MedPath

Palliative Care for Elderly Outpatients

Not Applicable
Completed
Conditions
Cancer Terminal
Interventions
Behavioral: Usual care
Behavioral: Dignity Therapy - Nurse Led
Behavioral: Dignity Therapy - Chaplain Led
Registration Number
NCT03209440
Lead Sponsor
University of Florida
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
579
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]).
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Exclusion Criteria
  1. legally blind
  2. cognitively unable to complete study measures (Mini Mental Status Exam [MMSE] does not correctly spell the word world backwards)
  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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
usual outpatient palliative careUsual careDuring the usual care steps, patients will receive usual outpatient palliative care
Dignity Therapy - Nurse LedDignity Therapy - Nurse LedDuring the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.
Dignity Therapy - Chaplain LedDignity Therapy - Chaplain LedDuring the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.
Primary Outcome Measures
NameTimeMethod
Dignity Impact Scale5 weeks

Our primary outcome measure is a 7-item Dignity Impact Scale. The items are scored on a 5-point scale from 'strongly disagree' (1) to 'strongly agree' (5). The scores can range from 7 to 35 with higher scores representing better outcome.

Secondary Outcome Measures
NameTimeMethod
Preparation5 weeks

Preparation for death subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 4 to 20 with higher scores representing better outcomes.

Treatment Preference5 weeks

We measured treatment preferences with a single item from the standardized and validated Hypothetical Advanced Care Planning Scenario (H-CAP-S) that assesses treatment preferences.

Completion5 weeks

Life completion subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 7 to 35 with higher scores representing better outcomes.

Peaceful Awareness5 weeks

We measured peaceful awareness with the 2 items: terminal illness awareness and peaceful awareness questionnaire. The first focused on terminal illness acknowledgement (TIA) in which patients rated their current health status as 1) relatively healthy, 2) seriously but not terminally ill, or 3) seriously and terminally ill. The second item focused on the frequency of feeling deep inner peace or harmony, which was rated on a 6-point Likert scale ranging from 1) never or almost never to 6) many times a day. Scores of at least 3 on each of the two items defined positive peaceful awareness, a dichotomous measure.

Trial Locations

Locations (1)

University of Florida

🇺🇸

Gainesville, Florida, United States

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