Karen E Steinhauser1, Stewart Alexander2, Maren K Olsen3, Karen M Stechuchak4, Jennifer Zervakis4, Natalie Ammarell5, Ira Byock6, James A Tulsky7. 1. Center for Health Services Research in Primary Care Durham VA Medical Center, Durham, North Carolina, USA; Department of Medicine, Division of General Internal Medicine, Duke University, Durham, North Carolina, USA; Palliative Care Section, Duke University, Durham, North Carolina, USA; Center for the Study of Aging and Human Development, Duke University, Durham, North Carolina, USA. Electronic address: karen.steinhauser@duke.edu. 2. College of Health and Human Sciences, Purdue University, West Lafayette, Indiana, USA. 3. Center for Health Services Research in Primary Care Durham VA Medical Center, Durham, North Carolina, USA; Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA. 4. Center for Health Services Research in Primary Care Durham VA Medical Center, Durham, North Carolina, USA. 5. School of Nursing, Duke University, Durham, North Carolina, USA. 6. Providence Institute for Human Caring, Torrance, California, USA; Geisel School of Medicine, Dartmouth University, Hanover, New Hampshire, USA. 7. Dana Farber Cancer Institute, Boston, Massachusetts, USA; Brigham and Women's Hospital, Boston, Massachusetts, USA.
Abstract
CONTEXT: Few interventions exist to address patients' existential needs. OBJECTIVES: Determine whether an intervention to address seriously ill patients' existential concerns improves preparation, completion (elements of quality of life [QOL] at end of life), and reduces anxiety and depression. METHODS: A randomized controlled trial comparing outlook intervention, relaxation meditation (RM), and usual care (UC). Measures included primary-a validated measure of QOL at the end of life and secondary-Functional Assessment of Cancer Therapy-General, anxiety (Profile of Mood States), depression (Center for Epidemiological Studies-Depression Scale), and spiritual well-being (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being). Qualitative interviews assessed outlook intervention acceptability. Enrolled patients were nonhospice eligible veterans with advanced cancer, congestive heart failure, chronic obstructive pulmonary disease, end-stage renal disease, or end-stage liver disease. RESULTS:Patients (n = 221) were randomly assigned 1:1:1 to outlook, RM, and UC. Patients were 96% males, 46% with cancer, 58.4% married, and 43.9% of African American origin. Compared with UC, outlook participants had higher preparation (a validated measure of QOL at the end of life) (mean difference 1.1; 95% CI 0.2, 2.0; P = 0.02) and mean completion (1.6; 95% CI 0.05, 3.1; P = 0.04) at the first but not second postassessment. Compared with RM, outlook participants did not show significant differences over time. Exploratory analyses indicated that in subgroups with cancer and low sense of peace, outlook participants had improved preparation at first and not second postassessment, as compared with UC (mean difference 1.4; 95% CI 0.03, 2.7; P = 0.04) (mean difference = 1.8; 95% CI 0.3, 3.3; P = 0.02), respectively. CONCLUSION: Outlook had an impact on social well-being and preparation compared with UC. The lack of impact on anxiety and depression differs from previous results among hospice patients. Results suggest that outlook is not demonstratively effective in populations not experiencing existential or emotional distress.
RCT Entities:
CONTEXT: Few interventions exist to address patients' existential needs. OBJECTIVES: Determine whether an intervention to address seriously ill patients' existential concerns improves preparation, completion (elements of quality of life [QOL] at end of life), and reduces anxiety and depression. METHODS: A randomized controlled trial comparing outlook intervention, relaxation meditation (RM), and usual care (UC). Measures included primary-a validated measure of QOL at the end of life and secondary-Functional Assessment of Cancer Therapy-General, anxiety (Profile of Mood States), depression (Center for Epidemiological Studies-Depression Scale), and spiritual well-being (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being). Qualitative interviews assessed outlook intervention acceptability. Enrolled patients were nonhospice eligible veterans with advanced cancer, congestive heart failure, chronic obstructive pulmonary disease, end-stage renal disease, or end-stage liver disease. RESULTS:Patients (n = 221) were randomly assigned 1:1:1 to outlook, RM, and UC. Patients were 96% males, 46% with cancer, 58.4% married, and 43.9% of African American origin. Compared with UC, outlook participants had higher preparation (a validated measure of QOL at the end of life) (mean difference 1.1; 95% CI 0.2, 2.0; P = 0.02) and mean completion (1.6; 95% CI 0.05, 3.1; P = 0.04) at the first but not second postassessment. Compared with RM, outlook participants did not show significant differences over time. Exploratory analyses indicated that in subgroups with cancer and low sense of peace, outlook participants had improved preparation at first and not second postassessment, as compared with UC (mean difference 1.4; 95% CI 0.03, 2.7; P = 0.04) (mean difference = 1.8; 95% CI 0.3, 3.3; P = 0.02), respectively. CONCLUSION: Outlook had an impact on social well-being and preparation compared with UC. The lack of impact on anxiety and depression differs from previous results among hospice patients. Results suggest that outlook is not demonstratively effective in populations not experiencing existential or emotional distress.
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