Outlook Quality of Life Intervention Study

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 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.

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

Conditions
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Cancer, Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD), End Stage Renal Disease (ESRD)

Intervention / Treatment
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* Other: Life Completion
* Other: Attention Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Advanced cancer Congestive heart failure COPD End stage renal disease Exclusion Criteria: Cognitive impairment inability to speak non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 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

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outlook Intervention<br>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<br>* Subjects discussed 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 listened to a non-guided relaxation CD<br>|
| No Intervention: Treatment as Usual<br>Subjects in the third group (treatment as usual) were exposed to no intervention or attention control during the intervention window. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64) | 
| 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. | 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. | Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, end of life, self-disclosure, palliative care