Dignity Therapy RCT led by Nurses or Chaplains or Elderly Cancer Outpatients

• PI: Diana J. Wilkie, PhD (University of Florida)
• Site PI: Tammie E. Quest, MD
• Funder: National Institutes of Health; National Cancer Institute
• Total Project Budget: $712,498

Summary

Our long-term goal is to improve spiritual care outcomes for elderly patients facing a cancer diagnosis. We will use a nurse-led or chaplain-led intervention, Dignity Therapy (DT), focused on dignity conservation tasks such as settling relationships, sharing words of love, and preparing for separation by death. These tasks are central needs for elderly patients with cancer, but it is not clear if DT should be led by nurses or chaplains, the two disciplines within palliative care most available to provide DT.

We propose a 3-arm, 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 either nurse-led or chaplain-led DT on pilot-tested patient outcomes (dignity impact, existential tasks, and cancer prognosis awareness).

We will include 560 elderly patients with cancer from 6 outpatient palliative care services across the U.S. We will assign the 6 sites to usual care in the first-step period (12 months), and randomly assign 2 sites per step to begin and continue DT led either by a nurse or a chaplain during each of the next three steps. During usual care steps, 280 patients will complete pretest measures (patient outcomes, processes, covariates [physical symptoms, spiritual distress]), receive usual chaplain care, and 4-6 weeks later will complete posttest measures. During experimental steps as part of routine palliative care, 280 patients will complete pretest measures, receive nurse-led or chaplain-led DT, and 4-6 weeks later will complete posttest measures. Process measures will be completed during all steps. Using mixed-level analysis with the site, provider (nurse, chaplain), and time (step) included in the model, we will compare the usual care and DT groups for effects on patient outcomes and spiritual care processes and determine the moderating effects of physical symptoms and spiritual distress. Specific aims  are to:

1. Compare usual palliative care and usual palliative care with DT (nurse-led, chaplain-led) groups for effects on:
   1. Patient outcomes (dignity impact, existential tasks, and cancer prognosis awareness). We hypothesize that controlling for pretest scores, each of the DT groups will have higher scores on the dignity impact and existential tasks measures than the usual care group; each of the DT groups will have better peaceful awareness and treatment preference more consistent with their cancer prognosis than the usual care group
   2. Processes of delivering palliative spiritual care services (satisfaction, unmet spiritual needs). We hypothesize that the DT groups will show increased patient satisfaction with spiritual care services and fewer unmet spiritual needs compared to the usual care group.
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 palliative care and spiritual health services research.