A Multimedia Self-management Intervention to Prepare Family Caregivers and Patients for Lung Cancer Surgery
Phase: NA
Conditions: Caregiver, Stage I Lung Cancer AJCC v7, Stage IA Lung Cancer AJCC v7, Stage IB Lung Cancer AJCC v7, Stage II Lung Cancer AJCC v7, Stage IIA Lung Cancer AJCC v7, Stage IIB Lung Cancer AJCC v7, Stage III Lung Cancer AJCC v7, Stage IIIA Lung Cancer AJCC v7, Stage IIIB Lung Cancer AJCC v7
Sponsor: City of Hope Medical Center

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 CITY OF HOPE NATIONAL MEDICAL CENTER 
1500 E. DUARTE ROAD 
DUARTE, CA 91010  
 
DEPARTMENT OF Population Sciences, Division of Nursing Research and Education 
 
TITLE:  A Multimedia Self-Management Intervention to Prepare Family Caregivers and 
Patients for Lung Cancer Surgery 
CITY OF HOPE PROTOCOL VERSION: 
IRB # 17238 
Protocol Date: 02/02/2023 
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SPONSOR/IND NUMBER:  R01 CA217841-01A1 
DISEASE SITE: 
Lung 
STAGE (if applicable): 
I-III 
MODALITY: 
Educational/Behavioral 
PHASE/TYPE: 
 
Phase III Interventional 

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PRINCIPAL INVESTIGATOR: 
 
Virginia Sun, PhD, RN 
 
COLLABORATING INVESTIGATOR(S): 
 
Jae Kim, MD  
Dan Raz, MD 
 
 
Loretta Erhunmwunsee, MD
 
 
Betty Ferrell, PhD, FAAN 
J. Mark Erfe 
Maria Pakhdikian, BS, BA, 
MA 
PARTICIPATING CLINICIANS: 
 
Erminia Massarelli, MD, PhD 
Ravi Salgia, MD, PhD 
Jyoti Malhotra, MD 
Ebenezar Daniel, PhD 
 
 
 
STUDY STATISTICIAN: 
 
Oluwatimilehin Timmy 
Okunowo, MPH  
Yi Xiao, MS 
NON- PHYSICIAN CONSENTERS: 
 
Rosemary Prieto, RN, BSN, 
Jacqueline Carranza, BS, 
Elizabeth Bustamante, BA, 
Evelyn Leyva, RN, BSN, 
Fernanda Perez, BS, Randy Lee, 
MHA, Jennifer Tee, RN, BSN, 
Maricela Haj, RN, BSN, Maria 
Pakhdikian, BS, BA, MA 
 

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 CITY OF HOPE NATIONAL MEDICAL CENTER 
1500 E. DUARTE ROAD 
DUARTE, CA 91010  
 
DEPARTMENT OF Population Sciences, Division of Nursing Research and Education 
 
TITLE:  A Multimedia Self-Management Intervention to Prepare Family Caregivers and 
Patients for Lung Cancer Surgery 
CITY OF HOPE PROTOCOL NUMBER: 
17238  
AMENDMENT(S)/REVISION(S):                                                PROTOCOL DATED: 02/02/2023 
Initial Approval 00 
 
Protocol Dated 07/26/17 
 
Version 00 
COH Amendment 01 
 
Title Page Dated 06/15/2018 
 
Version 01 
COH Amendment 02 
 
Title Page Dated 09/28/2018 
 
Version 02 
COH Amendment 03 
             Title Page Dated 10/15/2018 
             Version 03 
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Protocol Dated 10/22/2018 
 
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Protocol Dated 12/03/2018 
 
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SPONSOR/IND NUMBER:  R01 CA217841-01A1 
DISEASE SITE: 
Lung 
STAGE (if applicable): 
I-III 
MODALITY: 
Educational/Behavioral 
PHASE/TYPE: 
 
Phase III Interventional 
 
PRINCIPAL INVESTIGATOR: 
 
Virginia Sun, PhD, RN  

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COLLABORATING INVESTIGATOR(S): 
 
Jae Kim, MD  
Dan Raz, MD  
Loretta Erhunmwunsee, MD 
Betty Ferrell, PhD, FAAN 
 
Dede Teteh, DrPH  
 
 
PARTICIPATING CLINICIANS: 
 
Erminia Massarelli, MD, PhD 
Ravi Salgia, MD, PhD 
Jyoti Malhotra, MD 
 
 
STUDY STATISTICIAN: 
 
Oluwatimilehin Timmy Okunowo, MPH  
Yi Xiao, MS 
NON- PHYSICIAN CONSENTERS: 
 
Rosemary Prieto, RN, BSN, Jacqueline Carranza, 
BS, Elizabeth Bustamante, BA, Evelyn Leyva, RN, 
BSN, Fernanda Perez, BS, Randy Lee, MHA, 
Jennifer Tee, RN, BSN, Maricela Haj, RN, BSN 
 

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Experimental Design Schema 
 
• View American Cancer 
Society (ACS) Video - 
Clinical Trials 
• Review ACS Materials on 
Clinical Trials 
 
Family Caregivers and Patients Scheduled to Undergo Lung Cancer Surgery 
Informed Consent 
Baseline Assessment 
Randomization 
MSM INTERVENTION 
(RN)
ATTENTION CONTROL 
(CRA) 
• View ACS Video – Clinical 
Trials 
• Review ACS Materials on 
Clinical Trials 
 
• View Session 2 Video (What 
To Expect After Discharge) 
• Review of Handbook  
• Daily Self-Monitoring 
• Self-Management Coaching 
SURGERY 
SURGERY 
Study Schema 
• View Session 1 Video (What 
to Expect Before and After 
Surgery) 
• Review of Handbook 
• Self-Management Coaching 
3 Months Post-Discharge 
Assessment 
Discharge Assessment 
Discharge Assessment 
1 Month Post-Discharge 
Assessment 
CRA Telephone Support 
(Sessions 3 & 4) 
• Day 2 Post-Discharge 
• Day 7 Post-Discharge 
RN Telephone Support 
(Sessions 3 & 4) 
• Day 2 Post-Discharge 
• Day 7 Post-Discharge 
1 Month Post-Discharge 
Assessment 
3 Months Post-Discharge 
Assessment 
RN Telephone Support 
(Session 5) 
• 2 months Post-Discharge 
CRA Telephone Support 
(Session 5) 
• 2 months Post-Discharge 

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Protocol Synopsis 
Protocol Title: 
A Multimedia Self-Management Intervention to Prepare Family Caregivers and Patients for Lung 
Cancer Surgery 
Brief Protocol Title for the Lay Public (if applicable): 
Preparing Family Caregivers and Patients for Lung Cancer Surgery using a Multimedia 
Intervention 
Study Phase: 
Phase III Interventional 
Participating Sites: 
None 
Rationale for this Study: 
Lung cancer surgery patients are a unique population with significant acute and chronic 
caregiving needs. Patients are older, have greater co-morbidities (pulmonary, cardiovascular), 
higher psychological distress, and decreased physical functioning. Caregiving demands are high 
due to acute effects (pain, fatigue) and chronic pulmonary function deficits. As cancer care 
continues to move further into the home setting, family caregivers (FCGs) and patients may be 
ill-prepared for recovery at home. This can potentially result in significant morbidity, undesirable 
healthcare resource use, and immense social and economic costs for both FCGs and patients. 
Despite the tremendous caregiving burden, family caregiver interventions have been understudied 
in cancer surgery, and there is a significant, unmet need for family-centered models of care in this 
area. 
Objectives: 
The primary purpose of this trial is to test the efficacy of a Multimedia Self-Management (MSM) 
Intervention in 200 lung cancer surgery caregiver-patient dyads, comparing intervention and 
attention control groups.     
Study Design: 
This is a Phase III, prospective, longitudinal, mixed-methods RCT designed to test the efficacy of 
the MSM Intervention in lung cancer surgery. The use of an attention control condition as the 
comparison group will minimize the potential for Hawthorne’s effect. Building from our previous 
work and based on the Chronic Care Self-Management Model (CCM), the MSM Intervention is a 
nurse-led, caregiver-based, telehealth, multimedia care model for lung cancer surgery. Its primary 
focus is to provide support for FCGs on their post-operative caregiving role and managing their 
QOL needs through goal setting, proactive planning, and building self-management and problem-
solving skills. The MSM Intervention also supports caregiver-patient dyads in preparing for 
surgery and self-management during post-operative recovery at home. The MSM Intervention 
includes video, handbook, and post-discharge telephone support.  It is administered at five time 
points: before surgery, during hospitalization, and at Day 2, Day 7, and 2 months post-discharge. 
It utilizes both in-person encounters as well as telephone for intervention administration. 
Endpoints: 
Primary: 
Family Caregivers: Burden, Caregiving Preparedness, Psychological Distress, QOL, Cancer 
support services use 

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Patients: Psychological distress, QOL, Healthcare Resource Use (home health nursing care, 
urgent care/ER visits, readmissions) 
Outcome Mediators: Activation, Self-Efficacy, Surgery-Related Knowledge 
Secondary: 
Moderators of FCG/patient outcomes and reciprocal relationships 
Additional Studies: 
Geriatric Assessment for FCGs and patients 
Social determinants of health 
Spiritual Well-Being 
Sample Size: 
200 family caregiver-patient dyads (400 participants total) 
Estimated Duration of the Study 
60 months 
Summary of Subject Eligibility Criteria: 
Inclusion Criteria: 
Family caregiver: 1) A family member or friend identified by the patient as being the primary 
care provider before and after surgery; 2) A patient/care recipient enrolled in the study; 3) Age 21 
years or older; 4) Able to read or understand English or Chinese. 
Patient: 1) Diagnosis of lung cancer or presumed lung cancer (as determined by surgeons); 2) 
Scheduled to undergo surgery for treatment; 3) A family caregiver enrolled in the study; 4) Age 
21 years or older; and 5) Able to read or understand English or Chinese. 
Investigational Product Dosage and Administration: 
Not Applicable 
Clinical Observations and Tests to be Performed: 
Disease and surgical characteristics: date of diagnosis, pre-operative risk factors, pre-operative 
treatments, pre-operative pulmonary function tests, date of surgery, type of surgical procedures, 
admission date and status, clinical staging, postoperative events/complications, discharge date 
and status, discharge disposition, pathological staging, and smoking cessation plans, 
postoperative urgent care/ER visits, and 30 and 90-day hospital readmissions. Geriatric 
assessment for FCGs (baseline, 3 months) and patients (baseline, first postoperative clinic visit, 
and 3 months). 
Statistical Considerations: 
In Aims 1, 2, and 3, outcomes and mediators will be examined across 3 time points (discharge, 1 
and 3 months post-discharge) by treatment group using baseline as covariates. We will also test 
intervention effects on FCG cancer support services use and patient healthcare resource use. The 
primary outcome is the change in scores from baseline to discharge (immediate effect) and 3 
months post-discharge (sustained effect). In EA 1, we will explore moderators and reciprocal 
relationships. In EA 2, we will qualitatively explore participants’ experience with the MSM 
Intervention.    
Sponsor/Licensee: 
National Cancer Institute 
Case Report Forms 
Not Applicable 

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Table of Contents 
SECTION.................................................................................................................. PAGE 
Experimental Design Schema .......................................................................................................... 2 
Protocol Synopsis ............................................................................................................................. 3 
Table of Contents ............................................................................................................................. 5 
Abbreiviations .................................................................................................................................. 8 
1.0 
Goals and Objectives (Scientific Aims) ............................................................................ 10 
2.0 
Background ....................................................................................................................... 11 
2.1 
Introduction/Rationale for Development ............................................................. 11 
2.2 
Overview of Proposed Study ............................................................................... 14 
2.3 
Preclinical Studies ................................................................................................ 14 
2.4 
Human Studies ..................................................................................................... 14 
3.0 
Patient Eligibility .............................................................................................................. 15 
3.1 
Inclusion Criteria ................................................................................................. 15 
3.1.1 
Disease Status ......................................................................................... 16 
3.1.2 
Age Criteria, Performance Status and Life Expectancy ......................... 16 
3.1.3 
Child Bearing Potential ........................................................................... 16 
3.1.4 
Protocol-Specific Criteria ....................................................................... 16 
3.1.5 
Informed Consent/Assent ....................................................................... 16 
3.1.6 
Prior Therapy .......................................................................................... 16 
3.2 
Exclusion Criteria ................................................................................................ 16 
3.2.1 
Study-Specific Exclusions ...................................................................... 16 
3.2.2 
Non-Compliance ..................................................................................... 17 
3.3 
Inclusion of Women and Minorities .................................................................... 17 
4.0 
Screening and Registration Procedures............................................................................. 17 
4.1 
Screening Procedures ........................................................................................... 17 
4.2 
Informed Consent ................................................................................................ 17 
4.3 
Registration Requirements/Process ..................................................................... 17 
4.4 
Randomization and/or Dose Level Assignment................................................... 18 
5.0 
Treatment Program ........................................................................................................... 18 
5.1 
Intervention Overview ......................................................................................... 18 
5.2 
Planned Duration of Therapy ............................................................................... 22 

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5.3 
Criteria for Removal from Treatment .................................................................. 22 
5.4 
Subject Follow-Up ............................................................................................... 23 
5.5 
Supportive Care, Other Concomitant Therapy, Prohibited Medications ............. 23 
5.6 
AdditionalStudies ................................................................................................. 23 
5.6.1 
Laboratory Studies .................................................................................. 27 
5.7 
Definition of Dose-Limiting Toxicity (DLT) ...................................................... 27 
6.0 
Dose Delays/Modifications for Adverse Events ............................................................... 27 
7.0 
Data and Safety Monitoring, Unanticipated Problems and Adverse Event Reporting ..... 27 
7.1 
Definition of Risk Level ...................................................................................... 27 
7.2 
Monitoring and Personnel Responsible for Monitoring ...................................... 22 
7.3 
Unanticipated Problems (UP)  Involving Risks to Subjects or Others Error! 
Bookmark not defined. 
7.4 
Deviations ............................................................................................................ 23 
8.0 
Agent Information and Risks ............................................................................................ 28 
9.0 
Correlative/Special Studies ............................................................................................... 28 
10.0 
Study Calendar .................................................................................................................. 29 
11.0 
Endpoint Evaluation Criteria/Measurement of Effect ...................................................... 31 
11.1 
Response Criteria ................................................................................................. 31 
12.0 
Data Reporting/Protocol Deviations ................................................................................. 31 
12.1 
Data Reporting ..................................................................................................... 31 
12.1.1 Confidentiality and Storage of Records .................................................. 31 
12.1.2 Subject Consent Form ............................................................................. 31 
12.1.3 Data Collection Formsand Submission Schedule ................................... 31 
12.2 
Protocol Deviations .............................................................................................. 35 
12.2.1 Deviation Policy ..................................................................................... 35 
12.2.2 Reporting of Deviations .......................................................................... 35 
12.2.3 Resolving Disputes ................................................................................. 35 
13.0 
Statistical Considerations .................................................................................................. 36 
13.1 
Study Design ........................................................................................................ 36 
14.0 
Human Subject Issues ....................................................................................................... 42 
14.1 
Institutional Review Board .................................................................................. 42 
14.2 
Recruitment of Subjects ....................................................................................... 42 
14.3 
Advertisements .................................................................................................... 42 
14.4 
Study location and Performance Sites ................................................................. 42 
14.5 
Confidentiality ..................................................................................................... 42 
14.6 
Financial Obligations and Compensation ............................................................ 42 

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14.7 
Informed Consent Processes ................................................................................ 43 
15.0 
References ......................................................................................................................... 43 
 

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Abbreviations 
Abbreviation 
Meaning 
ACoS 
American College of Surgeons 
COH 
City of Hope 
CRA 
Clinical Research Associate 
DSMC 
Data Safety Monitoring Committee 
FCG 
Family Caregiver 
NSCLC 
NCI 
Non-Small Cell Lung Cancer 
National Cancer Institute 
PI 
Principal Investigator 
PMT 
PRO 
Protocol Monitoring Team 
Patient-Reported Outcomes 
QOL 
RCT 
Quality of Life 
Randomized Control Trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 
Goals and Objectives (Scientific Aims) 
 
More than 520,000 Americans, most over age 65, carry a diagnosis of lung cancer.1 The 
number of individuals diagnosed with early stage lung cancer is projected to increase due to 
advances in screening and early detection.2 Surgery is the primary treatment for early stage lung 
cancer.1 Due to changes in the healthcare environment as well as advances in surgical care, lung 
cancer patients are discharged from the hospital earlier after surgery. As such, a greater 
proportion of the caregiving burden has fallen on family caregivers (FCGs).3   
Our previous research suggests that lung cancer FCGs experience significant 
psychological distress and decreased quality of life (QOL) related to their caregiving role.4-6 
Lung cancer surgery patients are a unique population with significant acute and chronic 
caregiving needs. Patients are older, have greater co-morbidities (pulmonary, cardiovascular), 
higher psychological distress, and decreased physical functioning. Caregiving demands are high 
due to acute effects (pain, fatigue) and chronic pulmonary function deficits. As cancer care 
continues to move further into the home setting, FCGs and patients may be ill-prepared for 
recovery at home. This can potentially result in significant morbidity, undesirable healthcare 
resource use, and immense social and economic costs for both FCGs and patients. Despite the 
tremendous caregiving burden, FCG interventions have been understudied in cancer surgery, and 
there is a significant, unmet need for family-centered models of care in this area. The primary 
purpose of this trial is to test the efficacy of a Multimedia Self-Management (MSM) 
Intervention in 200 lung cancer surgery caregiver-patient dyads.    
Building from our previous work and based on the Chronic Care Self-Management 
Model (CCM), the MSM Intervention is a nurse-led, caregiver-based, telehealth, multimedia care 
model for lung cancer surgery. Its primary focus is to provide support for FCGs on their post-
operative caregiving role and managing their QOL needs through goal setting, proactive 
planning, and building self-management and problem-solving skills. The MSM Intervention also 
supports caregiver-patient dyads in preparing for surgery and self-management during post-
operative recovery at home. The MSM Intervention includes video, handbook, and post-
discharge videoconference support.  It is administered at five time points: before surgery, during 
hospitalization, and at Day 2, Day 7, and 2 months post-discharge. It utilizes both in-person 
encounters as well as videoconferencing for intervention administration. We have preliminary 
data (N=60) that the MSM Intervention is feasible and acceptable. Our central hypothesis is that 
the MSM Intervention will improve dyadic outcomes and healthcare resource/cancer support 
services use by enhancing activation, self-efficacy, and knowledge as compared to an attention 
control group. Accordingly, we propose the following specific aims: 
Specific Aim 1: Test the effects of the MSM Intervention on FCG outcomes and cancer support 
services use at discharge and 3-months post-discharge, comparing intervention and attention 
control groups. 
Hypothesis 1.1: The intervention group will experience lower psychological distress and 
caregiver burden. 
Hypothesis 1.2: The intervention group will experience higher caregiving preparedness and 
QOL. 
Hypothesis 1.3: The intervention group will have lower social work referrals and higher family 
resource center use.  
Specific Aim 2: Test the effects of the MSM Intervention on patient outcomes and healthcare 
resource use at discharge and 3-months post-discharge, comparing intervention and attention 
control groups. 

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Hypothesis 2.1: The intervention group will experience lower psychological distress and higher 
QOL. 
Hypothesis 2.2: The intervention group will have lower in-home nursing care, lower urgent 
care/ER visits, and lower hospital readmissions. 
Specific Aim 3: Test the effects of the MSM Intervention on outcome mediators at discharge 
and 3-months post-discharge, comparing intervention and attention control groups. 
Hypothesis 3.1: FCGs and patients in the intervention group will experience higher activation, 
self-efficacy, and knowledge. 
Exploratory Aims:   
EA 1: Explore moderators (age, sex, marital status, caregiver relationship to patient, caregiver 
employment status, co-morbidities) of FCG and patient outcomes and reciprocal relationships.  
EA 2: Determine, through exit interviews, participant’s experience with the MSM 
intervention. 
This application addresses key research priorities specified in NCI PAR-16-317, 
“Intervening with Cancer Caregivers to Improve Patient Health Outcomes and Optimize Health 
Care Utilization.”7 It addresses two key priorities of the American College of Surgeons (ACoS): 
1) the critical role of patients and families as integral members of the surgical team, and 2) that 
the active involvement of patients and families as partners in surgical care can decrease 
complications through timely identification of risks.8 With regards to impact, this trial seeks to 
fill critical knowledge gaps in cancer surgical care where FCG needs are not addressed. Our 
long-term goal is to prove that the CCM can be applied to patients with lung cancer and their 
FCGs to better prepare them for surgery, improve postoperative outcomes, and optimize 
healthcare resource/cancer support services use. 
2.0 
 Background 
2.1 
Introduction/Rationale for Development 
 
Lung cancer is one of the most common cancers and the leading cause of cancer death for 
both men and women in the United States.1 Lung cancer patients report higher levels of distress, 
anxiety, fatigue, and dyspnea than other cancer patients at baseline.9, 10 The majority of lung 
cancer patients are older; median age at diagnosis is 70.11 Tobacco-related comorbid conditions, 
such as chronic obstructive pulmonary disease (COPD) and cardiovascular diseases, are 
common.12 Lung cancer treatments often exacerbate these problems. Surgery is a key component 
in the treatment for most patients with non-metastatic lung cancer, but by its very nature, lung 
resection can significantly worsen QOL.13 Patients experience pain, fatigue, loss of respiratory 
capacity, and decreased physical function after lung cancer surgery.14  The most common 
resection performed for lung cancer is a lobectomy, which typically removes about 20-25% of a 
patient’s lung.  After lobectomy, pulmonary function declines to less than half of baseline in the 
immediate post-operative period.15  More extensive resections result in even greater decline in 
lung function.  Some aspects of QOL remain compromised long-term, for 6 months or longer 
after lung cancer surgery.16   
 
Due to the impact of lung cancer surgery on patients who have existing severe co-
morbidities, this population has an ongoing need for care and major resource use after discharge 
from the hospital. Whereas only 6% of patients die during the initial hospitalization after lung 
cancer surgery, twice that number will die in the six months after discharge.14  Almost a third of 
patients are discharged with some type of formal, paid home health care, 9% of patients are 

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transferred to another facility, and 20% of patients are readmitted within 90 days.17  This is 
occurring while patients are being discharged earlier after surgery, ultimately resulting in FCGs 
taking on greater responsibility for recovery at home. 
Post-operative caregiving is an intense experience for lung cancer FCGs. During care 
transitions such as hospital discharge, only 54% of FCGs report having ever been asked about 
their caregiving needs.18 Alarmingly, only 29% of cancer caregivers report addressing their own 
self-management needs.19 The caregiving role is a major source of stress and burden for FCGs of 
lung cancer patients and has a negative impact on their QOL.4, 5, 20 FCGs report significant 
negative physical health and emotional effects of caregiving.21, 22 Common adverse economic 
and social effects of lung cancer caregiving include less engagement with social activities and 
reduced work hours.23, 24 Key caregiving challenges for lung cancer FCGs include a profound 
sense of uncertainty in the patient’s potential for functional decline, distress related to managing 
the patient’s emotional reactions to lung cancer, and managing the practical challenges of 
caregiving.25 Despite the significant QOL issues, few FCGs report using mental health and 
support services.26 Beyond utilizing existing mental health and support services, lung cancer 
FCGs also desire skills for self-management of QOL concerns.27 
FCGs and patients often experience heightened feelings of powerlessness before and after 
lung cancer surgery.28, 29 The transition from postsurgical hospitalization to self-management 
post-discharge is frequently threatened by unmet discharge needs30, decreased patient functional 
health status, and increased caregiving burden.31, 32 In this setting, FCGs and patients are often 
expected to take responsibility for self-managing recovery at home while still experiencing the 
physical and psychological effects of surgery.33, 34 Being adequately prepared for surgery and 
self-management has the potential to empower patients and families, lower distress, and improve 
QOL.35 This model of care enables and empowers FCGs and patients to achieve their own goals 
of care.34, 36 The IOM defines self-management support as the “systematic provision of 
interventions to increase skills and self-efficacy in managing health problems, including regular 
assessment of problems, goal setting and problem-solving support.”37  
 
Previous research indicates the need for interventions that jointly examine dyadic 
outcomes. In general, significant effects were observed for emotional distress38, improvements in 
problem-solving ability39, decreased negative appraisal of caregiving40, and psychosocial well-
being.41 Despite the tremendous caregiving burden associated with cancer surgery, there is an 
unmet need for evidence-based interventions for FCGs in this population.  Caregiving for cancer 
surgery patients is fundamentally different than the non-surgical population, characterized by 
multiple transitions in caregiving burden, but FCG interventions in lung cancer have focused 
primarily on advanced/metastatic stage populations. Out of 27 published RCTs of FCG 
interventions in adults with cancer, none were specific to surgical populations.42  A recent 
systematic review of preparatory interventions for cancer patients undergoing surgery found 
there were no trials involving FCGs and concluded that “further work should be directed at 
multi-modal interventions, and those that include FCGs, given their role in assisting patients to 
prepare and recover from surgery.”43 There is an even greater need for interventions specific for 
lung cancer surgery given the high level of caregiving demands in this population.  
Our scientific premise is based on three key areas. First, there is high quality evidence to 
support the use of the CCM in the cancer population. Multiple RCTs have demonstrated the 
efficacy of self-management approaches in the setting of chronic illness.44  The positive benefits 
of the CCM are found in COPD45, diabetes46, and cancer survivorship.47 They suggest that self-
management coaching-based interventions are effective in improving physical and psychosocial 
health status, health behaviors, and healthcare resource use (ER visits, at home nursing care, 

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readmissions).45-49 Over 40 RCTs have examined self-management interventions for cancer 
patients, with many demonstrating improved QOL.50  A significant weakness of the evidence is 
the heterogeneity of interventions and a relative lack of mechanistic data to clearly indicate 
which core elements are most essential.  Observational evidence in lung cancer suggest that 1) 
patients with low self-efficacy who also had an FCG with low self-efficacy reported worse 
physical and psychological well-being; 2) dyads with high self-efficacy reported better QOL; and 
3) low FCG self-efficacy is associated with higher FCG distress and caregiver burden.51 This 
suggests that interventions targeted at increasing self-efficacy and self-management may be 
beneficial for this population. There is much more limited data for the use of self-management 
strategies specific to cancer surgery.52, 53  Second, multiple studies have demonstrated that in a 
variety of settings, multimedia approaches to intervention delivery are superior in knowledge-
transfer and skills building compared to print materials only. Recent meta-analyses found that 
video interventions in cancer were as effective, and in some RCTs, superior in knowledge 
transfer to print materials alone.54 Videos may be especially suitable for participants with low 
health literacy, and are more scalable for future dissemination purposes.54 A weakness in the 
evidence is the lack of studies demonstrating the effectiveness of multimedia interventions for 
self-management in FCGs of surgical patients. Third, our previous work with a nurse-led 
palliative care intervention found that dyadic interventions for symptom management can 
improve QOL outcomes in lung cancer surgery. However, the intervention was a) not 
conceptually-based, b) not scalable, and c) focused on traditional educational approaches rather 
than self-management skills-building.  
This randomized trial is innovative in several aspects. 1) The timing of the intervention is 
novel, with delivery beginning in the preoperative setting.  Very few FCG interventions have 
been examined in cancer surgery and there are virtually no FCG interventions that begin prior to 
surgery.  Beginning the intervention before surgery offers potential advantages to FCGs and 
patients.  Early patient discharge has meant less time to intervene with FCGs after surgery before 
caregiving begins at home.  Beginning support in the lead up to surgery allows dyads to become 
familiar with elements of the intervention before they undergo the physical and psychological 
stress of surgery.  Data from pulmonary rehabilitation studies indicate that the addition of 
preoperative education may be more effective than post-operative teaching intervention alone.55 
We have found that the preoperative period is a time of great psychological distress for both 
FCGs and patients, and is an area of significant unmet need.56  2) The application of the self-
management (CCM) model to the surgical setting is novel.  Previous CCM interventions for 
FCGs have focused on chronic illnesses.  Application of the CCM to cancer surgery represents 
an important step in the use of self-management for FCG well-being and a significant change in 
surgical practice paradigm.  Previous CCM-based content do not address caregiving needs after 
cancer surgery. The caregiving experience after lung cancer surgery is characterized by an acute 
increase in caregiving burden followed by a gradual decrease and a more chronic phase.56 Our 
study uniquely allows us to assess the efficacy of self-management through these transitions in 
peri-operative caregiving.  In contrast with most chronic illnesses, the surgical setting also allows 
for the self-management intervention to be delivered in a more anticipatory fashion. 3) 
Scalability of the intervention. Our trial builds on our previous work with a palliative care 
intervention for lung cancer dyads of all stages.  The intervention was relatively resource 
intensive, requiring multiple hour-long, face-to-face education sessions with an advanced 
practice nurse.  It also required weekly, face-to-face interdisciplinary care meetings, which was 
challenging to implement given clinicians’ busy schedules.  The intervention also resulted in less 
QOL benefits for FCGs of surgical patients compared to advanced stage patients.  Guided by this 

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previous experience, we developed the proposed intervention with multimedia resources that 
specifically addresses the post-operative recovery needs of FCGs and patients.  The multimedia 
resources are readily adaptable for any hospital that performs lung cancer surgery and can easily 
be accessed over the internet, making the intervention easily scalable.  In addition, successful 
application of the CCM to this cancer population could lead to similar interventions for other 
surgical patients and their FCGs. There is data that self-management interventions may be 
particularly useful in resource poor populations.57  
In summary, overwhelming evidence illustrates: 1) Significant QOL issues and 
healthcare resource utilization for lung cancer patients after surgery; 2) Significant QOL issues 
and caregiving burden for FCGs after cancer surgery; and 3) Large unmet need for evidence-
based FCG interventions in cancer surgery. Our trial has great potential for success based on the 
evidence supporting our scientific premise. 
 
2.2 
Overview of Proposed Study 
This prospective, longitudinal, mixed-methods RCT is designed to test the efficacy of the 
MSM Intervention in lung cancer surgery. In Aims 1, 2, and 3, outcomes and mediators will be 
examined across 3 time points (discharge, 1 and 3 months post-discharge) by treatment group 
using baseline as covariates We will also test intervention effects on FCG cancer support 
services use and patient healthcare resource use. The primary outcome is the change in scores 
from baseline to discharge (immediate effect) and 3 months post-discharge (sustained effect). In 
EA 1, we will explore moderators and reciprocal relationships. In EA 2, we will qualitatively 
explore participants’ experience with the MSM Intervention.    
This study will be conducted in compliance with the protocol, Good Clinical Practice 
(GCP) and the applicable regulatory requirements. 
 
2.3 
Preclinical Studies 
Not Applicable 
 
2.4 
Human Studies 
This trial builds directly from an NCI-funded Program Project (P01CA136396, 2009-
2014 - PI: Ferrell) that tested a palliative care intervention in lung cancer.58, 59 We conducted 
several subset analyses using data from the Program Project that informed this trial: 
FCG’s Distress Levels, QOL, Burden, and Preparedness – Using usual care group data of 
163 FCGs, we found that high caregiver burden and low QOL were common. Subjective stress 
(emotional impact of caregiving) was high. Caregiving demands increased progressively through 
including surgery and as the patient’s conditions worsened.5 FCG psychological distress was 
correlated with QOL, subjective stress burden, and perceived preparedness for caregiving. We 
identified 3 constructs were that were associated with FCG well-being: 1) ability to manage their 
own healthcare and QOL needs; 2) perceived preparedness for caregiving and its impact on 
burden; and 3) perceived emotional distress caused by the caregiving role.4 
QOL and Psychological Distress Trajectories in Lung Cancer Patients and FCGs After 
Surgery –  To further investigate the effects of lung cancer surgery on QOL, we performed a 
subset analysis of 41 dyads of lung cancer patients and FCGs (N=82). We observed significant 
incongruence between patient and FCG outcomes. Psychological distress levels were high for 

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both patients and FCGs before surgery (3.8/10 patients, 5.1/10 caregivers). Distress levels in 
patients significantly decreased at 6 and 12 weeks after surgery (2.9/10 and 2.2/10, p=.001). 
However, distress levels did not improve for FCGs from 6 to 12 weeks (4.2/10 and 4.4/10, 
p=.157). FCGs did not experience significant improvements in emotional QOL.6  
FCG and Patient Informational Needs in Lung Cancer Surgery - Using implementation 
process data, we described the most important QOL topics for early stage lung cancer FCGs and 
patients. For FCGs (N=65), fatigue, pain, breathing problems/cough, and sleep problems were 
the most frequently selected physical well-being topics. For psychological well-being, worry/fear 
and depression were most common. For social well-being, changes in relationships and social 
support were the most frequently selected topics.60 Patient’s preference for educational topics 
(N=123) was similar compared to FCGs. Based on these findings, we developed a preliminary 
version of the MSM Intervention. This version was presented to seven FCGs and patients for 
review. They confirmed the importance of including community resources, practical caregiving 
tips, and addressing anxiety. Areas for improvements included emphasizing breathing exercises 
and minimizing sleep disturbance, and cough.61 
Pilot Study of the MSM Intervention - A quasi-experimental pilot study was conducted to 
evaluate the feasibility and acceptability of the MSM Intervention (published in Clinical Lung 
Cancer).62 The study enrolled FCGs and patients with cancer who were treated with lung 
resection. Participants were enrolled before surgery (baseline) and followed for 2-4 weeks after 
discharge. The first 20 dyads received usual care, and the second group of 20 received the MSM 
Intervention. The MSM Intervention was delivered at 4 time points: 1) before surgery, 2) before 
discharge, and 3) twice after discharge via telephone calls.  A total of 60 participants (22 FCGs, 
38 patients) completed the pilot study. Enrollment rate over 12 months was 70% for all eligible 
participants. A total of 13 participants (6 patients, 7 FCGs) dropped out of the study (17.8% 
attrition). Thirty-eight percent of participants were ethnic minorities. Mean age for FCGs was 
61.6, and 70.2 for patients. FCGs assigned to the MSM Intervention (N=11) were highly 
satisfied with the overall intervention (3.6/4.0), the amount of information provided (70% “just 
right”), and the intervention timing (100% “just right”). FCG surgery-related knowledge scores 
were significantly improved post-intervention (8.1 to 9.6, 1.5 point difference, p=0.02). A trend 
for improvement was observed for the subjective demand subscale (p=0.09) for caregiver burden 
(defined as the extent to which FCGs feel care responsibilities are overly demanding). Emotional 
QOL was significantly improved post-intervention for MSM Intervention group patients (15.8 to 
19.8, p=0.001). Trends for significant improvements in self-efficacy (p=0.09) and patient 
surgery-related knowledge (p=0.06) were seen. Activation scores improved an average of 4.6 
points post-intervention; this difference is clinically meaningful.63 Unscheduled visits were 
similar (8 patients for intervention group versus 7 in usual care). 
 
3.0 
Patient Eligibility 
3.1 
Inclusion Criteria 
 
The study sample will consist of 200 caregiver-patient dyads (100 per randomization 
group) who are scheduled to undergo lung cancer surgery. Participants will be enrolled as dyads 
only. FCG eligibility criteria include: 1) A family member or friend identified by the patient as 
being the primary care provider before and after surgery; 2) A patient/care recipient enrolled in 
the study; 3) Age 21 years or older; and 4) Able to read or understand English or Chinese - the 
intervention and outcome measures are not validated in other languages. Our intent is to adapt 

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and test the intervention in a future study with linguistically and culturally diverse populations. 
Patient eligibility criteria include: 1) Diagnosis of lung cancer or presumed lung cancer (as 
determined by surgeons); 2) Scheduled to undergo surgery for treatment; 3) A FCG enrolled in 
the study; 4) Age 21 years or older; and 5) Able to read or understand English or Chinese.  
 
3.1.1 Disease Status 
This trial will be conducted in FCGs and patients who are scheduled to undergo lung 
cancer surgery for treatment. We are targeting patients with stage I-III disease with resectable 
disease only.  
 
3.1.2 Age Criteria, Performance Status and Life Expectancy 
Age criterion for this trial is based on the NIH’s age criteria, which defines an adult as 
individuals aged 21 years and over. There are no restrictions related to performance status or life 
expectancy.  
 
3.1.3 Child Bearing Potential 
Not Applicable 
 
3.1.4 Protocol-Specific Criteria 
Not Applicable 
 
3.1.5 Informed Consent/Assent 
This protocol is eligible for waiver of informed consent documentation because the risk 
level is low. All subjects must have the ability to understand and the willingness to provide 
verbal informed consent.  
 
3.1.6 Prior Therapy 
Not Applicable 
 
3.2 
Exclusion Criteria 
 
Not Applicable 
 
3.2.1 Study-Specific Exclusions 
Not Applicable 
 

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3.2.2 Non-Compliance 
Subjects, who in the opinion of the investigator, may not be able to comply with the 
safety monitoring requirements of the study. 
3.3 
Inclusion of Women and Minorities 
The study is open to anyone regardless of gender or ethnicity. Efforts will be made to 
extend the accrual to a representative population. 
 
4.0 
 Screening and Registration Procedures 
4.1 
Screening Procedures 
All eligible FCGs and patients who meet study inclusion criteria will be identified 
through the Division of Thoracic Surgery (Dr. Kim, Dr. Raz, and Dr. Erhunmwunsee). This trial 
will employ 1 Research Nurse and 2 CRAs to implement the study. The Research Nurse and 
CRAs, working closely with the Division of Thoracic Surgery, will attend key clinics and 
meetings (ambulatory clinics, tumor boards) on a weekly basis to identify eligible participants. 
They will contact eligible participants and explain the study purpose, answer questions, and 
ascertain interest in participation. If the participant agrees to enroll, informed consent will be 
obtained. The Research Nurse and one CRA will be responsible for obtaining informed consent, 
intervention implementation, and data collection. Chinese-speaking participants will be 
consented using IRB translated and approved Chinese version of the forms. The study employs 
bilingual research staff that will complete informed consent and all study activities in the 
appropriate language; no translators will be used.  
 
4.2 
Informed Consent 
Study objectives and procedures, and their attendant risks and discomforts, will be 
carefully explained to the potential participants. Informed consents will be obtained in person or 
via mail, electronic mail, or other electronic applications (i.e. DocuSignTM) to obtain electronic 
signatures from each patient per standard practice. If necessary (i.e. if potentials have left the 
clinic), a telephone/verbal informed consent will be obtained first in order to begin study in a 
timely manner. Signed informed consent will then be obtained for this study either in person 
when participants are at COH or via mail, electronic mail, or other electronic applications (i.e. 
DocuSignTM). For FCGs who may not accompany participants to clinic visits, the consent for 
signature will be emailed or mailed to them and returned to COH when signed, or completed by 
other electronic application (i.e. DocuSignTM) to obtain electronic signature per standard 
practice. 
 
4.3 
Registration Requirements/Process 
The Research Nurse and CRA will establish eligibility and consent before contacting the 
registrar at the time of enrollment. The registrar will enter the patient on a pre-established 
randomization log, and report the assignment to the Research Nurse and CRA, who will then 
communicate the assignments to the participants in both study arms. Participants will complete 
baseline assessment following informed consent.  

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4.4 
Randomization and/or Dose Level Assignment 
Each FCG-patient dyad will be randomly assigned to either the MSM Intervention or 
attention control group, using a stratified and blocked randomization. Strata are defined by 
surgical approach (open or minimally-invasive).  Variable block sizes will be used to maintain 
approximate balance and pre-assignment masking. 
 
5.0 
 Treatment Program 
5.1 
Intervention Overview – Conceptual Framework 
 
The MSM Intervention is based on the Chronic Care Self-Management Model (CCM).64-
66 The CCM transforms a reactive health system into one that improves FCG and patient 
outcomes through proactive planning and self-management skills building.67 The CCM is based 
on social cognitive theory and focuses on skills building to empower and engage individuals in 
their own care. Self-management includes goal setting, problem solving, and post-operative 
recovery/caregiving skills building. Self-management coaching complements traditional 
education in supporting patients and FCGs to live the best possible QOL before and after 
surgery. The MSM Intervention combines both traditional (information and technical skills) and 
self-management education (enhance activation, self-efficacy, and confidence in using the 
information and technical skills).  
 
As depicted in Figure 1, FCGs and patients bring personal and health status factors that 
will influence their capacity to integrate self-management strategies into their daily activities.  
These factors (e.g. age, sex, marital status, FCG relationship to patient, FCG employment status, 
co-morbidities) are potential moderators based on the current literature that influence 
intervention uptake.20, 68-71 We hypothesize that the MSM Intervention, as guided by the Chronic 
Care Self-Management Model, will enhance outcome mediators, such as activation (confidence 
in their ability to manage their health) and self-efficacy (confidence to carry out behaviors 
necessary to achieve a desired goal), and knowledge.34, 72 The mediator effects, based on CCM 
evidence72, are hypothesized to serve as the mechanisms whereby the MSM Intervention 
improves FCG and patient outcomes (psychological distress, caregiver burden, preparedness for 
 
 
 
 
 
 
 
  
 
 
 
 • Age 
 • Sex 
 • Marital status 
 • FCG relationship 
to patient  
 • FCG employment 
status 
 • Co-morbidities 
Moderators 
Chronic Care Self-
Management 
• Goal setting 
• Proactive planning 
• Problem-solving 
• Self-management 
skills for post-op 
recovery and 
caregiving 
Figure 1. Conceptual Framework 
 
•    Activation 
•    Self-Efficacy 
•    Knowledge 
Outcome Mediators 
•    Psychological    
Distress 
•    Quality of Life 
•    Urgent care/ER visits 
•    In-home nursing care 
•    Patient readmissions 
•     Psychological Distress 
•     Caregiver Burden 
•     Preparedness for   
Caregiving 
•     Quality of Life   
•     Social work resources 
•     Resource center use 
Patient Outcomes 
FCG Outcomes 
Exploratory Aims:   
EA 1: Explore moderators of 
FCG and patient outcomes.  
EA 2: Determine, through exit 
interviews, components 
participant’s experience with 
the MSM Intervention. 
Specific Aim 1: Test the 
effects of the MSM 
Intervention on FCG 
outcomes and cancer 
support services use at 
discharge and 3-months 
post-discharge. 
Specific Aim 2: Test 
the effects of the MSM 
Intervention on patient 
outcomes and 
healthcare resource use 
at discharge and 3-
months post discharge. 
 
Specific Aim 3: Test 
the effects of the 
MSM Intervention on 
outcome mediators 
at discharge and 3-
months post 
discharge. 
EA 1: Explore 
reciprocal 
relationships of 
FCG and 
patient 
outcomes. 

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caregiving, QOL, healthcare resource/cancer support services use). Reciprocal interactions (EA 
1) between FCG and patient outcomes are hypothesized to be interrelated.4-6  Evidence from our 
work suggest that lung cancer FCGs’ and patients’ psychological distress are correlated; FCG 
distress is associated with perceived burden, caregiving preparedness, as well as patient physical 
and psychological well-being.4, 5, 20 
Intervention Design and Content - The MSM Intervention, Preparing for your Lung Cancer 
Surgery, is a nurse-led, caregiver-based, multimedia intervention. The intervention coaches lung 
cancer FCGs on pre- and post-operative caregiving skills building and managing their own QOL 
needs.61 The current literature provides evidence that FCGs suffer from symptoms such as sleep 
disturbance and fatigue, forget to manage their own healthcare, and have decreasing ability to 
cope with the stresses of caregiving.73-76 In addition, the MSM Intervention also targets FCG-
patient dyadic knowledge and self-management skills in preparing for surgery and post-operative 
recovery activities. The intervention uses a multimedia approach (15 minute video + handbook – 
available in English or Chinese) to facilitate intervention delivery. Content in the video and 
handbook are identical. The video specifically re-enforces content that involves skills building 
for postoperative recovery activities and caregiving (e.g. step-by-step instructions on using an 
incentive spirometer (IS) for deep breathing exercises).  

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The MSM Intervention is divided into five sessions, provided before surgery, before 
discharge, and at day 2, 7, and 2-months post-discharge (Table 1). Intervention doses are based 
on current evidence for pre-operative educational support in breast, cardiothoracic, and 
orthopedic surgery77-81, and established post-operative recovery activities that are associated with 
outcomes (pulmonary exercise, early ambulation).82, 83 Session 1 focuses on what to expect 
before surgery and during hospitalization after surgery. The information is first presented in an 8 
minute video viewed by both FCGs and patients through provided ipads, followed by goal 
setting and self-management skills coaching using the handbook. Coaching and self-management 
skills assessment will be focused on caregiving skills to support patient post-operative recovery 
as well as skills to manage caregivers own QOL needs. FCGs will learn about the importance of 
managing their own physical and psychosocial well-being (anxiety, roles and relationships, 
social support). FCGs will also be coached on using problem-solving skills to enhance 
preparedness in caregiving. Problem solving skills coaching involves identification of perceived 
barriers to caregiving, prior plans or strategies to overcome these barriers, and identification of 
new strategies to facilitate caregiving responsibilities. Together as a dyad, FCGs and patients 
will learn about what to expect before and after surgery (understanding lung cancer surgery, 
importance of tobacco cessation, breathing exercises using an IS, physical activity, coping with 
Table 1. “Preparing for Your Lung Cancer Surgery” – MSM Intervention Content 
Component 
Family Caregiver Content 
Caregiver-Patient Content 
Session 1 
(before surgery) 
 
• What to expect before 
surgery 
 
• What to expect day of 
surgery 
 
• What to expect after 
surgery 
• Goal Setting 
• Importance of FCG self-
care 
• Managing FCG 
psychosocial well-being 
• Problem solving coping 
skills 
• Understanding your surgery 
• Tobacco cessation 
• Breathing exercise (incentive 
spirometer) 
• Physical activity before surgery 
• Coping with anxiety 
• Day of surgery admissions information 
• Pain assessment and management 
• Chest tube 
• Breathing exercise (incentive 
spirometer) 
• Early ambulation 
• Daily self-monitoring plan 
Session 2 
(before discharge) 
 
• What to expect after 
discharge (Healing at 
home) 
• Goal Setting 
• Managing FCG physical 
well-being 
• Managing FCG healthcare 
needs 
• National and local cancer 
support services 
• Recognizing and managing symptoms 
and medications at home 
• Pain assessment and management 
• Cough and breathing 
• Nutrition 
• Physical activities, intimacy, return to 
work 
• Sleep disturbance 
• When to call your doctor 
 
Sessions 3, 4, 5 
(days 2, 7, 2-months post-
discharge 
• RN Videoconference  
Support 
• Re-enforce problem-solving 
and self-management skills 
• Assess FCG QOL needs 
• Review goals 
• Re-enforce self-management skills 
• Assess patient symptoms and QOL 
needs 

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anxiety, day of surgery information). Dyadic content for what to expect after surgery focuses on 
promoting postoperative recovery activities (pain assessment and management, use of IS and 
breathing exercises, early ambulation). Patients, along with FCG participation, will complete 
daily self-monitoring on pain severity, frequency of deep breathing exercises, and frequency of 
ambulation during hospitalization. 
Session 2 focuses on what to expect after discharge and will be delivered within 24 hours 
of discharge. If patients are discharged from hospital over the weekend, participants will only 
view the video before discharge. A separate telephone call will be scheduled for Monday 
morning with the Research Nurse to deliver the rest of the content for Session 2.  Session 2 video 
lasts 7 minutes, and will be followed by goal setting and self-management skills coaching using 
the handbook. FCGs will learn about tending to their own physical well-being and healthcare 
needs. Physical symptoms of caregiving, such as sleep disturbance and fatigue, will also be 
addressed. FCGs will receive content on managing their own healthcare needs (medications, co-
morbid conditions, doctor’s appointments). National and local cancer support services for FCGs 
will be provided.  Dyadic content will re-enforce postoperative recovery activities to be 
continued at home (recognizing and managing symptoms, medications at home, pain assessment 
and management, breathing exercises, physical activity). Common postoperative symptoms, such 
as cough, dyspnea, fatigue, and sleep disturbance will be reviewed. Content also addresses 
nutrition, intimacy, return to work, and when to contact the surgical team. 
Participants will be able to view the videos at home after initial viewings during Sessions 
1 and 2. Videos will be accessible through a trial-specific secure website made available only to 
participants randomized to the MSM Intervention group. The website will be accessible via 
computers, smartphones, or tablets. 
Sessions 3, 4, and 5 involves three RN support sessions after discharge through telephone 
calls (separate sessions for FCGs and patients). During these sessions, the Research Nurse will 
re-enforce problem-solving approaches with the FCGs and self-management with both FCGs and 
patients. They will also review goals, assess the participants’ QOL needs and facilitate any care 
coordination and communication with the surgical team as needed. Based on our pilot study 
experience, the estimated time to complete sessions 1 and 2 is about 40-60 minutes (video 
viewing and RN coaching). Each videoconference (sessions 3, 4, 5) will last 20-30 minutes. 
 
Study Procedures - The Experimental Design Schema on page 2 of the protocol provides the 
study schema for this trial.  
For the MSM Intervention group, Session 1 video will be viewed by FCGs and patients 
approximately 3-7 days before surgery. The video will be delivered during a routine clinic visit 
in the pre-anesthesia clinic. If needed, the video can be administered remotely. Participants will 
receive the handbook (English or Chinese) either in person or by mail following viewing, and the 
Research Nurse will coach participants on session 1 content, and answer any questions related to 
the MSM Intervention. After surgery, FCGs/patients will view the Session 2 video within 24 
hours of planned discharge. Session 2 video can be administered in person or remotely by 
internet and telephone. In addition, nurses in 4 West will also be able to show session 2 video to 
participants. Handbook content will be reviewed, and the Research Nurse will coach participants 
on completing daily self-monitoring during hospitalization. For participants discharged over the 
weekend, they will view Session 2 video before discharge, and receive a scheduled call Monday 
morning with the Research Nurse to review rest of the content for Session 2.  Outcomes will be 
re-assessed at discharge. Research Nurse will complete Sessions 3, 4, and 5 of the MSM 

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Intervention (RN telephone support) at day 2, day 7, and 2 months post-discharge. Outcomes 
will be re-assessed at 1-month and 3-months post-discharge.  
 
For the attention control group, FCGs and patients will view Session 1 video (American 
Cancer Society video on “Clinical Trials”) approximately 3-7 days before surgery. This will be 
delivered during a routine clinic visit in the pre-anesthesia clinic. If needed, the video can be 
administered remotely. Participants will receive American Cancer Society print materials either 
in person or by mail on the topic following viewing, and the CRA will answer any questions 
related to the materials. After surgery, participants will view Session 2 video (American Cancer 
Society video on “Clinical Trials”) within 24 hours of planned discharge. Session 2 video can be 
administered in person or remotely by internet and telephone. In addition, nurses in 4 West will 
also be able to show session 2 video to participants. American Cancer Society print materials on 
the topic will be reviewed, and the CRA will answer any questions related to the materials. All 
videos and written materials are available in English and Chinese. Three telephone calls at day 2, 
day 7, and 2 months post-discharge will be initiated by the CRA. During these calls, the CRA 
will ask participants if they have any questions with the American Cancer Society materials. 
Outcome assessments will be the same as the MSM Intervention group.  
For lung cancer surgery, a 3-month follow-up is the most appropriate time period to 
address the main outcomes in this study. From a patient QOL perspective, pulmonary function 
declines immediately after surgery, but continues to improve for about 3 months afterwards.15 
Beyond that point, respiratory capacity plateaus, such that the lung function 3 months after lung 
cancer surgery closely approximates the permanent status of the patient. In terms of healthcare 
resource use, about half of readmissions occur within 30 days, but almost an equal number of 
readmissions occur between 30 and 90 days.17 In addition, the 90 day period after major surgery 
is included in the “global surgical package” by the Centers for Medicare and Medicaid Services 
(CMS), which reflects the period of time that should be considered the peri-operative period.84  
Several approaches are included to ensure intervention rigor and prevent experimental 
drift. Design for establishing intervention fidelity is guided by the Technology Model of 
Intervention Fidelity.85-87 First, interventionist manual will be developed to layout intervention 
goals, and strategies to achieve these goals. Second, training and supervision of the Research 
Nurse and CRAs will be undertaken. Third, intervention fidelity will be monitored during study 
implementation using an intervention fidelity measure. The PI will monitor intervention fidelity. 
Rigor will be established by double-coding of monitoring results. When study accrual begins, 
sessions for the first 5 participants will be tape-recorded and every 10th session thereafter will be 
recorded and reviewed by the PI. Fidelity issues and review results will be discussed with the 
research staff during team meetings. 
 
 
5.2 
Planned Duration of Therapy 
Study participation is planned for approximately 3-4 months. The timeframe covers 
before surgery, postop acute care, and 3 months post-discharge.   
 
5.3 
Criteria for Removal from Treatment 
The only criterion for disenrollment is if participants desire to discontinue with study 
participation. 

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5.4 
Subject Follow-Up 
Subjects will be followed for approximately 3 months. 
  
5.5 
Supportive Care, Other Concomitant Therapy, Prohibited Medications 
The Research Nurse and CRAs will review participant’s responses to all self-reported 
outcome measures and alert the attending thoracic surgeon if participants show risk of self-harm 
or other serious conditions. These participants will be referred to supportive care and social work 
as necessary after evaluation by the attending surgeon. Otherwise, there are no restrictions to the 
use of supportive care medications, other concomitant therapy and no prohibited medications.  
 
5.6 
Additional Studies 
Patients enrolled in the study will be consented to provide permission to access their 
routine CT scans for future research purposes. The future use involves improving the knowledge 
on accurate methods of measuring muscle mass. The study will access routine CT scans before 
surgery and scans at 6-months after surgery. Patients will not incur additional costs or harms 
because only routine CT scans completed for treatment preparation and for follow-up will be 
used.  
All outcome measures, as described below, are available and validated in both English 
and Chinese.  
 
FCGs and patients will also complete Geriatric Assessments (GA), available in both 
English and Chinese. All participants, regardless of age, will complete GA throughout the study. 
In our previous Program Project grant in lung cancer, we had completed GA for all patients, 
regardless of age. Many key components of the GA (such as comorbidities, social support, social 
activity, weight loss, body mass index) are relevant outcomes to consider for all surgical patients, 
regardless of age. In addition, we anticipate that many FCGs will be older. Our administration of 
the GA in FCGs is exploratory, and will provide an innovative approach to expand the utility of 
GA in oncology. 
The Geriatric Assessment (GA) Tool developed by Hurria and colleagues is composed of 
a group of instruments, some of which are completed by the research staff and some by the 
patient.  Each of these is described below.  Time for patients to complete the group of 
questionnaires is 27 minutes.88, 89 
1) Instrumental Activities of Daily Living (IADL): [subscale of the Older American Resources 
and Services (OARS)]The OARS Multidimensional Functional Assessment Questionnaire 
(MFAQ) was developed to provide a profile of the level of functioning and need for services of 
older persons who live at home but may have some degree of impairment. The MFAQ has been 
tested on over 6,000 older community residents.90 The Instrumental Activities of Daily Living 
(IADL) subscale consists of 7 questions rated on a three-point Likert scale of degree to which the 
activity can be performed independently. Norms are available for the MFAQ based on 2,146 
elderly community residents.90  
2) Activities of Daily Living: [subscale of Medical Outcomes Study (MOS) Physical Health] The 
MOS Physical Health Scale contains measures of higher levels of physical functioning than 

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those described in other activities of daily living scales. The variation in functioning among 
healthier patients in the study will be examined through asking about higher order functioning. 
The scale includes items on vigorous activities (running, lifting heavy items) as well as basic 
activities (bathing and dressing). The 10 items are rated on a three-point Likert scale of 
independent performance of the activity. At least six items must be answered to obtain a total 
score. A total score is created by summing the item scores and transforming them to range from 
0 to 100. Internal consistency of the physical function score is high at 0.92.91 
3) Karnofsky Physician-Rated Performance Rating Scale (KPS): The Karnofsky Performance 
Status, has been widely used in the evaluation of cancer patients.92 It is a general measure of 
patient independence in carrying out normal activities. Patients are given a score on a numerical 
scale of 0-100 as a global indicator of functional status. Studies on inter-rater reliability between 
nurse and social worker KPS ratings indicate good correlation (r = 0.69, p<.001). KPS was most 
strongly correlated with variables related to physical functioning (difficulty with stairs: r = 0.63; 
difficulty with balance: r = 0.61).93  
4) Timed Up & Go: The timed “up and go” is a test of physical mobility. The test, measured in 
seconds, is the time it takes for an individual to stand up from a standard arm-chair (approximate 
seat height of 46 cm), walk a distance of 3 meters (10 feet), turn, walk back to the chair, and sit 
down again. Intra-rater and inter-rater reliability was extremely high (intra-class correlation 
0.99). Performance on the timed “up and go” test significantly correlated with scores of other 
performance measures including Berg Balance Scale (r = -0.81), gait speed (r = -0.61), and 
Barthel Index of ADL (r = -0.78).  
5) Number of Falls in Last 6 Months: Older patients are at risk for falls and injury secondary to 
falls because of gait and balance impairments. In patients with cancer the risk is even greater for 
a number of reasons. First, bony metastases may place them at risk of a pathologic fracture with 
falls. Secondly, patients receiving chemotherapy may have a low platelet count which puts them 
at greater risk of hemorrhage. Lastly, commonly used chemotherapy drugs may have neurologic 
complications resulting in falls. For example, paclitaxel and cisplatin may cause neuropathy, 
fluorouracil and cytarabine may cause cerebellar toxicity. For these reasons, knowing a patient’s 
risk of falling before treatment could help providers make treatment decisions.  
6) Physical Health Section [subscale of The Older American Resources and Services 
Questionnaire (OARS)]: The OARS Physical Health Section is a comorbidity scale which 
contains a list of concurrent illnesses and the degree to which they impair daily activities, rated 
on a three-point scale of “not at all” to “a great deal.” Medication use is recorded. Test-retest 
reliability was good (r=.66) over a five-week period. In terms of validity, the Physical Health 
subscale correlated significantly with health professional ratings (Kendall's tau co-efficient 
=.75). We will also capture the patient’s medication list, so as to confirm that the comorbidity list 
reported by the patient is complete. 
7) Blessed Orientation-Memory-Concentration Test: The BOMC consists of 6 questions 
designed to screen for gross cognitive impairment. A score >11 signifies cognitive impairment. 
The test-retest reliability is high (Spearman Rank Correlation 0.96; p < 0.001). The BOMC has 
excellent validity as a screening instrument, correlates highly with clinicians' ratings of dementia 
severity (r=0.89), predicts results from a longer (26 item) mental status questionnaire, and 
discriminates between patients with mild, moderate, and severe cognitive deficits.  
8) Hospital Anxiety and Depression Scale (HADS):The Hospital Anxiety and Depression Scale 
(HADS) is a 14-item self-administered measure that has been well tested in cancer populations. 
It has two 7-item subscales that assess depression and anxiety. The scale is considered 

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particularly appropriate for use with medically ill patients because of the absence of somatic 
items that often confound the determination of psychiatric problems in a medically ill population. 
Reported anxiety and depression cutoff scores on the HADS have varied from 8 to 11. The total 
cutoff score for psychological distress has ranged from 13, reflecting adjustment disorder, to 19, 
reflecting major depressive disorders. Ibbotson and colleagues found that an overall cutoff score 
of 15 or greater resulted in 80% sensitivity, 76% specificity, and a positive predictive value of 
41% for psychological distress.94  
9) Medical Outcomes Study (MOS) Social Activity Limitations Measure: The impact of cancer 
on patients’ social functioning will be assessed by the Social Activity Limitations scale from the 
Medical Outcome Study (MOS).91 As with all MOS measures, the Social Activity Limitations 
scale was developed from a national sample of medically ill patients being treated in outpatient 
facilities. The four-item scale assesses the extent to which physical or emotional problems have 
interfered with social activities. All items are rated on a 5-point Likert scale, with response 
categories varying with each item. The mean of the total score is transformed to a scale of 0-100, 
with a higher number indicating greater support. Internal consistency was good (alpha coefficient 
= .77). The scale correlates significantly with a range of measures: role limitations due to 
physical (r= .52) and emotional (r = .49) health, psychological distress (r= .64) and pain (r = .55).  
10) Medical Outcomes Study (MOS) Social Support Survey: Emotional/Information and 
Tangible Subscales: This is a 20-item measure of social support, with four subscales: 
emotional/informational, tangible, affectionate, and positive social interactions. The scale was 
developed as part of the Medical Outcome Study, tested on 2987 patients, and designed to assess 
quality of life across medical conditions. In this study, we use the Tangible (access to material 
aid or behavioral assistance) and Emotional/Information (the expression of positive affect and 
empathetic understanding; the offering of advice, information, guidance, or feedback) subscales. 
All but one item is rated on a five-point Likert scale from “None of the Time” to “All of the 
Time.” Internal consistency of the subscales and total score are excellent (alpha coefficient > 
0.91). Convergent validity was demonstrated by significant correlations of social support total 
score with measures of mental health (r =.45).91  
11) Percent Unintentional Weight Loss: Patients will be asked to quantify the amount of 
unintentional weight loss in the past 6 months and to record their baseline body weight 6 months 
ago. The following is the calculation for % unintentional weight loss: unintentional weight lost in 
last six months = (unintentional weight loss in last 6 months/baseline body weight) x100. 
12) Body Mass Index: Weight and height will be measured in order to calculate body mass index, 
by the following formula: 
   
 
Weight in kg 
BMI   = 
 
 
 
 
 
 
 
 
Height in m2 
 The assessments will be completed in-person on an iPad during a routine clinic visit, or 
by telephone. Patients will complete GA at baseline, first postoperative clinic visit, and 3 
months. FCGs will complete GA at baseline and 3 months).  
 
13) Mini-Cog: The mini-cog is a validated tool recommended for use to assess Chinese speaking 
participants in place of the blessed-orientation-memory-concentration test. A score of <3 is a 
validated cut off for dementia screening, although a score of <4 may be used for more sensitive 
screening of cognitive impairment.  

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COVID-19 Questions- These questions will be asked 1 month post-discharge to obtain 
qualitative data from patients and FCGs on the impact of the COVID-19 pandemic. FCGs and 
patients will provide answers separately. We will only collect this data going forth with newly 
enrolled patients/FCGs. We will not ask patients/FCGs already enrolled in the study to complete 
the questions.  
COVID-19 Interview Questions for Healthcare Professionals – These interview questions 
will be used to obtain qualitative data from thoracic surgeons and thoracic surgery nurse 
practitioners on the impact of COVID-19 on cancer care. Interviews will be conducted 
individually with each surgeon/NP (total = 5).  Interviews will be conducted once only.  
Social Determinants of Health (SDH) – Key Informant Interviews: Six participants (3 
FCGs, 3 patients) will be invited to participate in individual (Key Informant) interviews. The 
purpose of the 6 interviews is to inform the development of the interview guide to determine 
social determinants of health-related needs of FCGs/patients in relation to lung cancer surgery. A 
total of 30 participants (15 FCGs, 15 patients) will then be invited to participate in individual 
(Key Informant) interviews. A total of 36 FCGs/patients (3 FCG/patient dyads) will be randomly 
invited to participate in six focus groups. Open-ended questions will be used to garner 
discussions around SDH and QOL outcomes for FCGs and patients.  
Invitation letters will be sent to potential participants via email and postal mail; the letters 
will instruct interested participants to contact the investigators (Dr. Teteh). Each key informant 
interview will last approximately 30 minutes and each focus group session will last 
approximately 60 minutes. Both will be conducted via Zoom or MS Teams videoconferencing to 
minimize travel burden for participants. Set-up for the Zoom/MS Teams system and instructions 
for use will be provided prior to each interview.  Only newly enrolled dyads after IRB approval 
will be invited to participate in the interviews. Dyads that are already enrolled will not be invited.  
Social Determinants of Health (SDH) – Quantitative Survey: FCGs and patients will 
complete the following questionnaire about the impact of social determinants of health. For 
English-speaking participants who enrolled in the study but did not complete the SDH 
quantitative survey, they will be retrospectively invited to complete the survey at one time only. 
Participants will be consented using IRB approved addendum consents before survey 
completion.  
Protocol for Responding to and Assessing Patients’ Assets, Risks, and Experiences 
(PRAPARE)95: This 21-item instrument measures SDH domains for patients related to 
environment, economic stability and social and emotional health factors. PRAPARE is a 
standardized patient and social risk assessment tool informed by research on SDH and aligns 
with national initiatives (e.g. Department of Health and Human Services’ Healthy People 2020), 
federal reporting requirements, and International Classification of Diseases-10 clinical coding 
system. 
Spiritual Well-Being – Quantitative Survey:  Patients will complete the following 
questionnaire about spiritual well-being. For English-speaking participants who enrolled in the 
study but did not complete the Spiritual Well-Being quantitative survey, they will be 
retrospectively invited to complete the survey at one time only. Participants will be consented 
using IRB approved addendum consents before survey completion.  
 

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Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12):  
This 12-item tool assesses a patient’s spiritual well-being using a 5-point Likert scale. FACIT-
Sp-12 measures sense of meaning and peace (8-item subscale), and the role of faith in illness (4-
item subscale). The internal consistency ranges from 0.81 to 0.88 for the total scale and 
subscales. Items score ranges from 0 to 48 and a higher score indicates better spiritual well-
being. The tool was previously tested in a sample of lung cancer patients.96 FCGs will not 
complete the survey. 
5.6.1 Laboratory Studies 
Not Applicable 
 
5.7 
Definition of Dose-Limiting Toxicity (DLT) 
Not Applicable 
 
6.0 
Dose Delays/Modifications for Adverse Events 
Not Applicable. 
 
7.0 
Data and Safety Monitoring, Unanticipated Problems and Adverse 
Event Reporting 
7.1 
Data and Safety Monitoring 
Definition of Risk Level 
This is a Risk Level 1 study, as defined in the City of Hope Institutional Data and Safety 
Monitoring Plan [policy effective date:  07/09/14], because it involves an educational/behavioral 
intervention and surveys.  
 
7.2 
Monitoring and Personnel Responsible for Monitoring 
 
The Principal Investigator (PI) is responsible for monitoring protocol conduct and 
reporting to the City of Hope (COH) Data and Safety Monitoring Committee (DSMC) and 
Institutional Review Board (IRB) as indicated in the sections below. 
 
7.3 
Unanticipated Problems (UP)  Involving Risks to Subjects or Others 
An unanticipated problem is any incident, experience or outcome that meets all three of 
the following criteria: 
1. Unexpected (in terms of  nature, severity, or frequency) given the following: a) the 
research procedures that are described in the protocol-related documents such as the IRB 
approved research protocol, informed consent document or Investigator Brochure (IB); 
and b) the characteristics of the subject population being studied; AND 
2. Related or possibly related to participation in the research (possibly related means there is 
a reasonable possibility that the incident, experience, or outcomes may have been caused 
by the procedures involved in the research); AND 

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3. Suggests that the research places participants or others at greater risk of harm (including 
physical, psychological, economic, or social harm) than previously known or recognized. 
 
Any UP that occurs during the study conduct will be reported to the DSMC and IRB in 
accordance with the City of Hope’s Institutional policy [policy effective date:  05/14/14] using the 
electronic submission system, iRIS. 
 
7.4 
Deviations 
A deviation is a divergence from a specific element of a protocol and that occurred without prior 
IRB approval.  Deviations from the approved protocol should be avoided, except when necessary 
to eliminate an immediate hazard to a research participant.  A Corrective and Preventative 
Action (CAPA) plan should be developed by the study staff and implemented promptly to avoid 
similar issues in the future.  All deviations from the protocol must be documented in study 
source documents and promptly reported to the DSMC and IRB.   
 
Reporting Deviations 
Investigators may deviate from the protocol to eliminate immediate hazards for the protection, 
safety, and well-being of the study subjects without prior IRB approval.  For any such deviation, 
the PI will notify the DSMC and IRB, within 5 calendar days of its occurrence by electronic 
submission of a Deviation Notice via iRIS. 
 
Single Subject Exception (SSE) Amendment Request 
Deviations from the written protocol that are not done to eliminate an immediate hazard(s) for 
the protection, safety and well-being of study subjects but may increase risk and/or alter the 
protocol integrity require prior IRB approval.  The deviation is submitted as a Single Subject 
Exception (SSE) amendment request.  An IRB approved SSE does not need to be submitted as a 
protocol deviation to the DSMC.  The SSE should be submitted according to the IRB guidelines 
and Clinical Research Protocol Deviation policy [policy effective date:  11/07/11] and submitted 
via iRIS. 
 
A deviation that is not an SSE (i.e., discovered after the occurrence) must be reported to the 
COH DSMC and IRB according to the Clinical Research Protocol Deviation policy [policy 
effective date:  11/07/11] and submitted via iRIS. 
 
 
8.0 
Agent Information and Risks 
Not Applicable. 
 
9.0 
Correlative/Special Studies 
No correlative studies will be performed during this trial.

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10.0 Study Calendar 
 
 
Baseline Before 
Surgery Treatment 
Before  
Discharge 
Day 2 Post-
Discharge 
Day 7 Post-
Discharge 
 
First Postop 
Clinic Visit 
1 Month 
Post- 
Discharge 
2 Month 
Post-
Discharge 
3 Month 
Post-
Discharge 
Informed Consent 
R 
 
 
 
 
 
 
 
 
 
Baseline Assessment 
R 
 
 
 
 
 
 
 
 
 
*Intervention – Session 1 
 
R 
 
 
 
 
 
 
 
 
SURGERY 
 
 
X 
 
 
 
 
 
 
 
*Intervention – Session 2 
(note: for participants 
discharged over the weekend, 
video will be viewed before 
discharge, and rest of the 
session will be delivered via 
phone on Monday morning 
 
 
 
R 
 
 
 
 
 
 
Before Discharge Assessment 
 
 
 
R 
 
 
 
 
 
 
*Intervention – Session 3 
 
 
 
 
R 
 
 
 
 
 
*Intervention – Session 4 
 
 
 
 
 
R 
 
 
 
 
1 Month Post-Discharge 
Assessment 
 
 
 
 
 
 
 
R 
 
 
*Intervention – Session 5 
 
 
 
 
 
 
 
 
R 
 
3 Month Post-Discharge 
Assessment 
 
 
 
 
 
 
 
 
 
R 
Geriatric Assessment (FCGs) 
R 
 
 
 
 
 
 
 
 
R 
Geriatric Assessment 
(Patients) 
R 
 
 
 
 
 
R 
 
 
R 
Social Determinant of Health 
Questionnaire (Patients) 
R 
 
 
 
 
 
 
 
 
 

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Social Determinants of 
Health Questionnaire (FCGs) 
R 
 
 
 
 
 
 
 
 
 
Spiritual Well-Being 
(Patients only) 
R 
 
 
 
 
 
 
 
 
R 
* Will only be administered to subjects in MSM intervention group

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11.0 Endpoint Evaluation Criteria/Measurement of Effect 
11.1Response Criteria 
Not Applicable. 
 
12.0 Data Reporting/Protocol Deviations 
12.1Data Reporting 
12.1.1 Confidentiality and Storage of Records 
A REDCap database will be developed by COH’s Research Informatics for this study. 
All completed outcome surveys will stored electronically in the REDCap database. The database 
is passcode-protected, and only the PIs and research staff will have access to the REDCap 
database. Recordings of key informant and focus group interviews will be stored in the City of 
Hope firewall protected network. Only the PIs and research staff will have access to the 
recordings. These recordings will be transcribed for data analysis purposes and then deleted after 
completion of the study. When results of this study are reported in medical journals or at 
meetings, identification of those taking part will not be disclosed.  Medical records of subjects 
will be securely maintained in the strictest confidence, according to current legal requirements.  
They will be made available for review, as required by the FDA, HHS, or other authorized users 
such as the NCI, under the guidelines established by the Federal Privacy Act and rules for the 
protection of human subjects. 
 
12.1.2 Subject Consent Form 
Initial verbal consenting will only be used when potential participants are not in the 
clinic. In these situations, the Research Nurse and CRA will use the approved information sheet 
(available in both English and Chinese) for verbal consent process. An informed consent 
(available in both English and Chinese) will then be obtained either in writing in person, by mail, 
or electronic mail, or electronically via other electronic applications (i.e. DocuSignTM). 
Otherwise, all participants will complete either a written or electronic informed consent (i.e. 
DocuSignTM) prior to study participation. The study will use one written or electronic informed 
consent (with signature line) and one information sheet (without signature line) for FCGs, and 
one written or electronic informed consent (with signature line) and one information sheet 
(without signature line) for patients.  Documentation of initial verbal consent for study 
participation will be charted through progress notes and maintained in the patients’ electronic 
medical records as required by the Institutional Review Board.  
 
12.1.3 Data Collection Forms and Submission Schedule 
Table 2 provides outcome measures and the corresponding evaluation time points. All 
outcome measures completed by patients/FCGs are available and validated in both English and 
Chinese. We will collect sociodemographic and health status data (e.g. age, sex, race/ethnicity, 
education, employment, relationship to patient, religious preference, marital status, living 

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situation, income, co-morbidities, and tobacco history) for both FCGs and patients at baseline. 
Outcomes are assessed at baseline (before surgery), discharge, 1 month, and 3-months post-
discharge. They will take about 30 to 45 minutes to complete. Outcomes were selected based on 
our conceptual model, previous research in lung cancer, and recommendations on common data 
elements for self-management research.97 
  
Family Caregivers: 
 Distress Thermometer (DT) – The DT is an efficient, low subject burden measure to evaluate 
psychological distress over the past week, based on a scale of 0 (no distress) to 10 (extremely 
distressed). According to the National Comprehensive Cancer Network (NCCN), psychological 
distress is defined as mixed anxiety and depression symptoms.98 A cut-off of 3/10 indicates a 
need for intervention, with acceptable sensitivity (94.1%) and specificity (71.2%) compared to 
Table 2. Outcome Measures by Aims and Assessment Time Points 
 
Measures 
Baseline 
Discharge 
1 month 
3 months 
Family 
Caregivers 
Distress Thermometer 
x 
x 
x 
x 
Montgomery Borgatta Caregiver Burden 
Scale 
x 
x 
x 
x 
Preparedness for Caregiving Scale 
x 
x 
x 
x 
COH-QOL-Family 
x 
x 
x 
x 
Family Caregiver Healthcare Use Survey 
 
x 
x 
x 
Patients 
 
Distress Thermometer 
x 
x 
x 
x 
FACT-L 
x 
x 
x 
x 
Patient Healthcare Use Survey (non-COH) 
 
 
x 
x 
Medical Chart Audit Form 
 
 
 
x 
Outcome 
Mediators 
Family Caregiver Activation in Transitions 
(FCAT) Tool 
x 
x 
x 
x 
Patient Activation Measure (PAM) 
x 
x 
x 
x 
Self-Efficacy Scale 
x 
x 
x 
x 
Surgery-Related  Knowledge Tool 
x 
x 
x 
x 
Exploratory 
Sociodemographic and Health Status 
x 
 
 
 
STS General Thoracic Surgery Data 
Collection Form 
 
 
 
x 
Exit Interview Discussion Guide 
 
 
 
x 
Process 
RN Debriefing Form 
After each intervention session 
Intervention Fidelity Checklist 
1st five participants and every 10th session 
thereafter 

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the Hospital Anxiety and Depression Scale (HADS).71 The DT has been validated in FCGs, with 
receiver operating characteristics (ROC) of 0.88 relative to the HADS.71, 99 It is also validated in 
lung cancer patients.70  
Montgomery Borgatta Caregiver Burden Scale (MBCBS) – This 14-item tool was designed to 
measure the impact of caregiving on three dimensions of burden: objective, subjective demand, 
and subjective stress. Internal consistency for the three dimensions ranges from .81 to .90.100 The 
ordinal scale ranges from 1-5 (a lot less to a lot more). The following cutoff scores are 
interpreted as high burden: 1) a score of 23 or > for objective burden, 2) a score of 15 or > for 
subjective demand, and 3) a score of 13.5 or > for subjective stress.  
Preparedness for Caregiving Scale – This is an 8-item scale of the Family Care Inventory by 
Archbold and colleagues.101 Items are scored from 0 to 4, with higher scores indicating better 
preparedness.  A mean score is tabulated for all items. Internal consistency ranges from 0.88 to 
0.93.102, 103   
City of Hope-Quality of Life–Family (COH-QOL-Family) – This is a 37-item instrument that 
measures the FCG QOL in the physical, psychological, social, and spiritual well-being domains. 
Ordinal scale ranges from 0-10, with higher scores indicating better QOL. The instrument was 
revised and tested from 1994-1998 in a study of 219 FCGs of cancer patients. The test-retest 
reliability was r=.89 and internal consistency was alpha r=.69.104, 105 
Family Caregiver Healthcare Use Inventory – This is a self-report measure of 4 yes/no items on 
cancer support services use (social work referrals, family resource center use). This inventory 
was adapted from Given and colleagues106 and Meneses and colleagues.107  
 
Patients: 
Distress Thermometer (DT) – this is the same measure used to assess FCG psychological 
distress. 
Functional Assessment of Cancer Therapy-Lung (FACT-L) - The FACT-L is a cancer specific 
version of the FACIT System developed specifically for lung cancer. It contains the FACT-G 
scales with 27-items divided into physical, social/family, emotional, and functional well-being 
domains. A 10-item disease-specific symptom index (LCS) is included. For each item, the 
respondent indicates on a 5-point Likert scale (0=not at all; 4=very much) how true each 
statement is during the past 7 days.  Reliability was tested in 116 lung cancer patients. 
Cronbach’s alpha for the FACT-L is 0.89.108 A 2 to 3 point change in scores for the FACT-L 
subscales is considered to be the minimal clinically important difference (MCID).109 
Medical Chart Audit Form – This form will be used to record healthcare resource use provided at 
the cancer center as documented in electronic medical records (EHR). These include in-home 
nursing care, urgent care/ER visits, and 30 and 90-day hospital readmissions.   
Patient Healthcare Use Inventory – This is a self-report measure of 23 yes/no items on non-COH 
healthcare resource use (hospital admissions, urgent care/ER visits, support services visits). It 
was adapted from Given and colleagues106 and Meneses and colleagues.107 McCorkle and 
colleagues used a similar method for an intervention study, and reported a 95% agreement 
between patient self-report data and medical chart audits.110 
 
Outcome Mediators: 
FCG Activation in Transitions Tool (FCAT) – This 10-item survey was designed to assess 
FCG’s level of engagement and preparedness to care for patients during care transitions. 
Psychometric assessment was conducted in two randomly equivalent waves of participants 

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(N=434), including FCGs of patients with cancer and/or chronic lung disease. The estimated 
person-separation reliability was 0.84.111  
Patient Activation Measure (PAM) – This measure assesses patient “activation”, which uses a 
Guttman-like scale that reflects a patient’s level of engagement and empowerment in their 
healthcare.112 Cronbach’s alpha from our pilot study was 0.92. 
Self-Efficacy Scale - This tool is a modified version of the Self-Efficacy Scale developed by 
Lorig and colleagues.113 It contains 8 items that assesses FCG’s and patient’s perceived 
confidence in self-management. Items are rated on a 4-point Likert scale, and higher scores 
represent higher confidence. Cronbach’s alpha from our pilot study was 0.89.  
Surgery-Related Knowledge Tool - This tool was developed by the investigators to assess FCG 
and patient post-operative recovery knowledge. Each item addresses specific content within the 
MSM intervention to assess changes in knowledge. Scoring is based on the number of questions 
answered correctly. 
 
Exploratory: 
Society of Thoracic Surgeons General Thoracic Surgery Database Data Collection Form – This 
form will be used to record clinical and surgical characteristics. These include date of diagnosis, 
pre-operative risk factors, pre-operative treatments, pre-operative pulmonary function tests, date 
of surgery, type of surgical procedures, admission date and status, clinical staging, postoperative 
events/complications, discharge date and status, discharge disposition, pathological staging, and 
smoking cessation plans. 
Exit Interview Discussion Guide – Qualitative data will be obtained through semi-structured 
interviews using a discussion guide. The guide contains a series of overarching questions, 
presented in an open-ended fashion. The questions are designed to solicit FCGs’ and patients’ 
experiences with participating in the intervention. FCGs and patients will be interviewed 
separately. 
Key Informant Discussion Guide – This discussion guide will be used to obtain qualitative data 
for the key informant interviews. The questions in this guide will solicit information about 
patient’s and FCG’s living environment, social and community context, economic stability, 
healthcare access and quality, and education. FCGs and patients will be interviewed separately.  
 
Process: We will also include the following process measures to assess intervention 
implementation and fidelity: 
RN Debriefing Form - This form will be used to assess intervention implementation by the 
Research Nurse. It includes 7 scored items and 2 open-ended questions. The form documents 
session length, and assesses, on a scale of 0-10 (0=poorly, 10=very well), the participant’s level 
of intervention participation during each session. 
Intervention Fidelity Checklist – This checklist will be used to monitor intervention fidelity by 
the MPIs and self-management consultant (Dr. McCorkle). Using a present/absent response 
format, each intervention key element will be assessed by determining whether the 
interventionist behaviors were completed. 
 
 
12.1.3.1 
Eligibility Checklist 
No eligibility checklist will be used in this study as the eligibility criteria is short.  
 

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12.1.3.2 
Prior Therapy Forms and On-Study Forms 
No prior therapy forms and on-study forms will be used in this study.  
 
12.2 
 Protocol Deviations 
12.2.1 
Deviation Policy 
This protocol will be conducted in accordance with COH’s “Clinical Research Protocol 
Deviation Policy” located at 
http://www.coh.org/dsmc/Documents/Institutional%20Deviation%20Policy.pdf. 
Deviations from the written protocol that could increase patient risk or alter protocol 
integrity require prior IRB approval of a single subject exception (SSE) request.  In addition, if 
contractually obligated, the sponsor must also approve the deviation.  IRB pre-approved SSE 
protocol modifications are considered an amendment to the protocol and not a deviation.  The 
submission of a deviation report is not required. 
Brief interruptions and delays may occasionally be required due to travel delays, airport 
closure, inclement weather, family responsibilities, security alerts, government holidays, etc.  
This can also extend to complications of disease or unrelated medical illnesses not related to 
disease progression.  The PI has the discretion to deviate from the protocol when necessary so 
long as such deviation does not threaten patient safety or protocol scientific integrity.  Examples 
include, but are not limited to:  a) dose adjustments based on excessive patient weight; b) 
alteration in treatment schedule due to non-availability of the research participant for treatment; 
c) laboratory test results which are slightly outside the protocol requirements but at levels that do 
not affect participant safety.  These instances are considered to be deviations from the protocol.  
A deviation report will be submitted to the DSMC/IRB within five days. 
 
12.2.2 
Reporting of Deviations 
All deviations will be reported to the COH DSMC within five days.  The DSMC will 
forward to report to the IRB following review. 
 
12.2.3 
Resolving Disputes 
The COH Investigational Drug Service (IDS) cannot release a research agent that would 
cause a protocol deviation without approval by the PI.  Whenever the protocol is ambiguous on a 
key point, the IDS should rely on the PI to clarify the issue. 
In situations where there is misperception or dispute regarding a protocol deviation 
among the persons involved in implementing the protocol, it is the responsibility of the PI to 
resolve the dispute and the PI may consult with the DSMC chair (or designee) to arrive at 
resolution. 
 

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13.0 Statistical Considerations 
13.1Study Design 
Our target sample size for this study will be 200 caregiver-patient dyads (after 20% 
attrition). The planned sample size is 100 caregiver-patient dyads per treatment group.  The 
power of statistical tests (two-sided 0.05 level of significance) is shown below for the primary 
outcomes of each specific aim. The effect sizes are shown as pairs of numbers representing the 
expected control group mean, based on published data, and the hypothetical population mean for 
the intervention care group. The SD column is based on published data, and power is 
conservatively estimated for a simple t-test on a single post-intervention measurement. The 
planned analysis, described in section E.5, will adjust for baseline values, and will combine 
longitudinal assessments, both of which will improve power.   
A total of 80 new cases of stage I-III surgically treated NSCLC were available at City of 
Hope in fiscal year 2015. Our institutional race distribution is 56.2% Caucasian, 20.5% Hispanic, 
4.7% Black, 13.5% Asian, and 5.1% other (38.7% ethnic minorities overall). These statistics 
should reflect the anticipated race distribution for participants. All efforts will be made to accrue 
minorities. Our pilot study demonstrates that we are able to accrue minorities (38%) to match the 
population at City of Hope. 
 
A sample size of 100 per arm was calculated, based primarily on outcome means and 
variation observed in our previous studies (see Section E.1 for sample size calculations and 
power analysis). We have projected attrition based on previous studies. We will enroll 100 
participants per arm to allow for 20% drop-out/attrition during the course of the study. We will 
enroll a total of 200 dyads in order to retain 160 dyads at 3-months. With a 52 month accrual 
plan, we estimate that 4 caregiver-patient dyads will need to be accrued per month. With a total 
pool of 80 potential dyads per year, this yields approximately 7 dyads per month that are eligible 
for the study. Hence, we will have a sufficient pool of eligible participants for study accrual. In 
our lung cancer Program Project (N=366), we were able to enroll 4 FCGs and patients per 
month.59, 114 
We will study FCGs and patients age 21 and over to obtain participants across a spectrum 
of chronological ages. A range of ages is expected although we anticipate at least 68% of 
NSCLC patients will be ≥ 65 years. We anticipate that the majority of FCGs will be spouses and 
≥ 60 years old given the patient age distribution. Based on our experiences, 90% of patients have 
an identified FCG.  We acknowledge that the aging spectrum is heterogeneous and that older 
patients have a higher risk of surgical morbidity.115 We anticipate that the majority of FCGs will 
be female (75%), but expect an equal representation by sex for patients. We recognize that age 
and sex are important influencing factors. We will examine the moderating effect of these 
biological variables on outcomes in Exploratory Aim 1. 

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Specific Aim 1 addresses the effects of the MSM Intervention on FCG outcomes, and 
Table 3 provides FCG outcome effect size and power based on 80 participants per group. 
Hypothesis 1.1 will address FCGs’ psychological distress and burden.  The study by Zwahlen et 
al71 provides distress 
thermometer (DT) 
scores for 306 family 
members, including 
32 relatives of lung 
cancer patients.  The 
mean score was 3.7, 
and the standard 
deviation was 2.6.  
With this SD, a 
reduction of the 
mean by 1.2 points 
could be detected 
with 83% power.  Caregiver burden is described by the research team’s previous work114 with 
mean objective burden subscale scores of near 22.0, with a pooled standard deviation of 
4.0.  With 80 subjects per group, a reduction by 1.8 points could be detected with 81% power. 
Hypotheses 1.2 address preparedness for caregiving and QOL. In our previous work, 
preparedness has been reported on a 1 to 5 scale with a mean of approximately 3.7 and SD of 
0.72.114 An increase in mean score from 3.7 to 4.1 could be detected with 93% power. Total 
QOL scores for 157 FCGs are reported by our previous work114, with a mean total score of 5.93 
and a standard deviation of 1.42. An increase in mean total QOL score of 0.7 could be detected 
with 87% power. Hypothesis 1.3 address changes in FCG cancer support services use. Here, we 
will classify each FCG as to whether they had an encounter with social work services and family 
resource center. A difference of 20 percentage points for social work referrals and 30 percentage 
points for family resource center would be detectable with 80 subjects per group.  
Specific Aim 2 addresses the effects of the MSM Intervention on patient outcomes, and 
Table 4 provides patient outcome effect size and power. Hypothesis 2.1 addresses patients’ 
psychological distress and QOL, and Hypothesis 2.2 addresses healthcare resource use. For each 
of these outcomes, 
the mean control 
group value, the root 
mean square (RMS) 
standard deviation, 
and the detectable 
improvements 
(Delta) in mean 
score was calculated 
for a two-sided 0.05 significance level test using 80 subjects per group.  For resource use, we 
will classify each patient as to whether they had in-home nursing care, urgent care/ER visits, or a 
readmission.  In preliminary data, 20 of 38 subjects had such an event, indicating that a 
difference of 22 percentage point would be detectable with 80 subjects per group. 
Specific Aim 3 addresses the effect of outcome mediators on FCG and patient outcomes 
(Table 5). Standard deviations 
(SD) were estimated from 
previous data. For activation, 
an improvement of the mean by 
8.0 points could be detected 
with 80% power. For self-
efficacy, an improvement of 
2.0 points could be detected 
Table 3. FCG Outcomes Effect Size and Power 
Outcome 
Measure 
         Effect 
SD 
Power 
H1.1 Psychological distress 
Distress thermometer 
3.7 v 2.5 
2.6 
83% 
H1.1 Caregiver burden 
Objective burden score 
22.0 v 20.2 
4.0 
81% 
H1.2 Caregiver preparedness 
Preparedness score 
3.7 v 4.1 
0.72 
93% 
H1.2 Caregiver QOL 
Total QOL score 
5.9 v 6.6 
1.42 
87% 
H1.3 Social work referrals 
FCG healthcare use 
20% v 40% 
NA 
80% 
H1.3 FCG center resource   use FCG healthcare use 
30% v 60% 
NA 
97% 
Table 5. Outcome Mediator Effect Size and Power 
Outcome 
Measure 
Detectable effect 
SD 
Power 
H3.1 Activation 
PAM and FCAT 
72.0 v 80.0 
18.0 
80% 
H3.1 Self-Efficacy 
Self-Efficacy Tool 
20.0 v 22.0 
22.0 
80% 
H3.1 Knowledge 
Knowledge Tool 
8.5 v 9.0 
1.0 
88% 
Table 4. Patient Outcomes Effect Size and Power 
Outcome 
Measure 
Detectable effect 
SD 
Power 
H2.1 Psychological distress 
Distress thermometer 
3.5 v 2.4 
2.4 
82% 
H2.1 QOL 
FACT-L 
93.7 v 101.3 
17.0 
80% 
H2.2 Resource use 
Any use (y/n) 
53% v 31% 
NA 
80% 

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with 80% power. For knowledge, a difference of 5.0 points can be detected with 88% for 80 
dyads per group. 
Sample Size and Power Calculation for Social Determinants of Health and Spiritual 
Well Being – Sample size calculation is based on linear multiple regression method using 
G*power (Version 3.1.9.4). This method tests the null 
hypothesis that the proportion of variance of the 
outcome explained by a set of predictors is zero (i.e., 
R2=0), while the alternative hypothesis is R2>0. 
Significance level is 0.05 and power is 0.8. 20% of 
attrition was considered in calculation.  
Two parameters need to be specified for sample 
size calculation74: effect size and number of predictors. 
The effect size is the ratio of proportion of variance 
explained by a set of predictors and error variance74. 
Since there is no published data for correlation between 
our outcomes and predictors in the target population 
(lung cancer), and due to the exploratory nature of the 
analyses, the effect sizes are estimates only. To cover 
potential effect sizes that our data may reveal, we employed different levels of effect size defined 
by Cohen75: small 0.15, medium 0.25, and large 0.35. The total number of predictors is 24 for 
FCG arm and 23 for patient arm. However, some predictors come from the same SDH domain, 
thus they would be highly correlated. To avoid multicollinearity in multiple regression model, 
some predictors may be removed from the final model. Therefore, we also used different number 
of predictors to calculate sample size (Table 2). Assuming the effect size 0.35 and 20% attrition, 
our target sample size will be 51 dyads (102 total participants) to detect deviation of R2 from 
zero with 0.05 significance level and 80% power.  
 
 
Data management is of key importance in this study.  Our institutional research 
informatics core will develop an electronic data entry, capture, and storage system that will 
perform tracking functions (accrual, enrollment, consenting, data collection, and intervention 
delivery). We will develop a query system to address data validity and integrity by making early 
identification of cases of recruitment irregularity, data collection inconsistency, data inaccuracy 
or incompleteness. Data will be audited for accuracy prior to scoring and analysis.   
 
Our primary data analysis will be according to intention-to-treat, i.e. all participants will 
be included in the analysis whether or not they received all prescribed intervention components. 
Participants who are lost to follow-up due to mortality will not be included.  Reasons for study 
dropout will be recorded. Participants with missing items will be compared with those having 
non-missing items to determine whether missing data are random or can be accounted for by 
other variables.  Broadly, our data may be missing at random (MAR) or missing not at random 
(MNAR). Generalized linear model with robust (sandwich) variance estimator model will be 
fitted to the data, with time, baseline, treatment arms, and interaction of time and treatment as 
explanatory variables. This approach provides valid standard errors with repeated measurement 
of individuals.  It also accommodates missing time points by using the model of time effects to 
reduce bias.  For MNAR, a pattern mixture model55 will be fitted to the data to correct for 
informative drop-out. In particular, three patterns will be defined: a pattern consisting of 
participants who died during the study period, a pattern of participants with relapse, and a pattern 
of participants who remained disease free.  Within each pattern, data will be modeled by the 
random effects model. To compare treatment arms, the effects of both arms will be respectively 
estimated using a weighted average across all patterns weighted by their sample proportions.  
Table 2. Sample size considering 20% attrition 
Number of 
predictors 
Effect size 
0.15 
0.25 
0.35 
9 
137 
87 
65 
14 
162 
104 
80 
19 
184 
119 
92 
24 
203 
132 
102 

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E.4. Preliminary Analysis - Initially, standard data descriptions, along with q-q plots and 
similar diagnostics will be used to check each outcome measure prior to analyses addressing 
hypotheses.  Transformations will be considered, if necessary, to improve symmetry, variance 
homogeneity, and distribution, and to accommodate floor and ceiling effects.  For several 
outcomes with high coefficient of variation, we anticipate using analysis on a logarithmic scale, 
potentially permitting presentation of geometric means and multiplicative effects. 
E.5. Statistical Methods by Study Aims  - Our general approach is to produce a confidence 
interval and corresponding hypothesis test for the effect of treatment (as intended) on each 
outcome, with the stratum used in randomization, and the baseline value of the outcome of 
interest included as covariables (i.e. analysis of covariance).  This approach reduces residual 
variance and improves power, and randomization removes potential bias due to baseline 
differences.  For the sake of robustness, secondary analyses will include a simple comparison 
without covariables, as well as a three-covariable model that includes a propensity score to 
address any residual imbalance in medical or socio-demographic variables.  This approach 
generally minimizes the missing data problem for the primary analysis. Multiplicity:  Planning 
is based on significance levels of 0.05, as each primary outcome is well-motivated a priori, and 
the merits of the intervention are expected to be seen in multiple outcomes.  Statistically 
significant change in a single outcome, as would be controlled by family-wise adjustment 
procedures, would not be enough to motivate continued pursuit of the intervention.  Two-sided 
significance levels are quoted. All of the hypotheses are also dividing hypotheses in the sense of 
Cox116 so both the a priori  direction, and the decision argument of Lehman117  justify two-sided 
tests. 
Specific Aim 1: Test the effects of the MSM Intervention on FCG outcomes and cancer support 
services use at discharge and 3-months post-discharge, comparing intervention and attention 
control groups. Hypothesis 1.1: The intervention group will experience lower psychological 
distress and caregiver burden. Hypothesis 1.2: The intervention group will experience higher 
caregiving preparedness and QOL. 
 
These two hypotheses will be tested in the same way. We will address the effect of the 
intervention on FCG psychological distress, burden, preparedness for caregiving, and QOL at 
months 1 and 3, adjusted for baseline response.  Scores for all outcome measures will initially be 
summarized graphically and numerically at baseline, month 1, and month 3, for each stratum, 
along with simple diagnostic plots. The need for transformation will be accessed.  A generalized 
linear mixed model will be fit to estimate the distribution of 1 month and 3 month score as a 
function of treatment, stratum, occasion (month 1 or 3) and baseline value.  The robust 
(sandwich) variance estimator will be used to accommodate the correlation of the two occasions, 
and the estimated treatment effect for the adjusted average of the 1 and 3 month outcomes will 
be estimated and tested, in order to limit multiplicity with respect to occasions, and to improve 
upon the designed power by combining information, effectively reducing standard deviations 
relative to those used for planning.  This is similar to the analysis of average outcome for the two 
post-treatment occasions, except that it accommodates missing outcome evaluations by 
attributing observations to the appropriate occasion (comparing like with like), and avoids 
overstating information.  Analysis of average outcome does provide a convenient robustness 
check. Each analysis will be a repeated measures ANCOVA statistical design, removing 
variances prior to examining mean squares for the group by occasion interactions, and covarying 
the baseline scores. The independent variable will be group (intervention vs. attention control). 
Hypothesis 1.3: The intervention group will have higher social work referrals and family 
resource center use.  
 
FCG cancer support services will be evaluated by recording social work referrals and family 
resource center use. Each subject will be classified as having an event or not.  There is no 
baseline value, but the data will be tabulated by surgery stratum, and tested for homogeneity 
(interaction) before estimating and testing the overall treatment effect. 
 

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Specific Aim 2: Test the effects of the MSM Intervention on patient outcomes and healthcare 
resource use at discharge and 3-months post-discharge, comparing intervention and attention 
control groups. 
Hypothesis 2.1: The intervention group will experience lower psychological distress and higher 
QOL. 
 
For this hypothesis, we will address patient psychological distress and QOL. Distress and 
QOL are each quantitative scales measured at both 1 month and 3 months. These will be 
analyzed by the same plan described for Specific Aim 1, hypothesis 1.1 and 1.2.  Each analysis 
will be a repeated measures ANCOVA statistical design, removing variances prior to examining 
mean squares for the group by occasion interactions, and covarying the baseline scores. The 
independent variable will be group (intervention vs. attention control). 
Hypothesis 2.2: The intervention group will have lower in-home nursing care, lower urgent 
care/ER visits, and lower hospital readmissions. 
 
Similar to Specific Aim 1, hypothesis 1.3, patient healthcare resource use will be evaluated 
by recording in-home nursing care, urgent caregcp/ER visits, and readmissions (COH and non-
COH encounters).  Each subject will be classified as having an event or not.  There is no baseline 
value, but the data will be tabulated by surgery stratum, and tested for homogeneity (interaction) 
before estimating and testing overall treatment effect. 
 
Specific Aim 3: Test the effects of the MSM Intervention on outcome mediators at discharge 
and 3-months post-discharge, comparing intervention and attention control groups. Hypothesis 
3.1: FCGs and patients in the intervention group will experience higher activation, self-efficacy, 
and knowledge. 
 
For this hypothesis, we will address outcome mediators, including FCG and patient 
activation, self-efficacy, and knowledge. These outcomes are each quantitative scales measured 
at both 1 month and 3 months. These will be analyzed by the same plan described for Specific 
Aim 1 & 2. Each analysis will be a repeated measures ANCOVA statistical design, removing 
variances prior to examining mean squares for the group by occasion interactions, and covarying 
the baseline scores. The independent variable will be group (intervention vs. attention control). 
In addition, we will use structured equation modeling (SEM) to evaluate whether a mediator 
accounts for all or part of the effect between treatment and outcome. We will focus on the 
following: 1) estimating how treatment affects mediators, 2) how mediators are associated with 
outcomes, and 3) estimating, at least roughly, the relative strengths of mediation by activation, 
self-efficacy, and knowledge, as well as direct effects on outcomes. Each FCG model will 
involve variables describing: intervention (treatment assignment), 3 mediational variables (1-
month activation, self-efficacy, knowledge), baseline values of 3 mediational variables, and 
primary outcomes (baseline values and 1-month). Intervention effect on patient outcomes is also 
proposed to be mediated by activation, self-efficacy, and knowledge. Each patient model will 
involve 11 observed variables: intervention (treatment assignment), 3 mediational variables (1-
month activation, self-efficacy, knowledge), baseline values of 3 mediational variables, and 
primary outcomes (baseline values and 1-month). 
 
Exploratory Aim 1: Explore moderators (age, sex, marital status, caregiver relationship to 
patient, caregiver employment status, co-morbidities) of FCG and patient outcomes and 
reciprocal relationships.  
In EA 1 we will examine moderators and reciprocal relationships of FCG and patient 
outcomes. Potential moderating variables to be examined include, for FCGs: age, sex, 
relationship to patient (spouse vs. others), employment, and co-morbidities. For patients, 
potential moderators include: age, sex, marital status, and co-morbidities. These will be explored 
for interactions with treatment in affecting outcomes (psychological distress, caregiver burden, 
preparedness, QOL at discharge and 3 months), and for interactions with treatment in affecting 
potential moderators. Reciprocal relationships between FCG and patient outcomes are proposed. 
FCG (psychological distress, caregiver burden, caregiving preparedness, QOL) and patient 
(psychological distress, QOL) data will be pooled and structured so that the family (FCG + 

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patient) is the unit of analysis. We will test the effects of FCG characteristics on patient 
outcomes through structural equation modeling (SEM). These models will allow for the 
simultaneous calculation of effects of FCG experiences on patient outcomes. The models will 
also account for the intercorrelation among caregiver-patient dyads for both predictors and 
outcomes. Model will be estimated using maximum likelihood estimation; this will allow 
patients to be included when FCG information is missing, and vice versa. This will be explored 
both by graphical display, and considering patient outcomes as time-varying predictors of 
caregiver outcomes. 
 
Exploratory Aim 2: Determine, through exit interviews, participant’s experience with the MSM 
intervention.   
We will use semi-structured interviews to examine dyadic experiences with the MSM 
Intervention. Qualitative data will be analyzed by the PIs using the conventional content analysis 
approach.118 This approach is used to describe a phenomenon where existing theory or research 
literature is limited. Data from the tape-recorded interviews will be transcribed and analyzed 
using HyperRESEARCH™ qualitative software. Transcripts will be imported allowing for the 
development of analytic categories, data coding, and review of coded data. All data will be read 
repeatedly to achieve immersion and obtain a sense of the whole. Then, data will be read word 
by word to derive codes. Codes will then be sorted into themes based on links and relationships. 
Separate investigators with experience in qualitative data analysis (Dr. Sun and Dr. Ferrell) will 
conduct a final validation review of the codes and themes to ensure consistency and clarity 
across all qualitative data. Data discordantly coded will be discussed for refinement and 
consensus purposes. 
 
Geriatric Assessment (GA) data for both FCGs and patients will be analyzed descriptively. 
We will use descriptive statistics (mean [SD], median [range], percentage [95% confidence 
interval]) to summarize GA scores and domains. We will also describe the patterns of changes in 
GA over time for both FCGs and patients. Changes will be calculated as post-surgery scores 
minus pre-surgery scores. Exploratory logistic regression models (univariate and multivariate) 
will be fitted to study the correlation between GA and FCG/patient outcomes. 
 
COVID-19 qualitative data will be analyzed using content analysis approaches as described 
under exploratory aim 2.  
 
Social determinants of health (SDH) data will be scored according to guidelines descriptively 
summarized. We will use multiple linear regression to test associations between baseline 
outcomes and SDH predictors. Baseline scores of outcomes activation, burden preparedness, 
self-efficacy, QOL and distress will be summarized with descriptive statistics. Distributions of 
SDH predictors will be summarized. For each outcome, we will use bivariate regression to assess 
the effect of one predictor at a time. Stepwise multivariate analysis will be performed to select all 
significant predictors (p<0.05). In addition, multicollinearity issues will be examined by 
calculating correlation matrix for all predictors and by checking variance inflation factors.  
Spiritual well-being data will be scored according to guidelines and descriptively 
summarized. Two subscale scores of spiritual well-being outcomes will be measured before 
(baseline) and after surgery (3-months post-discharge). Pre and post-surgery data will be 
compared to assess potential changes in each subscale scores for patient and FCG arms 
separately. We will use Generalized Estimation Equations (GEE) for comparison, adjusting for 
sociodemographic covariates. Similar to multiple regression analyses for research questions 1.1 
and 1.2, both bivariate and multivariate GEE models will be performed. Multicollinearity will 
also be examined. 
 

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Key Informant/Focus Group Data Analysis 
A codebook will be co-developed by the principal investigators of the parent R01 and the 
diversity supplement, along with study participants. Grounded Theory methods of emerging 
coding will be used and facilitated by QDA Miner. To ensure data validity, constant comparison 
method—each theme and interpretation will be compared with emerging findings from data 
analysis— will be used to confirm emerging themes. Member checking techniques—results will 
be returned to participants for accuracy and resonance of experiences— will be utilized to 
validate focus group results.  
 
14.0 Human Subject Issues 
14.1Institutional Review Board 
In accordance with City of Hope policies, an Institutional Review Board (IRB) that 
complies with the federal regulations at 45 CFR 46 and 21 CFR 50, 56 and State of California 
Health and Safety code, Title 17, must review and approve this protocol and the informed 
consent form prior to initiation of the study.  All institutional, NCI, Federal, and State of 
California regulations must be fulfilled. 
 
14.2Recruitment of Subjects 
Subjects will be recruited on the COH Duarte campus and South Pasadena community 
site and through the Division of Thoracic Surgery. 
 
14.3Advertisements 
No advertisements will be used for study accrual. 
 
14.4Study location and Performance Sites 
This study will be performed at COH. 
14.5Confidentiality 
This research will be conducted in compliance with federal and state of California 
requirements relating to protected health information (PHI).  The PHI that will be recorded 
includes name and medical record number. This information will be contained in a password 
protected database created by COH Research Informatics and monitored by the Study Personnel. 
Surveys administered to the subjects will not contain PHI information. 
 
14.6Financial Obligations and Compensation 
Subjects will not incur any financial obligations; they will be remunerated $50 each at 
completion of baseline and 3-month surveys ($100 per participant).  
 

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14.7Informed Consent Processes 
The Research Nurse and CRAs will contact eligible participants and explain the study 
purpose, answer questions, and ascertain interest in participation. The primary approach for 
informed consent will be during an in-person encounter. Obtaining a signature of the consent 
form by the patient/caregiver may also be completed by sending the consent form by mail or 
electronic mail, and returned to City of Hope, or electronically via other electronic applications 
(i.e. DocuSignTM). We will only use telephone verbal consents in situations where patients are 
not returning to COH prior to surgery date. If, during, the first phone call, participants are willing 
to consent for enrollment, the Research Nurse and CRAs will proceed with verbal consent. The 
Research Nurse and CRAs will document the provision of verbal consent via progress note as 
required by IRB policies.  
The Principal Investigator or IRB approved named designate will explain the nature, 
duration, purpose of the study, potential risks, alternatives and potential benefits, and all other 
information contained in the IRB approved Consent Forms and Information Sheets.  In addition, 
they will review the experimental subject’s bill of rights and the HIPAA research authorization 
form. Research subjects will be informed that they may withdraw from the study at any time and 
for any reason without prejudice, including as applicable, their current or future care or 
employment at COH or any relationship they have with COH.  Research subjects will be 
afforded sufficient time to consider whether or not to participate in the research. 
Should sufficient doubt be raised regarding the adequacy of comprehension, further 
clarifications will be made and the study information repeated until a satisfactory result is 
obtained.  Prospective research subjects who cannot adequately comprehend the fundamental 
aspects of the research study with a reasonable amount of discussion, education and proctoring 
will be ineligible for enrollment.  For those subjects who do comprehend the fundamental 
aspects of the study, verbal consent will be obtained and documented via progress note charted 
through electronic medical record system.   
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2. Siegel RL, Miller KD and Jemal A. Cancer statistics, 2016. CA: a cancer journal for 
clinicians. 2016;66:7-30. 
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cardiovascular and thoracic surgery. 2010;10:1015-21. 
4. Fujinami R, Sun V, Zachariah F, Uman G, Grant M and Ferrell B. Family caregivers' distress 
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6. Kim J, Sun V, Raz D, Williams AC, Fujinami R, Reckamp K, Koczywas M, Cristea M, 
Hurria A and Ferrell B. The impact of lung cancer surgery on quality of life trajectories in 
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7. National Cancer Institute. Intervening with Cancer Caregivers to Improve Patient Health 
Outcomes and Optimize Health Care Utilization. 2016. 
8. American College of Surgeons. Statement of Principles of Patient Education. 2006. 
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Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer 
Statistics Review, 1975-2012. 2015. 
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journal of medicine. 2013;369:448-57. 
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