Dignity Therapy Led by Nurses or Chaplains for Elderly Cancer Palliative Care Outpatients: Protocol for a Randomized Controlled Trial.
cancer
elderly, religion, therapy
palliative care
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
17 Apr 2019
17 Apr 2019
Historique:
received:
17
09
2018
accepted:
31
12
2018
revised:
31
12
2018
entrez:
18
4
2019
pubmed:
18
4
2019
medline:
18
4
2019
Statut:
epublish
Résumé
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. 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. 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. The funding was obtained in 2016, with participant enrollment starting in 2017. Results are expected in 2021. This rigorous trial of DT will constitute a landmark step in palliative care and spiritual health services research for elderly cancer patients. ClinicalTrials.gov NCT03209440; https://clinicaltrials.gov/ct2/show/NCT03209440. DERR1-10.2196/12213.
Sections du résumé
BACKGROUND
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
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
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
RESULTS
The funding was obtained in 2016, with participant enrollment starting in 2017. Results are expected in 2021.
CONCLUSIONS
CONCLUSIONS
This rigorous trial of DT will constitute a landmark step in palliative care and spiritual health services research for elderly cancer patients.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT03209440; https://clinicaltrials.gov/ct2/show/NCT03209440.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/12213.
Identifiants
pubmed: 30994466
pii: v8i4e12213
doi: 10.2196/12213
pmc: PMC6492061
doi:
Banques de données
ClinicalTrials.gov
['NCT03209440']
Types de publication
Journal Article
Langues
eng
Pagination
e12213Subventions
Organisme : NCI NIH HHS
ID : R01 CA200867
Pays : United States
Informations de copyright
©Sheri Kittelson, Lisa Scarton, Paige Barker, Joshua Hauser, Sean O'Mahony, Michael Rabow, Marvin Delgado Guay, Tammie E Quest, Linda Emanuel, George Fitchett, George Handzo, Yingewi Yao, Harvey Max Chochinov, Diana Wilkie. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 17.04.2019.
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