Online Information and Support for Distance Caregivers
Phase: NA
Conditions: Advanced Cancer
Sponsor: Case Comprehensive Cancer Center

1 
 
Online Information and Support for Distance 
Caregivers 
 
 
NCT02666183 
 
12.13.21 
 
 
Study Protocol and Statistical Analysis Plan 
 
 

 
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DISTANCE CAREGIVER STUDY PROTOCOL 
     OBJECTIVES 
     The primary goal of this RCT is to compare outcomes (anxiety, distress, depression) for DCGs of patients 
with advanced cancer and/or patients receiving ongoing care from a medical oncologist who are randomly 
assigned to either the full intervention arm (Closer), the video-only intervention arm (Video-C Only), or the 
Web-Only group.  The goal is to determine which is most efficacious in improving outcomes over time for 
these caregivers.   
     RESEARCH SUBJECT SELECTION AND ELIGIBILITY 
     The sample will consist of patients with advanced cancer and/or patients receiving ongoing care from a 
medical oncologist and distance caregivers of these patients. Patients with any metastatic solid tumor will be 
recruited for participation in the study. Subject(s) selection will involve two phases:  first eligible patients must 
be identified and second, they must have eligible DCGs as well. 
     Inclusion and exclusion criteria include: 
     Patient inclusion criteria are:  1) a new diagnosis (within 3 months) of advanced cancer and/or patients 
receiving ongoing care from a medical oncologist (solid tumors) or a new recurrence of the primary cancer in an 
advanced stage; 2) receives ongoing care from a medical oncologist at the Seidman Cancer Center (SCC); 3) 
has English as the primary language; 4) has a life expectancy of >6 months; 5) provides consent for his/her own 
treatment and procedures; and 6) identifies a DCG involved in his/her care, support, or care planning. 
Exclusion:  The patient sample is limited to patients with advanced cancer and/or patients receiving ongoing 
care from a medical oncologist because the full intervention is tailored to meet the needs of DCGs of patients 
with advanced cancer and/or patients receiving ongoing care from a medical oncologist.   
     The second stage of selection and eligibility will involve DCGs.  
     DCG inclusion criteria are:  1) is an adult family member (at least 18 years old) of a patient with an 
advanced-stage cancer; 2) identifies himself/herself as a DCG for the patient; 3) lives >1 hour travel time away 
from the patient; 4) has English as his/her primary language; 5) is capable of providing informed consent; and 
6) will be able to access Internet (phone, computer, etc.).  The sole exclusion criterion is cognitive impairment. 
     For this study, DCGs will be defined as anyone who self-identifies as providing informal, unpaid care to a 
family member with advanced cancer and/or patients receiving ongoing care from a medical oncologist, who 
provides support to the patient, and who lives >1 hour away in travel time; a definition commonly used to 
define DCGs 1,2,4,77. 
 
RESEARCH SUBJECT ENTRY 
     Subject recruitment:  Potential patient subjects will be obtained from a list of patients who have 
appointments to be seen in the outpatient clinic at the Seidman Comprehensive Cancer Center (main campus).  
Research Assistants (RAs) will obtain a list of patients who meet eligibility criteria each week from the 
outpatient clinic staff.  RAs will review subject charts to confirm eligibility of these subjects prior to their 
outpatient appointment.   
   
Informed Consent for patient and DCG: At their outpatient clinic visit, all subjects who meet eligibility 
criteria will be approached by the RA and asked if they have a DCG.  For those who have a DCG, the RA will 
describe the study and ask if the RA if he/she (RA) can contact the DCG to talk about the study and to invite 
participation.  The RA will then obtain contact information from the DCG and contact them, describe the study, 
and ask for consent.  Only after the DCG consents, will the RA obtain written consent from the patient. The RA 
will contact the DCG by telephone within a week of meeting with the patient.  If the patient does not give the 
RA permission to contact the DCG or if the DCG does not consent to participate then neither the patient nor the 
DCG will be enrolled in the study.  In our pilot, 90% of patients agreed to let the RA contact the DCG.  Using 

 
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this procedure in our pilot study, we were able to obtain consent and enrollment data from the patient and the 
DCG within 7 days of one another. 
     Subject randomization:  Once consent has been obtained, the DCG subject will be randomly assigned by 
the Project Director to one of three arms of the study. Randomized to one of the three study groups will involve 
using the minimization stratified randomization technique. Minimization is designed to balance pre-identified 
stratifying covariates across treatment assignments more effectively than simple randomization79. Stratification 
variables will be DCG age, gender and patient cancer stage.  We will use the free online program MinimPy97. 
     Allocation concealment:  For DCGs assigned to the Closer or Video-C Only groups, the Project Director will 
email the link to download the free WebEx application that will be needed for all videoconference sessions.  For 
subjects in the Web-Only group, the Project Director will email them to download an application that will allow 
the DCG to click on an icon and be directly connected to the DCG website used for this group.  This procedure 
will blind RAs to group assignment. 
 
STUDY DESIGN AND METHODS 
     Design/Study Type  
    This proposed three group RCT will examine the effects of videoconference technology (information) during 
patient-oncologist office visits and the added effects of from RN coaching sessions (information + emotional 
support) using videoconference technology.  The study will use an experimental design with random 
assignment of DCGs to groups.  
     Selection of Instruments 
     Study measures will be obtained at enrollment and 4 months later (Table 1).    
 
Description of Intervention 
     Closer Intervention.  The full intervention (Closer) is a tested intervention that uses videoconferencing 
technology (WebEx) for delivery and delivers the highest dose of the intervention.  This arm of the intervention 
will deliver personalized information (aimed at enhancing self-efficacy) and emotional support via RN or SW 
Table 1.  Study Tools and Measures 
Variable 
Measure 
 
    Time of measure 
     Enroll  4M      
Reliability  
Outcome Variables 
 
 
 
Distance Caregiver  
PROMISR* (SFv1.0-ED-Anxiety-SF4a) 
     X           X             r=.96 
Distance Caregiver  
NCCN Distress Thermometer 
     X           X             r=.80 test-retest 
Distance Caregiver  
PROMISR (SFv1.0-ED-Depression-SF4a)      X           X             r=.83 
Distance Caregiver Health Status 
MOS-SF12** (GSRH-Item 1) 
     X           X             r=.79 test-retest 
Patient Anxiety 
PROMISR (SFv1.0-ED-Anxiety-SF4a) 
     X           X      
r=.96 
Patient Distress 
NCCN Distress Thermometer 
     X           X      
r=.80 test-retest 
Patient Depression 
PROMISR (SFv1.0-ED-Depression-SF4a)      X           X             r=.83 
Appraisal Variable 
 
 
 
Caregiver Burden 
Zarit Burden Interview-12 
     X           X             α=.88-.99 
Covariates 
 
    Enroll    4M      
 
Distance Caregiver demographics (age, race, gender) 
Enrollment form 
     X           
NA 
Mechanisms of Intervention Variables 
 
 
 
Self-Efficacy 
Caregiving Self-Efficacy Scale 
     X           X         
α=.82-.91 
Emotional Support 
PROMISR(Item Bankv2.0-Emotional support)      X           X      
α=.90-.99 
Descriptive Variables 
 
    Enroll     4M    
 
Patient: Age, gender. 
Distance Caregiver: Socioeconomic & marital status, 
work productivity, computer competence/literacy.   
Enrollment form 
 
Enrollment form 
    X 
   
    X 
NA 
 
 
Recovery Experience Questionnaire: Psychological 
Detachment Subscale 
Enrollment form 
    X  
 
*PROMISR: Patient Reported Outcomes Measurement Information System; **MOS-SF:  Medical Outcomes Study Short-Form 12; 
GSRH:  General self-rated health (Item 1). 

 
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coaching as well as the opportunity to talk with the oncologist and patient in “real time” during a minimum of four 
patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one 
oncologist-patient meeting/month, we will use the videoconference technology to allow the DCG to join as many 
of the oncologist-patient office visits as desired.  
     After study enrollment, DCGs will be contacted by the interventionist who will conduct baseline assessments.  
Afterwards, each DCG will schedule a videoconference coaching session with the interventionist (each lasting 20-
30 minutes)46,51 approximately once/month depending upon caregiver’s need and availability.   
      
Table 2:  Key Components of Closer Intervention 
Videoconference 
Coaching & Office 
Visit Sessions 
Information to Enhance Self-Efficacy 
as a DCG 
 
       Emotional Support 
 
Session 1 
[At study 
enrollment] 
• Interventionist performs baseline assessment of DCG 
using PAL-23-25 Guidelines from NCCN62 
(understanding of course of disease, amount of information 
desired, values with respect to QoL).  
• Interventionist performs baseline assessment 
of caregiver distress, practical, family, 
emotional concerns (NCCN Assessment: 
DIS-A) & caregiver spirituality (Facit-Sp 
Assessment) 
Sessions 2 – 4 
[Focus & amount of 
services provided 
over time is 
determined by  
assessment and 
caregiver need and 
will vary over time] 
 
 
 
 
• Based upon assessment results: 
1. Develop a plan of care for DCG to provide 
tailored information and assistance that is 
needed.  
2. Provide information (after HIPAA release 
provided by patient) regarding test results, 
changes in treatment plan, and care transition 
information. 
3. Provide referrals for information or other 
community services as needed.  
4. Assist the DCG with coordinating services or 
care for patient among multiple providers (if 
needed).  
5. Discussions related to advance care 
planning.(See NCCN Guide: PAL-27)  
6. Provide any information needed in terms of what 
to expect along the disease trajectory, additional 
information as patient’s disease progresses, and 
resources that may be needed in the future.  
Assist DCG in obtaining information about 
resources. 
7. Demonstrate online resources such as NCCN          
(www.nccn.org/patients/resources/life_with_canc
er/distress.aspx) 
8. Provide information & discuss self-care 
strategies that may be of help to DCG (e.g. diet, 
exercise, stress reduction). (NCCN Guide: PAL-
25) 
•  Based upon assessment results: 
1. Make referrals for spiritual and/or 
psychological counseling if indicated. 
(See  NCCN Guide: DIS 16, 20-28)  
If no referrals available locally for 
DCG, arrange videoconference 
meetings with SCC social workers, 
spiritual counselors, chaplin etc.  
2. Provide emotional support to DCG as 
needed. 
3. Provide anticipatory grief support and 
end-of-life education as needed. 
(NCCN: DIS-22). 
4. Identify resources for ongoing 
emotional and social support (online 
groups, local support groups, ways to 
utilize existing support systems). (e.g. 
www.nccn.org/) 
5. Conduct ongoing assessment in key 
areas identified at baseline as areas of 
concern to monitor.  Provide 
additional feedback, support, or 
guidance as needed for DCG to obtain 
various types of support as needed. 
(See NCCN Guide: PAL-25) 
Videoconference 
Office Visit 
Meetings with 
Oncologist, 
Patient, DCG 
1.  Interventionist will be linked via videoconference to 
the oncologist-patient-DCG meetings and will provide 
the DCG feedback at subsequent coaching sessions 
regarding ways to enhance the caregiver’s role as 
1.  Interventionist will be able to provide 
emotional support to DCG as needed as it 
relates to discussions that occurred in the 
oncologist-patient-DCG videoconference 
meetings.   

 
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    Video-C Only.  This arm will involve the delivery of information solely via the use of videoconference 
technology during the patient-oncologist-DCG visit.  As with the Closer intervention, the DCG will be able to 
participate in the patient-oncologist visit in “real time” during a minimum of four office visits over the 4-month 
study period (total dose ~5 hours).  The procedure for these meetings will be the same as outlined for Closer 
(above) but will not involve having the interventionist involved. 
     Web-Only.   This group will be provided access to a website that will provide the following major links:  a) 
Caregiving Resources (links to “National Family Caregiver Association”, etc), b) Resources for DCGs (links to 
“Caregiving from a Distance”, etc), c) Cancer Information (links to National Cancer Institute, etc.).  DCGs will be 
told that we will track usage of the website in order to assess which areas of the website are used most frequently. 
Any questions or concerns regarding use of the website can be sent online to the study’s technical site, and the 
support staff will respond within 24 hours.   
 
Data Collection 
     As seen in Table 1, data (patient and DCG) will be collected by the RA at student enrollment (after consent is 
obtained from patient and DCG) and 4 months later (after the end of the intervention period).     
     Description of Study Process 
     At study enrollment, patient demographic information will be obtained through a brief 5 minute interview 
conducted by the RA during an outpatient clinic visit. Instruments for patients will be interviewer-administered 
(10-20 minutes maximum).  Interviews with patients will be conducted in person when possible at the time of the 
patient oncology visit, and the order of tool administration will be randomized.  If this is not feasible, patients will 
be interviewed by phone.  Instruments for DCGs will be conducted by the RAs via telephone at a time convenient 
for the DCGs. Interviews will be scheduled to take place at the time of enrollment, and then 4 after enrollment. 
The interviews will include administration of study tools (Table 1) in a random order.  The RAs (blind to study 
arm assignment) will use established interview protocols from our prior research that have shown a minimum of 
subject burden. From prior work, these interviews are estimated to last 10-20 minutes46.   
     Adverse Reactions and Their Management 
     As they occur, all unanticipated events and adverse events will immediately be reported to the principal 
investigator who will report them to the IRB according to the IRB protocol for both serious and non-serious 
adverse event and unanticipated problem reporting.  These will be summarized in the twice annual reports 
Annual progress reports to the IRB and NINR/NIH will include a summary of the Data and Safety Monitoring 
Committee’s activities and findings as well as any adverse events regarding human subjects.  Program officials 
at NINR will be informed within 3 business days of unanticipated problems (e.g. data breach) or unexpected 
serious adverse events that may be related to the study protocol or IRB-approved revisions to the study protocol 
that indicate a change in risk for participants. 
   Patients will be interviewed in person during a clinic visit at the Seidman Cancer Center (SCC) at study 
enrollment and then 4 months after study enrollment.  During these interviews, data will be obtained related to 
patient anxiety (PROMIS Anxiety-SF4a), distress (NCCN Distress Thermometer), and Patient Depression 
(PROMIS Depression-SF4a).  If, during the interviews, the research assistant (RA) obtains data from the patient 
that indicates that their NCCN Distress Thermometer score is >5, the RA will refer the patient to the social 
worker at the SCC for further evaluation and referral as needed.  The SCC has this procedure as part of their 
standard of practice and our research team will utilize this existing pattern of referral.  For patients with anxiety 
scores >6083 or depression scores > 58.698 the RA (or a member of the research team) will contact the patient’s 
(minimum 
1/month x 4 
months) 
patient advocate and ways to communicate with the 
healthcare team should these issues be of concern. 
2. Interventionist will follow up in subsequent coaching 
sessions with DCG on clarifying any information 
discussed at the meetings, providing more information 
as relevant to issues discussed with patient and 
oncologist at the prior office visit meeting 
2. Topics discussed at the videoconference 
meetings that have raised emotional 
issues with the DCG or that the 
Interventionist feels might warrant 
follow-up discussion (e.g. EOL issues) 
can be further explored at subsequent 
coaching sessions. 

 
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primary oncologist and will collaborate to determine the appropriate referral (SCC psychiatrist or other mental 
health professional) on the day of the interview.   
   Distance Caregivers (DCGs) will also be interviewed at study enrollment and then 4 months after study 
enrollment.  These interviews will take place on the phone with the caregivers being at varying distances from 
the SCC.  If, during the interview, their scores on the anxiety, depression or distress measures (same as for 
patient) exceed the thresholds established (same as for patient), the RA will reflect to the DCG that their 
score(s) indicate distress (or anxiety, depression) and the RA will encourage them to contact their primary care 
physician or a local mental health professional.  We will tell the DCG that if it would be helpful, we could try to 
identify some contact/facilities in their area and if the DCG is interested, the RA will contact the Project 
Director who will identify some appropriate contacts for the DCG.  The RA will call the DCG and share that 
information within 48 hours of the interview.   If the DCG depression score falls within the “severe” range 
(>70.3)98 the RA will follow the protocol outlined but will make a follow-up call within 24 hours. 
     Serious adverse events that have any possible relation to the study be reported immediately to the IRB. Less 
significant events and events that have no relation to the study procedures will also be reported to the IRB in a 
timely fashion. 
     Anticipated Reactions 
     A risk involved in the study is that patients and/or caregivers might become tired during the interview or 
they may find talking about feelings to be upsetting.  The interviews will be scheduled at the convenience of the 
patients and/or caregivers and they may stop the interviews at any time if they become tired or simply wish to 
stop talking.   They can elect to not answer any question they find upsetting and can choose to stop participating 
completely in the study at any time. Participation or non –participation will have no effect on the type or quality 
of care that the patient receives.  A research assistant who is not employed by the hospital will obtain all 
research data.   
     Reaction Management 
      This study involves an intervention—thus a Data and Safety Monitoring Committee (DSMC) will be formed 
for this study.  This committee will be comprised of members outside the study team and the Chair of the 
committee will be responsible for submitting reports to NINR within 2 weeks of the meeting.  The committee 
who are outside the study team will review data on the study as provided by the PI.  Twice annually throughout 
the project, this committee will review data on this study regarding: (1) study safety including auditing selected 
cases for compliance with IRB requirements, (2) conformance with informed consent requirements, verification 
of source documents, and investigator compliance, (3) minimizing research-associated risk, and (4) protecting 
the confidentiality of participant data.  In addition, it will review all causes of mortality and issues with 
participation.  The rate of recruitment refusal (percent and reasons) and subject attrition (percent and reasons) 
will be tracked and reported at these reviews.  Differential attrition form all study groups will be monitored.  If 
concerns or problems are identified by the DSMC, they will be reported to the IRB and NINR/NIH via email by 
the Chair of the DSMC within 3 business days after they are identified.   
      
STATISTICAL ANALYSIS 
     This study is an evaluation of a randomized three group trial.  The major aim is listed, followed by hypotheses 
and analyses.  
     Aim 1: Compare the direct effects of Closer, Video-C Only, and Web-Only on DCG outcomes (anxiety, 
distress, depression) over time, controlling for DCG demographic variables.   
     H1: DCGs in the Closer arm will show significantly greater reductions, over time, in DCG outcomes (anxiety, 
distress, and depression) and significantly greater improvement in health status than subjects in the Video-C Only 
and Web-Only groups.  
     Primary endpoints 
     The primary purpose of the study is to examine the effectiveness of two videoconference-based interventions 
(Closer, Video-C Only) when compared to a Web-Only group upon psychological outcomes for DCGs of 
patients with advanced cancer.   

 
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     Power Analysis for Sample Size 
     Using a repeated measures analysis with within-between interaction, 3 repeated measures, Type I error of 
0.05, and a correlation among repeated measures of 0.5, 104 subjects in each of the three arms would have a 
power of .95 to detect a difference in the rate of improvement between the three groups, assuming an effect size 
of .15 or greater78.  
     Stratification factors and intervention allocation plan for randomized studies 
     Randomized to one of the three study groups will involve using the minimization stratified randomization 
technique. Minimization is designed to balance pre-identified stratifying covariates across treatment assignments 
more effectively than simple randomization79. Stratification variables will be DCG age, gender and patient cancer 
stage.  We will use the free online program MinimPy97. 
     Allocation concealment:  For DCGs assigned to the Closer or Video-C Only groups, the Project Director will 
email the link to download the free WebEx application that will be needed for all videoconference sessions.  For 
subjects in the Web-Only group, the Project Director will email them to download an application that will allow 
the DCG to click on an icon and be directly connected to the DCG website used for this group.  This procedure 
will blind RAs to group assignment. 
     Analysis plan 
     Preliminary steps will include examining the frequencies of items to identify the range of variability of each 
item (e.g., having a range of responses and not having any one category account for >90% of all possible 
category responses), determine coding inaccuracies, check for outliers, and missing data, and to verify sample 
size, and normality of data.  Descriptive statistics will include examining means, standard deviations, and 
testing for normality using skewness and kurtosis.  
     Prior to testing the Aims, additional correlational analyses will be run as the first step to identifying potential 
relationships among the components identified in the study model. These correlations will be used to prescreen 
potential violations of the assumptions of correlation.  Additionally, scatter plots between the two variables can 
help identify influential cases, as well as patterns of nonlinearity and non-constant error variance that may 
reduce a Pearson’s r. To remedy the potential violation of the assumptions, influential cases can be removed 
and models retested to determine Pearson’s r improvement. Data transformations can be used to remedy issues 
concerning non-linearity, non-constant error variance, and non-normal error variance.  These prescreening 
techniques will help prevent potential problems that may occur when these relationships are tested in our main 
analyses.  
     Analyses.  Two types of analyses are planned.  The first will be a preliminary analysis using exploratory 
techniques to examine univariate characteristics and bivariate relationships among covariates and between 
covariates with outcomes. These exploratory techniques will be based upon proportions, medians and/or means. 
The change in each of the DCG outcomes (anxiety, distress, depression) with time over the 4-month study 
period will be examined by a repeated measures multivariate regression analysis with covariates entered into the 
model.  A time variable will be created to represent the time of measurement (enrollment, 4 months); and the 
intervention variable will be expressed using the indicator variables (representing Closer, Video-C Only, Web-
Only). The regression coefficient term representing the interaction between time and intervention will indicate 
whether there are differences in changes over time between the two intervention groups and the web-only group 
within the context of each of the outcome. 
     A preliminary step of the multivariate analysis will be to characterize and estimate the relationship of each 
outcome as measured in Aim1 with the intervention indicator variable, controlling for DCG demographics (age, 
race, gender). The intervention indicator variable will be the focal independent variable.  For continuous 
variables that do not have a linear relationship with a specific outcome, appropriate transformations or 
categorization will be considered.  For nominal and ordinal variables, the number and type of categories will be 
considered to obtain the optimum relationship, if any, with the outcome.  After this initial step, any variable 
found to have a significance level less than 0.30 will be retained for further consideration in the model building 
process.  A backward elimination process will be used to assess the relationship between each outcome and 
available covariates. Goodness of fit tests will be examined to determine the soundness of the models and the 

 
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relative importance of the various factors present on each outcome.  Estimates of regression coefficients and 
their variance-covariance matrix will serve as the basis for testing hypotheses.  Once a preliminary model 
containing significant main factors is obtained, interaction terms between the main factors and the intervention 
variable will be considered.  For the major aim, the outcome variables are: DCG anxiety, distress, and 
depression. In addition, we will be able to classify differences in outcomes by groups using criteria of 
minimally important differences for PROMIS scales for patient with advanced stage cancer93.  This will 
facilitate our interpretation—not only of statistically significant findings but of clinically significant findings as 
well.   
    Handling missing data in the analysis. 
    Missing data is a problematic issue when dealing with longitudinal data sets.  Some individuals may quit the 
study or not participate at a specific data collection point.  AMOS will allow for analysis of incomplete data 
using Full Information Maximum Likelihood (FIML) estimation.  Issues of nonrandom missing data are of 
particular interest in longitudinal data because dropout rates are not a random process; to the extent this is 
predicted by variables included in the data analysis, FIML will provide unbiased parametric estimates. 
 
 

 
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