Abstract
BackgroundOur 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.ObjectiveWe 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.MethodsWe 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.ResultsThe funding was obtained in 2016, with participant enrollment starting in 2017. Results are expected in 2021.ConclusionsThis rigorous trial of DT will constitute a landmark step in palliative care and spiritual health services research for elderly cancer patients.Trial RegistrationClinicalTrials.gov NCT03209440; https://clinicaltrials.gov/ct2/show/NCT03209440International Registered Report Identifier (IRRID)DERR1-10.2196/12213
Highlights
Our long-term goal is to improve spiritual care outcomes for elderly patients with cancer
Taking a spiritual perspective for reanalysis of data from the 1 large randomized controlled trial (RCT) [1], we found that compared with usual care, patients who received dignity therapy (DT) reported significantly higher dignity impact ratings [5], which is consistent with the DT focus on meaning making, preparation for death, and life-completion tasks
Evidence from our pilot study suggests that awareness of cancer prognosis outcomes and will-to-live is facilitated by DT [6]
Summary
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 hypothesize that physical symptoms and spiritual distress will significantly affect intervention effects. JMIR Res Protoc 2019 | vol 8 | iss. 4 | e12213 | p. 1 (page number not for citation purposes)
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