Palliative Care for Elderly Outpatients
Phase: NA
Conditions: Cancer Terminal
Sponsor: University of Florida

1                              Palliative Care for the Elderly Outpatient, May 12, 2020 
 
RESEARCH PROTOCOL 
 
Investigators: 
 
Diana J. Wilkie, PhD, RN – Principal Investigator, UF College of Nursing  
Yingwei Yao, PhD – Co-Investigator, UF College of Nursing 
Sheri Kittelson, MD – Site Director, UF College of Medicine 
Linda Emanuel, MD – MPI, Northwestern University 
Joshua Hauser, MD – Site Director, Northwestern University 
George Fitchett, PhD, DMin – MPI, Rush University 
Sean O’Mahony, MD – Site Director, Rush University 
Tammie Quest, MD – Site Director, Emory University 
Michael Rabow, MD - Site Director, UCSF 
Marvin Delgado, MD - Site Director, MD Anderson 
George Handzo, MDiv – Co-Investigator, Health Care Chaplaincy of New York 
 
Background and Purpose:  
 
Our long-term goal is to improve spiritual care outcomes for elderly patients with cancer. We will 
use a spiritual intervention, Dignity Therapy (DT), to help these patients maintain pride, find 
spiritual comfort, enhance continuity of self, and ultimately make meaning of their life 
threatening illness. However, to date, DT has not been viewed as a spiritual intervention or 
studied with chaplains as the interventionist. Our thesis is that DT will systematize spiritual care 
processes and improve patient outcomes (spiritual and cancer prognosis awareness). The 
spiritual outcomes are important because people with advanced illness report that being at 
peace with God is as important as freedom from pain.1 Spiritual concerns are issues for 86% of 
patients with advanced cancer.2  Unfortunately, little research guides interventions for spiritual 
care. We will address this gap by testing efficacy of DT in a rigorous, multi-site, randomized 
controlled trial (RCT).3  
 
Previous studies of DT demonstrated clear feasibility and inconsistent efficacy of DT with 
virtually no evidence of its mechanism of action. Specifically, the 12 studies of DT (8 
uncontrolled feasibility; 4 mostly small sample efficacy RCTs) show DT to be an important 
intervention when delivered by nurses and mental health professionals, but effects on patients’ 
distressing physical or emotional symptoms of life-threatening illness have been inconsistent. 
Taking a spiritual perspective for reanalysis of data from the one large RCT,5 we found that 
compared to usual care, patients who received DT reported significantly higher dignity impact 
ratings, which is consistent with the DT focus on meaning making, preparation for death, and 
life-completion tasks. Evidence from our pilot study also suggests that awareness of cancer 
prognosis outcomes and will-to-live is facilitated by DT.4 One possible explanation of the lack of 
DT effect on physical symptoms could be that symptoms only moderate the DT effect, so 
conceptualizing symptoms as the relevant outcome is mismatched to the operative DT 
elements. It is also possible that spiritual distress could moderate the DT effect on patients’ 
sense of meaning and purpose,5 which is an important part of dignity impact. Two disciplines 
typically part of the palliative care team are known for their focus on spiritual concerns—nurses 
and chaplains. A nurse-led or chaplain-led DT study of patients receiving outpatient palliative 
care is needed to determine the efficacy of DT on key spiritual-related patient outcomes (dignity 
impact, existential tasks, cancer prognosis awareness) and explore possible moderators 
(physical symptoms and spiritual distress) of DT’s effects on patient outcomes.  
 

2                              Palliative Care for the Elderly Outpatient, May 12, 2020 
 
We propose a pre/posttest, RCT with a 4-step (12 months per step), stepped-wedge design3 to 
compare effects of usual outpatient palliative care (usual care) and usual care along with either 
nurse-led or chaplain-led DT on patient outcomes (dignity impact, existential tasks [preparation 
for death, life completion], cancer prognosis awareness [peaceful awareness, treatment 
preferences]). We will assign 6 outpatient palliative care sites to usual care during the first-step, 
and randomly assign two sites per step to begin and continue DT led by either a nurse or a 
chaplain during each of the next 3 steps. During the usual care steps, 280 patients will complete 
pretest measures (patient outcomes, covariates [physical symptoms, spiritual distress], and 
satisfaction with palliative spiritual care services), receive usual palliative care, and complete 
posttest measures (patient outcomes, covariates, satisfaction). During the experimental steps 
as part of routine palliative care service delivery, 280 patients will complete pretest measures, 
receive nurse-led or chaplain-led DT, and complete posttest measures. Using mixed level 
analysis with site, provider (nurse, chaplain) and time (step) included in the model, we will 
compare the usual care and each of the DT groups for effects on dignity impact, existential 
tasks, and cancer prognosis awareness and explore the moderating effects of physical 
symptoms and spiritual distress. We will also determine the effect of usual care and DT on the 
patient’s satisfaction with palliative spiritual care services and the report of the patient’s unmet 
spiritual needs.  
 
Specific Aims: 
      
In a diverse sample of 560 elderly cancer patients, the specific aims are to: 
 
 
Aim 1. Compare usual care and usual care with nurse-led or chaplain-led DT groups for effects 
on:   
 
a) patient outcomes (dignity impact, existential tasks [preparation for death, life 
completion], cancer prognosis [peaceful awareness, treatment preferences]). We hypothesize 
that, controlling for pretest scores, each of the DT groups will have higher scores on the dignity 
impact (1° outcome) and existential tasks (2° outcome) measures than the usual care group. 
Also patients in each of the DT groups will report better peaceful awareness and treatment 
preferences more consistent with their cancer prognosis (2° outcomes) than the usual care 
group; and  
 
b) processes of delivering palliative spiritual care services (satisfaction and unmet 
spiritual needs; 2° outcomes). We hypothesize that each of the DT groups will show increased 
patient satisfaction with spiritual care services and fewer unmet spiritual needs compared to the 
usual care group. 
 
Aim 2. Explore the influence of physical symptoms and spiritual distress on the dignity impact 
and existential tasks effects of usual palliative care and nurse-led or chaplain-led DT. We 
hypothesize that physical symptoms and spiritual distress will significantly affect intervention 
effects. This rigorous trial of DT will constitute a landmark step in gero-oncology palliative care 
and spiritual health services research. 
 
 
 

3                              Palliative Care for the Elderly Outpatient, May 12, 2020 
 
Study design: 
 
We propose a 6-site, pre/posttest, randomized, controlled 4-step, stepped-wedge design to 
compare the effects of usual outpatient 
palliative care and usual outpatient 
palliative care along with nurse-led or 
chaplain-led DT on patient outcomes 
and palliative care processes. We will 
assign the 6 sites to usual care during 
the first-step period (10 months), and 
randomly assign 2 sites per step to 
begin and continue DT during each of 
the next 3 steps (10 months each). 
Figure 1 shows the stepped-wedge 
study design with projected numbers of 
completed patients needed per site, step period, and group (usual care, DT led by either a 
nurse or a chaplain). Dr. Yao, a highly qualified statistician will conduct the randomization of site 
to steps 2-4. Each step will be 10 months long, with DT training during a 1-week period between 
steps. For each site/step, a quota of 50% of the participants will report low or high distress on 
the Personal Dignity Inventory to assure we recruit a sample with a range of problems 
threatening their dignity. Each patient will participate for 4-6 weeks. Over the 10 months at each 
step, we expect 23-24 patients to participate at each site (93-94 total patients per site). 
 
Subject identification, recruitment and consent: 
 
We will recruit the study sample from the population served by the six hospitals participating in 
this application. The sites represent the South Eastern (Emory University, UF Health 
Gainesville), North Midwest (Northwestern University, Rush University), South Midwest (MD. 
Anderson), and Western (University of California at San Francisco) areas of the U.S. The 
participants will be elders who are diagnosed with cancer and are receiving outpatient palliative 
care services at the participating sites. At UF Health, we will recruit the sample from the existing 
outpatient oncology palliative care services and those under development within the UF Cancer 
Center.  
 
The consent process will be completed in person and in a private area at the outpatient 
palliative care services of the 6 sites, or at another outpatient palliative care site or other private 
location chosen by the potential subject to go over the details of the study and informed 
consent. The consent process may also be conducted by phone with the signed consent form 
returned by mail in a preaddressed, stamped envelope. 
 
 
 
Figure 1. Stepped-wedge design    N per step per site         Total N 
Site 6 
23 
23 
23 
24 
93 
Site 5 
23 
23 
23 
24 
93 
Site 4 
24 
23 
23 
24 
94 
Site 3 
24 
23 
23 
24 
94 
Site 2 
24 
23 
23 
23 
93 
Site 1 
24 
23 
23 
23 
93 
Step 
1 
2 
3 
4 
 
Patients/ 
Step Period 
142 
138 
138 
142 
560 
Usual Care 
  
  
  
  
280 
Nurse-Led DT 
  
  
  
  
140 
Chaplain-Led DT 
  
  
  
  
140 
Step Period Duration (mo) 
10 
10 
10 
10 
40 

4                              Palliative Care for the Elderly Outpatient, May 12, 2020 
 
Procedures:  
 
The study will be conducted in the outpatient clinic in spaces available for research or virtually 
via a HIPAA-compliant video-conferencing platform. The investigators will attend patient care 
planning meetings and introduce the study to the palliative care team members. Any member of 
the palliative care team will refer patients to the RA on the day the patient is seen in the 
palliative care clinic or via a HIPAA-compliant video-
conferencing platform. 
 
Figure 2 shows the general flow of patients through the 
outpatient palliative care clinics and study procedures for 
this study of nurse-led or chaplain-led DT over 4-6 weeks. 
Prior to participant recruitment, the research assistants 
(RA) will be trained in all study procedures. Prior to 
stepping up to the DT steps of the study, the nurse and 
chaplains at the sites scheduled to begin the DT will be 
trained in the DT.                                                                                                                                                     
 
Study Procedures:  
 
I. 
The RA will recruit the referred and potentially 
eligible patients for this study, provide and obtain 
informed consent, determine final eligibility, and 
schedule time before the next clinic visit or at a 
time convenient to the patient for the patient to 
complete the pretest tools via an audio-recorded 
interview documented on REDCap forms and stored 
on REDCap for quality control purposes.  
 
II. 
Then the RA will inform the nurse/chaplain that the patient is available for care (usual 
care or DT, depending on the study step and site). The nurse/chaplain will provide the 
designated care on the same day as the pretest data collection, as specified in the 
following section: 
   
a. Usual care. Palliative care nurses usually see patients each clinic visit to assess vital 
signs, function, symptoms, and to provide patient and family education. They 
document findings and interventions in the electronic health record (EHR). Whereas 
usual care for palliative care chaplaincy in the outpatient setting varies by site, 
chaplaincy care for usual care patients in this study will follow the usual practice for 
inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and 
assess their spiritual and religious needs. This assessment is then memorialized in a 
spiritual treatment plan documented in the EHR.  
 
b. Dignity Therapy. The DT intervention is detailed in Chochinov’s manualized guide; 
he serves as our co-investigator and will conduct trainings for the team. The basic 
questions of the DT interview appear in Table 2. The nurse-led or chaplain-led DT 
intervention involves three sessions, each of which follows a set process (Fig 2). The 
standardize approach to the delivery of the intervention facilitates a personal process 
of reflection and recognition that allows the patient to make meaning of their 
experience. 
 
 

5                              Palliative Care for the Elderly Outpatient, May 12, 2020 
 
 
Table 1. Examples of the Dignity Therapy Question Protocol 
1. Tell me about your life history; particularly the parts that you either remember most or think 
are the most important? When did you feel most alive? 
2. Are there specific things that you would want your family to know about you, and are there 
particular things you would want them to remember? 
3. What are the most important roles you have played in life (family roles, vocational roles, 
community service roles, etc.)? Why were they so important to you, and what do you think 
you accomplished in those roles? 
4. What are your most important accomplishments, and what do you feel most proud of? 
5. What are your hopes and dreams for your loved ones? 
6. What have you learned about life that you would want to pass along to others?  
7. What advice or words of guidance would you wish to pass along to your [son, daughter, 
husband, wife, parents, other(s)]? 
8. Are there particular things that you feel still need to be said to your loved ones, or things 
that you would want to take the time to say once again? 
9. Are there words or perhaps even instructions you would like to offer your family, in order to 
provide help to prepare them for the future? 
10. In creating this permanent record, are their other things that you would like included? 
 
When the nurse/chaplain session(s) are completed, the nurse/chaplain will inform the 
RA that he/she has completed all nurse/chaplain session(s). The interview will be 
conducted either in person in the clinic or at a time and place convenient to the patient 
(e.g., home, community setting), or via a HIPAA-compliant video-conferencing platform.  
 
III. 
Either in-person if the patient has a clinic visit, by telephone contact or via a HIPAA-
compliant video-conferencing platform, the RA will schedule the follow-up appointment 
at a time and place convenient to the patient (e.g., clinic, home, community setting), and 
complete the audio-recorded posttest measures within 5-10 days. Upon completion of 
posttest measures, the RA will provide $50 (cash or card) to the patient for time and 
travel expenses to complete study measures. 
 
Sample size:  
 
We will recruit 1500 adults with cancer diagnoses who are receiving care from the outpatient 
palliative care services of the six hospitals. From this sample, 560 patients will complete the 
study and provide data for analysis, 280 for the DT groups (140 per each of the two DT groups) 
and the 280 for the control groups. From UF Health, we expect to recruit 94 total patients, 23-24 
per year with complete data. We will consent approximately 1,500 (250 total patients per site) 
for screening over the 4.5 years devoted to data collection and 120 to participate to achieve a 
completed sample of 94 patients per site.   
 
Anticipated risks: 
 
The risks of this study are primarily those regarding potential for fatigue from completing the 
questionnaires and the intervention, the emotionally evocative nature of the material shared 
during the course of the intervention, and loss of privacy. The likelihood of these risks is low, as 
has been observed and documented in the many previous studies of DT cited in the 
Background section. 
  
 

6                              Palliative Care for the Elderly Outpatient, May 12, 2020 
 
Anticipated benefits: 
 
There may be no benefit to individual participants in any arm since this study is needed to 
understand how DT can be implemented in a real-world setting and still retain its beneficial 
impacts. A common perception regarding DT is that it has been sufficiently studied that it should 
simply be accepted. However, there is minimal knowledge on how DT fares in the real world 
setting. As our recent systematic review has revealed, results of many feasibility studies are 
very promising, but only one small efficacy study showed significant effects on study outcomes 
whereas the other three completed efficacy studies, one with more than 400 patients, did not 
show significant effects on study outcomes. Our study will fill the gap of inconsistent and 
inconclusive effects, in turn then allowing for the next step of up-scaling implementation. 
 
The multiple feasibility or efficacy studies have shown that DT is greatly appreciated by 
participants, families and healthcare providers. So there seems reason to believe that DT’s 
impact on promoting healthy life transitions will result in a patient benefit for those from either of 
the nurse- or the chaplain-led DT arms.  
 
The study has tremendous potential to inform future studies on DT and advancing DT to clinical 
palliative care practice involving elderly patients with cancer. There tends to be a bias regarding 
psychosocial interventions, which includes the idea that these interventions ought to be 
resource neutral i.e., without any cost whatsoever. However, the availability of resources should 
be driven by efficacy and the evidence to support the application of DT in a given setting. This 
study will provide needed data on how to apply DT in specific services – by the nurse or 
chaplain.  
 
The study also has tremendous potential to help the scientific community understand ways for 
spiritual palliative care services to be implemented systematically to affect patient outcomes and 
care processes. Very few spiritual care interventions have been systematically developed, 
protocolized, and studied. DT is one of them. Until we understand how much of DT’s impact is 
spiritual, we do not know how to use DT as a tool to study spiritual care needs. 
 
The knowledge also has potential to add to the understanding of mechanisms that may 
influence the effect of DT for elderly patients with cancer and receiving palliative care. In 
particular, in our study, we will be including patients from the palliative care service regardless 
of prognosis and so we will have exploratory data on the use of DT for people who have every 
reason to expect to survive for prolonged periods, including promoting the will to survive cancer 
therapies as findings from one small study suggests. 
 
Inclusion criteria: 
 
Criteria for study participation require that the patient: 
(1) has a cancer diagnosis (receiving cancer therapy or cancer control care, responsive to NOT-
CA-14-016) 
(2) is receiving outpatient palliative care 
(3) is age 55 years or older (responsive to PAR-13-354) 
(4) is able to speak and read English 
(5) is physically able to complete the study (Palliative Performance Scale [PPS]>50,6-11 
suggesting a mean in life expectancy of 53 days at the time of enrollment),11 each patient is 
expected to participate in the study for 28-42 days maximum (4-6 weeks). 
 
 
 

7                              Palliative Care for the Elderly Outpatient, May 12, 2020 
 
Exclusion criteria: 
 
Patients will be excluded if they:  
(1) are legally blind 
(2) are cognitively unable to complete study measures (Mini Mental Status Exam [MMSE] does 
not correctly spell the word world backwards)  
(3) have history of psychosis (medical record review) 
(4) have Patient Dignity Inventory and Spiritual Distress scores that indicate their distress levels 
fall outside the remaining quota for a given step (quota is 50% of sample/site/step with low 
distress ≤ 2 problems rated >2 & 50% with high distress ≥ 3 problems rated >2 on each scale) 
(5) are participating in another psychosocial intervention study that is focused on concepts 
similar to the proposed study. 
 
Data collection and management: 
 
This study is an intervention study with data collected before and after the intervention. We will 
obtain data from patients completing self-report questionnaires (dignity impact, existential tasks, 
cancer prognosis awareness, physical symptoms, spiritual distress, death anxiety, satisfaction 
with spiritual care, demographics) on a tablet device connected to the study’s REDCap site. We 
also will obtain data via patient interview (performance, mental status, DT interview) and medical 
record review. The DT interview will be recorded, deposited on a secure server for transcription 
by a qualified transcriptionist and editing by a trained, professional editor. Following upload to 
REDCap, the video-conference recording will be deleted from the device.  
Chaplains will document their usual care in the health record. 
To ensure confidentiality, each subject and provider (nurse or chaplain interventionist) will be 
assigned a code number. All data are coded with the code numbers and linked to the patient’s 
name. The patient’s name is removed from the database when statistical analyses are 
conducted. Demographic information, chart review information, and other self-report outcomes 
are entered into data forms in REDCap, an Internet-based data management system. The 
REDCap system has strong password protection and is located on a reliable and secure 
research server at UF. Access to the server is password restricted and only the pertinent 
research staff can access the data via an application designed for data download. Only the data 
manager and statistician will have authority for direct access to the database server files. 
Participants or study staff will enter data through the REDCap system designed specifically for 
this study on a tablet computer with strong password protection. The team members in the 
Center for Palliative Care Research and Education at the UF are skilled in developing and 
deploying user-friendly, secure, and reliable programs for data collection and tracking. The staff 
members in the nursing information systems office are well-trained and responsible for 
maintaining the network security and adhering to UF policy regarding security for research data 
and protected health information. The UF Health Sciences research servers have firewall 
protection and access through the firewall is restricted and closely monitored. Data on the 
server will be backed up each night; backups are stored nightly in water- and fireproof cabinets. 
The tablets used for data collection will be locked in a secure cabinet when not in use. The 
project statistician will monitor the safety of the data continuously. 
 
Completing the self-report measures and the DT intervention are low risk. Continuous, close 
monitoring by the Multiple Principal Investigators (MPIs) will be an adequate and appropriate 
format for monitoring, with prompt reporting of adverse effects to the IRB and NIH Program 
Officer. As a low-risk study, data monitoring by the MPIs would meet the NIH requirements for 

8                              Palliative Care for the Elderly Outpatient, May 12, 2020 
 
data safety and monitoring for a clinical trial. The co-investigators, site directors, and other team 
members are well positioned clinically to identify any adverse event and report it to the MPI 
Wilkie, who will report it to other MPIs, the IRBs and NIH program officer. 
 
The MPIs (Wilkie, Emanuel, Fitchett) will evaluate the progress of the study, including periodic 
assessments of data quality and timeliness, participant recruitment, accrual and retention, 
participant risk versus benefit, and other factors that could affect study outcomes. The MPIs 
also monitor for scientific or therapeutic developments that may have an impact on the safety of 
the participants or the ethics of the study. The MPIs make recommendations to the IRB and the 
site directors concerning continuation or conclusion of the trial. 
Data analysis: 
 
Data management and preliminary data analysis procedures will be supervised by MPI Wilkie 
and conducted by Dr. Yao, the Co-I and statistician, using statistical software R. Data will be 
stored in a REDCap database and will be exported to R. In the case of missing data, multiple 
imputations will be used to generate multiple complete datasets on which statistical inference 
will be performed. Missing at random assumption will be assessed and if necessary sensitivity 
analysis will be performed using pattern mixture methods. We will consider a p value less than 
.05 as statistically significant.   
 
Descriptive statistics (ranges, frequencies, means, and standard deviations) and graphic 
summary (box plots, histograms, bivariate scatter plots, etc.) will be first generated for both 
patient covariates and outcome measures. We will check patient characteristics to see if there is 
notable imbalance between the three arms, as well as whether there is significant variations 
between sites or over time. Descriptive statistics of patient outcomes and process data will 
reveal patients’ spiritual state, identify potential areas for improvement in nurse and chaplain 
service, and provide information on nurses’ and chaplains’ workload both in usual care and 
when dignity therapy is added and on family-related variables (e.g., legacy document 
disposition, etc.).  
 
 
Aim 1. Linear mixed effects models will be used to compare the effects of usual palliative 
care with usual palliative care with nurse-led and chaplain-led DT groups on (a) patient 
outcomes and (b) processes of delivering palliative spiritual care services. Random effects 
terms will be used to model the variations between sites. A main challenge of data analysis of a 
stepped-wedge design is the modeling of potential time trends. We plan to treat time as a 
continuous variable and utilize smoothing splines to model potential time trends. Smoothing 
splines is a nonparametric method that allows flexibility to model different time trends without 
overfitting by enforcing a smoothness constraint. Likelihood ratio tests will be used to determine 
the statistical significance of the intervention effect on various outcome measures. We 
hypothesize that, controlling for pretest scores, patients in both nurse-led and chaplain-led DT 
groups will have higher dignity impact scores, higher preparation for death and life completion 
scores, better peaceful awareness, and treatment preferences more consistent with their cancer 
prognosis than the usual care groups. We also expect the patients in the DT groups to be more 
satisfied with the palliative care and have fewer unmet spiritual needs than the usual care 
groups. We do not expect significant difference between nurse-led and chaplain-led DT 
interventions. Note that, this does not necessarily mean that the two interventions are equally 
effective. We do not seek to test the equivalence of the two intervention arms. At this point, it is 
premature to speculate on their relative efficacy. We expect most patients in this study to have 
metastatic cancer. If a sizable portion of our sample has non-metastatic cancer, we will explore 
if they respond to DT differently than those with metastatic disease. 

9                              Palliative Care for the Elderly Outpatient, May 12, 2020 
 
 
 
Aim 2. The effect of physical symptoms and spiritual distress on the dignity impact and 
existential tasks will be modeled nonparametrically using smoothing splines. Our models will 
include both main effect for physical symptoms and spiritual distress and their interactions with 
the intervention. This analysis will provide insight on the type of patients most in need of and 
most likely to benefit from the DT intervention. Likelihood ratio tests will be used to determine 
the significance of the interaction. We hypothesize that patients’ levels of spiritual distress and 
physical symptom scores will moderate the intervention effect. 
 
Safety monitoring: 
 
The study is low risk. However, the research team will monitor the safety of subjects during 
study procedures. In the event of injury related to this research, treatment will be available 
through the UF Health or the health system associated with the data collection site. However, 
the patient or third party payer, if any, will be responsible for payment of this treatment. Patient 
subjects will remain under the care of their usual provider, who will be available to give them 
usual care if needed. Any unanticipated problems related to the study procedure will be 
immediately reported to the IRB and NCI Program Officer. 
 
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