions. To 
protect patient privacy, we will use Zoom videoconferencing, which has standard internationally-
recognized and accepted encryption algorithms. Only approved research team members will have access 
to the research records. All research team members will be required to complete the DUMC IRB online 
training course (i.e., Protecting Research Subjects) as well as human research subjects’ protection training 
and certification through the Collaborative Institutional Training Initiative (CITI) program, both of which 
address confidentiality.
Two password-protected databases will be used for this study to ensure confidentiality. First, a tracking 
database will be used for recruitment and follow-up. This database will house information related to 
tracking the participants in the study, such as phone numbers and addresses. Identifying information will 
be kept separate from research records. No medically sensitive or outcome data will be stored in this 
database. This database will also track non-participants (i.e., those who have declined participation) only 

to the bare minimum to ensure that they are not contacted again about participation. At the end of the 
study, all identifiable data of non-participants will be deleted. Tracking data on participants will be retained 
for the usual required period. Second, all study data (i.e., self-report assessment data) will be stored in a 
separate password-protected REDCap database without any personal identifiers. Data in this database will 
be derived from patients’ direct input into the electronic patient reported outcomes system which is an 
online survey system; data entered into this system is stored on a secure server housed behind the DUMC 
firewall. Only a unique study ID number will link the electronic data to the study data file. The tracking 
data and study data will be stored in a file on a secure DUMC Psychiatry server which can only be accessed 
by research team members. Access to the Duke network requires a password-protected, 128-bit encrypted 
virtual private network connection provided by Cisco systems.
Second, participants will be asked about their thoughts and feelings regarding cancer diagnosis, treatment, 
and symptoms; thus, it is possible they may experience psychological distress. The psychological risk 
associated with answering questions is expected to be minimal. Although some participants may find 
certain questions or topics to be upsetting, heightened awareness of psychosocial needs may be the first 
step in resolving these concerns. If a participant reports significant distress during study participation, the 
research team will consult with the PI, who is a licensed clinical psychologist. If the participant requires 
additional treatment outside the context of the study, the PI will work with the mentoring team to initiate 
an appropriate referral. Patients with cancer often report benefits from participating in psychosocial 
research. Thus, the risk of psychological distress is minimal and these safeguards should be adequate. The 
benefits to society could include increased knowledge of skill-based strategies that can help to meet the 
needs of lung cancer metavivors.
Costs to the Subject
Describe and justify any costs that the subject will incur as a result of participation; ordinarily, subjects 
should not be expected to pay for research without receiving direct benefit.
Patient advisory board members may incur costs from traveling to and from any meetings that are held in-
person. It is estimated that the majority of meetings will be held virtually, with a potential for 1-2 
meetings in-person. Patient advisors will receive quarterly compensation that would cover such costs plus 
their time.
There is no cost to the user testers. 
Data Management, Analysis and Statistical Considerations
Describe endpoints and power calculations. Provide a detailed description of how study data will be 
analyzed, including statistical methods used, and how ineligible subjects will be handled and which 
subjects will be included for analysis. Include planned sample size justification. Provide estimated time 
to target accrual and accrual rate. Describe interim analysis including plans to stop accrual during 
monitoring. Phase I studies, include dose escalation schema and criteria for dose escalation with 
definition of MTD and DLT.  
For external collaborators/personnel who are 
 in the research but are handling de-
NOT ENGAGED
identified or a limited data set of 
 data, include their name, role and a description of the data.
Duke
Data Collection.
Quantitative Data: User testers with complete assessments at baseline and post-treatment and provide 
feedback on questionnaire length and acceptability. User tester survey data is being collected to evaluate 
the assessment process and no formal statistical analysis will be done with this outcome data. User testers 
will also provide Likert scale ratings (1-5) to assess intervention content relevance and enjoyableness, 
following each session and at intervention completion. This data will be summarized using descriptive 
statistics (means, frequencies) and presented to the advisory board to guide refinement.
Qualitative Data: User testers will participate in in-depth interviews to obtain feedback on the LiveWell 
protocol and procedures (e.g., intervention content, presentation). Interviews will be audio recorded and 
transcribed verbatim. Rapid analysis will be used to analyze qualitative interview data from user testers. 
Findings from rapid analysis will be summarized and used by the PI and advisory board to guide iterative 
intervention refinement. 
Data Management. Participant identifying information will be stored in a secure study database. It will 
not be stored with questionnaire or interview data to protect patient confidentiality. External collaborator 
(and prior study PI) Kelly Hyland will have access to non-identifiable research data in order to collaborate 

as a contributing author on papers and presentations. This non-identifiable data will be shared with Kelly 
Hyland through Duke Box. No data will be shared outside of Duke until any and all necessary agreements 
are fully executed.
Statistical Considerations. Literature suggests that 85% of usability problems can be reliably identified 
in 5 user testers. However, iterative user testing may require more testers, and if conducting research at 
multiple sites, it can be beneficial to conduct testing with 3-5 people per site. Given this, we will use 10 
user testers. Given this, we will recruit 10 user testers over 4 months. 
Analytic Approach. We will use several metrics to signal completion of Aim 1, and readiness to progress 
to the next phase (R00 study). Recurrent themes identified in user tester exit interviews will inform 
adjustments to LiveWell content and procedures. Quantitative data will include Likert scale ratings of 
feasibility, acceptability, and enjoyableness of the LiveWell intervention and procedures. This information 
will be reviewed in consultation with the advisory board and adjustments will be made accordingly. 
Potential adjustments include: updates to recruitment or other operating procedures, changes in the self-
report battery based on user tester feedback (e.g., relevance, length), and changes in intervention 
delivery (e.g., session length, content). We will iteratively refine the LiveWell protocol and procedures until 
unanimously approved by the advisory board. The data collected in Aim 1 does not meet the NIH definition 
of “scientific data” and is considered preliminary.
Data & Safety Monitoring
Summarize safety concerns, and describe the methods to monitor research subjects and their data to 
ensure their safety, including who will monitor the data, and the frequency of such monitoring. If a 
data monitoring committee will be used, describe its operation, including stopping rules and frequency 
of review, and if it is independent of the sponsor (per 45 CFR 46.111(a) (6)).
The proposed study carries minimal risk. There are not physical or side effects involved in taking part in 
this study. The protocol does not use an investigational drug, procedure, or device. 
Data obtained from participants will include information from medical chart review and self-report 
measures. The PI (Dr. Somers), mentors (Drs. Neasciu and Zullig, co-mentors), and collaborators (Drs. 
Stinchcombe, Samsa) consider the secure and ethical management of participant information and data as 
a key priority. Best practices for data management and confidentiality will be observed.
All participants enrolled in the study will continue to receive their usual medical care during the course of 
the study and be informed that choosing to participate in the study will in no way impact the medical 
treatment they receive at the Duke University Medical Center (DUMC). All enrolled participants will 
continue to be monitored by their physicians at the Duke Cancer Institute (DCI) throughout the duration of 
the proposed study; thus participants’ physicians (e.g., oncologists) will provide usual and ongoing 
monitoring of their overall medical status. If a health concern is identified during contact with study staff, 
the participants’ treating oncologist will be contacted, and appropriate referrals for medical treatment will 
be provided to participants. All research personnel who have direct contact with participants will be trained 
to observe and report any adverse events. The PI will report any adverse event to DUMC Institutional 
Review Board (IRB) in real time. An adverse event is defined as any untoward medical event occurring 
. A serious adverse event is 
during the clinical evaluation, which is causally related to the study protocol
defined as any event which results in death, is immediately life threatening, results in persistent or 
significant disability/incapacity, results in patient hospitalization, or is serious for any other reason 
.
representing significant hazard
Potential Risks: Risks associated with the proposed study are minimal and rare. Psychological risks 
include anxiety or distress due to questioning about thoughts, feelings, and personal/family history of 
cancer. There is the possibility of a breach of confidentiality due to the use of mailing of information and 
technology. The consent form will address this possibility. All efforts will be made for confidentiality to be 
maintained by using case numbers to identify participants’ research records and by having a limited 
number of individuals with access to identifying information. Identifying information will be kept separate 
from research records. All research records will be kept in a locked file cabinet and password protected 
computer files. Only the PI
and other trained staff will have access to the research records. To ensure that there are no changes in 
potential risk during the course of the study and that confidentiality is maintained the PI and sponsors will 
implement a Data and Safety Monitoring Plan.
Data and Safety Monitoring: We will appoint two data safety officers. One data safety officer will be a 
physician (i.e., MD) who is not associated with the study. The appointed MD data safety officer will have 
thorough experience with clinical trial research and an advanced understanding of adverse events and 
their reporting. The other data safety officer will be a senior investigator (i.e. PhD) who has experience 

with clinical trial research and expertise in behavioral oncology research. Responsibilities of the data safety 
offers will include: 1) attend an annual Data and Safety Monitoring Meeting convened by the PI; 2) 
become familiar with the research protocol and plans for data and safety monitoring; 3) review accrual, 
attrition, adverse events, and protocol compliance; 4) review major proposed modifications to the study 
prior to their implementation (e.g., termination, significantly altering a study arm, etc.); and 5) provide 
relevant recommendations related to continuing, changing, or terminating the study. All adverse events 
will be reported to IRB and data safety officers in real time. Given the low risk nature of the study, the 
data and safety monitoring committee will convene at least annually.
Protection Against Risk: All data will be stored on a secure server with multiple backups created 
regularly. All interactions with study participants will be under the direction of three licensed clinical 
psychologists including Dr. Hyland (PI), Dr. Somers, and Dr. Neacsiu. Audio recordings of intervention 
sessions with participants will be obtained and reviewed to ensure fidelity of intervention delivery and that 
the interventionists are providing effective, ethical treatment. As a licensed and practicing clinical 
psychologist, the PI has experience with distressed patients with chronic disease. If a participant shows 
signs of experiencing high levels of physical or emotional distress that need to be addressed outside the 
context of this trial, the PI will work directly with the participant to move forward in a way that is in the 
participant’s best interest. No participant will be kept in the trial if they are experiencing increased, 
extreme distress that requires a higher level of clinical management. Study staff will be carefully trained to 
monitor participants’ psychological status and will report to the PI when increased emotional distress is 
identified. The PI will work directly with the Cancer Patient Support Program at the DCI to place 
appropriate referrals for participants reporting increased emotional distress. Drs. Hyland and Somers are 
integrated into the Cancer Patient Support Program at the DCI and have experience referring cancer 
patients who are distressed to appropriate psychosocial or psychiatric care within this large team of mental 
health professionals (e.g., medical family therapists, social workers, psychiatrists, psychologists). They will 
utilize these valuable resources when making referrals for distressed participants in this study. 
There is the possibility of a breach of confidentiality. The consent form will address this possibility. All 
efforts will be made for confidentiality to be maintained by using case numbers to identify participants’ 
research records and by having a limited number of individuals who have access to identifying information. 
Identifying information will be kept separate from research records. All research records will be kept in a 
locked file cabinet and password protected computer files. Only the PI and other trained research staff will 
have access to the research records. The PI has completed Duke University Health System Institutional 
Review Board’s online training course: Protecting Research Subjects, which addresses confidentiality. All
other individuals involved in this study will be required to complete this course and ongoing training.
Privacy, Data Storage & Confidentiality
Complete the Privacy and Confidentiality section of the iRIS submission form.