Spots Global Cancer Trial Database for Palliative Care for Elderly Outpatients
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Trial Identification
Brief Title: Palliative Care for Elderly Outpatients
Official Title: Palliative Care for Elderly Outpatients
Study ID: NCT03209440
Conditions
Study Description
Brief Summary: 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Florida, Gainesville, Florida, United States
Contact Details
Name: Diana J Wilkie, PhD
Affiliation: University of Florida
Role: PRINCIPAL_INVESTIGATOR
Name: Tammi Quest, MD
Affiliation: Emory University
Role: STUDY_DIRECTOR
Name: George Fitchett, PhD
Affiliation: Rush University
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Rabow, MD
Affiliation: University of California, San Francisco
Role: STUDY_DIRECTOR
Name: Linda Emanuel, MD/PhD
Affiliation: Northwestern University
Role: PRINCIPAL_INVESTIGATOR
Name: Marvin Delgado, MD
Affiliation: MD Anderson
Role: STUDY_DIRECTOR
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