Palliative Care for Elderly Outpatients



Status:Recruiting
Healthy:No
Age Range:55 - Any
Updated:1/2/2019
Start Date:July 26, 2017
End Date:September 2021
Contact:Diana J Wilkie, PhD
Email:diwilkie@ufl.edu
Phone:352-273-6401

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Our long-term goal is to improve spiritual care outcomes for elderly patients with cancer.
The study team 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.

The study team propose a 3 arm pre/posttest, RCT with a 4-step (approximately 12 months per
step), stepped-wedge design 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,
cancer prognosis awareness. The study team 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 and satisfaction with
palliative spiritual care services, receive usual palliative care, and complete posttest
measures. 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, the study team 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. The
study team 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.

Inclusion Criteria:

1. cancer diagnosis (receiving cancer therapy or cancer control care)

2. receiving outpatient palliative care

3. age 55 years or older

4. able to speak and read English

5. physically able to complete the study (Palliative Performance Scale [PPS]>50,
suggesting a mean in life expectancy of 53 days at the time of enrollment since each
patient is expected to participate in the study for 28-42 days maximum [4-6 weeks]).

Exclusion Criteria:

1. legally blind

2. cognitively unable to complete study measures (Mini Mental Status Exam [MMSE] <24)

3. history of psychosis (medical record review)

4. Patient Dignity Inventory score that indicates their distress level falls 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)

5. Spiritual distress score that indicates their distress level falls 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)

6. are participating in another psychosocial intervention study that is focused on
concepts similar to the proposed study.
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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