The purpose of this study is to determine whether discussions of life story, forgiveness, and future goals improve quality of life for patients with serious illness.
This is a randomized control trial to evaluate the feasibility of the Outlook intervention. 221 veterans with advanced cancer, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) or end stage renal disease (ESRD) were randomly assigned to one of three intervention groups and completed a brief battery of pre-test measures. Subjects in the first group ("Outlook Intervention") were randomized to meet with a facilitator three times for a period of 45 min-1 hour. Participants were asked in the first session to discuss issues related to life review. They were asked in the second session to speak in more depth about issues of regret, forgiveness and things left undone. The subject of the final session was heritage and legacy. Participants in the attention control group were randomized to meet with a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided relaxation audio disc (CD). Participants in the third group ("treatment as usual") were exposed to no interventional sessions. Participants were assessed with post-test measures administered by a blinded interviewer one week and 3 weeks after the intervention window.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
221
Subjects discussed life review, issues of forgiveness and heritage and legacy.
Subjects listened to a non-guided relaxation CD
Durham VA Medical Center HSR&D COE
Durham, North Carolina, United States
QUAL-E - Preparation Sub-scale
Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 4-item preparation sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 5 and maximum was 20 with higher numbers indicating higher preparation.
Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)
QUAL-E Life Completion Sub-scale
Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 7-item life completion sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 7 and maximum was 35 with higher scores indicating greater completion.
Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64)
POMS Anxiety Sub-scale
The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 0-20. Higher scores indicate greater anxiety.
Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64)
CES-D
Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.
Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64)
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FACIT-SP
The Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (Facit-SP) is a 12-item measure of faith, meaning and purpose, with a range of 0 to 48. Higher scores indicate greater spiritual well-being.
Time frame: Baseline (n=75, 74, 72), 5 weeks (61, 59, 60) and 7 weeks (64, 56, 63)
FACT-G - Social Sub-scale
Functional assessment of Cancer Therapy-General) is a 27 item survey which assesses physical, social/family, emotional, and functional well being. This sub-scale assesses social well-being. We omitted an item assessing satisfaction with sex life, due to high missing data. Items are rated on a 5 point likert scale, with 0 indicating "not at all" and 4 indicating, "very much" in response to item questions. Total sub-scale range is 0 to 30, with higher scores indicating better well-being.
Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64)