Outlook Quality of Life Intervention Study
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|ClinicalTrials.gov Identifier: NCT01044290|
Recruitment Status : Completed
First Posted : January 7, 2010
Results First Posted : October 19, 2015
Last Update Posted : November 20, 2015
|Condition or disease||Intervention/treatment|
|Cancer Congestive Heart Failure (CHF) Chronic Obstructive Pulmonary Disease (COPD) End Stage Renal Disease (ESRD)||Other: Life Completion Other: Attention Control|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||221 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Outlook: An Intervention to Improve Quality of Life in Serious Illness Study|
|Study Start Date :||January 2011|
|Primary Completion Date :||February 2014|
|Study Completion Date :||April 2014|
Experimental: Outlook Intervention
Subjects in the first group ("Life Completion") completed a psychosocial intervention which consisted of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy.
Other: Life Completion
Subjects discussed life review, issues of forgiveness and heritage and legacy.
Active Comparator: Attention Control
The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.
Other: Attention Control
Subjects listened to a non-guided relaxation CD
No Intervention: Treatment as Usual
Subjects in the third group ("treatment as usual") were exposed to no intervention or attention control during the intervention window.
- QUAL-E - Preparation Sub-scale [ Time Frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64) ]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.
- QUAL-E Life Completion Sub-scale [ Time Frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64) ]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.
- POMS Anxiety Sub-scale [ Time Frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64) ]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.
- CES-D [ Time Frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64) ]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.
- FACIT-SP [ Time Frame: Baseline (n=75, 74, 72), 5 weeks (61, 59, 60) and 7 weeks (64, 56, 63) ]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.
- FACT-G - Social Sub-scale [ Time Frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044290
|United States, North Carolina|
|Durham VA Medical Center HSR&D COE|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Karen E. Steinhauser, PhD||Durham VA Medical Center HSR&D COE|