Outlook Quality of Life Intervention
|ClinicalTrials.gov Identifier: NCT00784095|
Recruitment Status : Completed
First Posted : November 3, 2008
Results First Posted : March 22, 2016
Last Update Posted : March 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cancer Congestive Heart Failure Chronic Obstructive Pulmonary Disease||Other: Life completion and preparation Other: Attention Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Outlook: An Intervention to Improve Quality of Life in Serious Illness|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Experimental: Preparation and Completion
Subjects in the first group ("treatment") met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. 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 discussed issues of heritage and legacy.
Other: Life completion and preparation
Subjects will discuss 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 will listen to a non-guided relaxation CD.
No Intervention: True Control
Subjects in the third group ("true control") were exposed to no intervention or attention control.
- Quality of Life - Preparation [ Time Frame: Baseline, 6 and 8 week follow up ]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. The 4-item preparation sub-scale is a primary outcomes measure with each item scaled from 1 to 5 with a minimum of 5, maximum of 20 score with higher scores indicating better preparation.
- QUAL-E Completion Sub-scale [ Time Frame: Baseline, 6 and 8 week follow up ]A sub-scale of the QUAL-E quality of life at the end of life measures. The scale range was 5-35 with higher scores indicating more positive sense of completion.
- Functional Status ADL [ Time Frame: Baseline, 6 and 8 week follow ups ]Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.
- Center for Epidemiology Studies - Depression Scale (CES-D) [ Time Frame: Baseline, 6 and 8 week follow up ]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.
- POMS Anxiety Sub-scale [ Time Frame: Baseline, 6 and 8 week follow ups ]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 5-25. Higher scores indicate greater anxiety.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784095
|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|