Abstract
Background: Our goal is to improve psychosocial and spiritual care outcomes for elderly patients with cancer by optimizing an intervention focused on dignity conservation tasks such as settling relationships, sharing words of love, and preparing a legacy document. These tasks are central needs for elderly patients with cancer. Dignity therapy (DT) has clear feasibility but inconsistent efficacy. DT could be led by nurses or chaplains, the 2 disciplines within palliative care that may be most available to provide this intervention; however, it remains unclear how best it can work in real-life settings. Objective: We propose a randomized clinical trial whose aims are to (1) compare groups receiving usual palliative care for elderly patients with cancer or usual palliative care with DT for effects on (a) patient outcomes (dignity impact, existential tasks, and cancer prognosis awareness); and (b) processes of delivering palliative spiritual care services (satisfaction and unmet spiritual needs); and (2) explore the influence of physical symptoms and spiritual distress on the outcome effects (dignity impact and existential tasks) of usual palliative care and nurse- or chaplain-led DT. We hypothesize that, controlling for pretest scores, each of the DT groups will have higher scores on the dignity impact and existential task 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. We also hypothesize that physical symptoms and spiritual distress will significantly affect intervention effects. Methods: We are conducting a 3-arm, pre- and 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- or chaplain-led DT on 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 United States. Using multilevel analysis with site, provider (nurse, chaplain), and time (step) included in the model, we will compare 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. Results: The funding was obtained in 2016, with participant enrollment starting in 2017. Results are expected in 2021. Conclusions: This rigorous trial of DT will constitute a landmark step in palliative care and spiritual health services research for elderly cancer patients.
Original language | English (US) |
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Article number | e12213 |
Journal | JMIR Research Protocols |
Volume | 8 |
Issue number | 4 |
DOIs | |
State | Published - Apr 2019 |
Funding
This research was made possible by Grant Number 5R01CA200867 from the National Institutes of Health (NIH), National Cancer Institute (NCI) and National Institute of Nursing Research (NINR). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCI or NINR. The final peer-reviewed manuscript is subject to the NIH Public Access Policy. See Multimedia Appendix 1 for NIH review. We have exceptionally strong research and clinical environments to support the proposed study, and a strong, collaborative, interdisciplinary team distinguished by its rare combination of chaplaincy, nursing, and palliative care researchers. We are noted for a history of excellence in palliative care research in elderly cancer patients, including a Templeton Foundation grant to stimulate chaplaincy research in palliative care and several funded R01 level studies focused on palliative care populations. We propose a highly significant and high-quality study in which we will apply rigorous science to an area that sorely needs it: spiritual care research. Studying 560 participants in a pre-and posttest, randomized, controlled 4-step, stepped-wedge design, we will compare the effects of usual outpatient palliative care against the same plus either nurse-led or chaplain-led DT on patient outcomes (dignity impact, existential tasks, and cancer prognosis awareness). Using a multilevel analysis with site, provider (nurse and chaplain), and time (step) in the model, we will determine the efficacy and mechanism of DT when delivered by nurses or chaplains as a spiritual care therapy. Success in this landmark study will yield the first manualized intervention for chaplaincy services, its potential efficacy compared with nurse-led DT, and insights into its mechanisms of action related to spiritual care, an area of great importance to elderly cancer patients receiving palliative care. We will disseminate study findings in a variety of venues for presentation and publication to reach palliative care, oncology, gerontology, chaplaincy, nursing, and other audiences.
Keywords
- Cancer
- Elderly
- Palliative care
- Religion
- Therapy
ASJC Scopus subject areas
- General Medicine