Protocol Summary

Protocol No.: OCR17893

Sponsor Protocol No.: UF-CPS-006; DIGNITY

Protocol Title.: Palliative Care for Elderly Outpatients

Principal Investigator: Wilkie, Diana

Objective: 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.

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.

Phase: N/A

Age Group: Adult

Age: 55 Years - N/A

Gender: All

Scope: National

Treatment:

Active Comparator: usual outpatient palliative care
During the usual care steps, patients will receive usual outpatient palliative care

Experimental: Dignity Therapy - Nurse Led
During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.

Experimental: Dignity Therapy - Chaplain Led
During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.

Detailed Eligibility:

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.

Applicable Conditions:

  • Brain and Nervous System
  • Breast Cancer
  • Colon Cancer
  • Gastrointestinal Cancer
  • Gynecologic Cancer
  • Head & Neck Cancer
  • Hematologic / Bone Marrow Diseases
  • Lung Cancer
  • Nursing
  • Sarcoma
  • Urologic Cancer
  • Participation Institution:

  • Emory University
  • Northwestern University
  • Rush University Medical Center
  • UF Gainesville : Diana Wilkie
  • University of California, San Francisco
  • University of Texas MD Anderson Cancer Center
  • Contact:
    Diana Wilkie
    Email: diwilkie@ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03209440