Outlook Quality of Life Intervention
March 11, 2016 updated by: VA Office of Research and Development
Outlook: An Intervention to Improve Quality of Life in Serious Illness
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27705
- Durham VA Medical Center HSR&D COE
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients with advanced cancer, CHF or COPD.
Exclusion Criteria:
Cognitive impairment, inability to speak, non-English speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Subjects will listen to a non-guided relaxation CD.
|
|
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.
|
Subjects will discuss life review, issues of forgiveness and heritage and legacy.
|
|
No Intervention: True Control
Subjects in the third group ("true control") were exposed to no intervention or attention control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline, 6 and 8 week follow up
|
|
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.
|
Baseline, 6 and 8 week follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 6 and 8 week follow ups
|
|
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.
|
Baseline, 6 and 8 week follow up
|
|
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.
|
Baseline, 6 and 8 week follow ups
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Karen E. Steinhauser, PhD, Durham VA Medical Center HSR&D COE
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
October 30, 2008
First Submitted That Met QC Criteria
October 30, 2008
First Posted (Estimate)
November 2, 2008
Study Record Updates
Last Update Posted (Estimate)
March 22, 2016
Last Update Submitted That Met QC Criteria
March 11, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IAD 07-162
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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