Outlook Quality of Life Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a pilot randomized control trial to evaluate the feasibility of the Outlook intervention. 36 veterans with advanced cancer, congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD) will be randomly assigned to one of three intervention groups and complete a brief battery of pre-test measures. Subjects in the first group (treatment) will meet with a facilitator three times for a period of 45 min-1 hour. In the first session, subjects will be asked to discuss issues related to life review. In the second session, participants will be asked to speak in more depth about issues such as regret, forgiveness and things left undone, In the final session, subjects will focus on heritage and legacy. The subjects in the second group (attention control) will meet with a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided relaxation compact disk (CD). The third group of participants (true control) will be exposed to no intervention or attention control. One week and two weeks later, participants in all groups will receive post-test measures administered by a blinded interviewer.

Official Title
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Outlook: An Intervention to Improve Quality of Life in Serious Illness

Conditions
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Cancer, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Life completion and preparation
* Other: Attention Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with advanced cancer, CHF or COPD. Exclusion Criteria: Cognitive impairment, inability to speak, non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preparation and Completion<br>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<br>* Subjects will discuss life review, issues of forgiveness and heritage and legacy.<br>|
| Active Comparator: Attention Control<br>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<br>* Subjects will listen to a non-guided relaxation CD.<br>|
| No Intervention: True Control<br>Subjects in the third group (true control) were exposed to no intervention or attention control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - Preparation | 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. | Baseline, 6 and 8 week follow up | 
| QUAL-E Completion Sub-scale | 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. | Baseline, 6 and 8 week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Status ADL | Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability. | Baseline, 6 and 8 week follow ups | 
| Center for Epidemiology Studies - Depression Scale (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. | Baseline, 6 and 8 week follow up | 
| 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 5-25. Higher scores indicate greater anxiety. | Baseline, 6 and 8 week follow ups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life