An interventional study of Life completion and preparation and Attention Control in Cancer, Congestive Heart Failure and Chronic Obstructive Pulmonary Disease, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-22.
Sponsored by VA Office of Research and Development · Not applicable and Interventional
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.
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 36 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with advanced cancer, CHF or COPD.
Exclusion Criteria:
Cognitive impairment, inability to speak, non-English speaking
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
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 in the third group ("true control") were exposed to no intervention or attention control.
Subjects will discuss life review, issues of forgiveness and heritage and legacy.
Subjects will listen to a non-guided relaxation CD.
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.
Time frame: 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.
Time frame: Baseline, 6 and 8 week follow up
Functional Status ADL
Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 and 8 week follow ups
| Milestone | Preparation and Completion | Attention Control | True Control |
|---|---|---|---|
| Started | 12 | 12 | 12 |
| Completed | 12 | 11 | 11 |
| Not completed | 0 | 1 | 1 |
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.
| units on a scale | Preparation and Completion | Attention Control | True Control |
|---|---|---|---|
| Baseline | 14.4 ± 3.9 | 16.0 ± 3.7 | 15.4 ± 4.4 |
| 6 week follow up | 15.2 ± 3.8 | 14.8 ± 5.1 | 14.5 ± 3.9 |
| 8 week follow up | 16.3 ± 2.7 | 16.1 ± 4.6 | 14.5 ± 4.4 |
Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.
| units on a scale | Preparation and Completion | Attention Control | True Control |
|---|---|---|---|
| Baseline | 22.3 ± 4.4 | 21.0 ± 2.3 | 29.7 ± 6.4 |
| 6 week follow up | 23 ± 5.7 | 24 ± 8.1 | 30.6 ± 8.2 |
| 8 week follow up | 23.1 ± 5.3 | 21.8 ± 4.0 | 29.8 ± 8.0 |
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.
| units on a scale | Preparation and Completion | Attention Control | True Control |
|---|---|---|---|
| Baseline | 12.0 ± 5.0 | 12.0 ± 8.3 | 13.4 ± 6.6 |
| 6 week follow up | 12.4 ± 5.4 | 12.6 ± 7.7 | 12.3 ± 6.8 |
| 8 week follow up | 9.4 ± 4.2 | 12.5 ± 8.9 | 12.1 ± 5.9 |
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.
| units on a scale | Preparation and Completion | Attention Control | True Control |
|---|---|---|---|
| Baseline | 5.0 ± 5.5 | 4.1 ± 4.1 | 5.3 ± 4.4 |
| 6 week follow up | 5.1 ± 4.9 | 5.0 ± 4.0 | 5.9 ± 4.4 |
| 8 week follow up | 4.6 ± 3.3 | 4.8 ± 5.4 | 5.3 ± 4.2 |
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.
| units on a scale | Preparation and Completion | Attention Control | True Control |
|---|---|---|---|
| Baseline | 22.4 ± 6.5 | 24.5 ± 5.2 | 22.5 ± 6.9 |
| 6 week follow up | 22.6 ± 5.6 | 25.3 ± 5.2 | 23.1 ± 6.1 |
| 8 week follow up | 23.4 ± 5.6 | 24.1 ± 5.9 | 24.4 ± 7.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Preparation and Completion | — | 0/12 (0%) | 0/12 (0%) |
| Attention Control | — | 1/12 (8.3%) | 0/12 (0%) |
| True Control | — | 0/12 (0%) | 0/12 (0%) |
| Event | Preparation and Completion | Attention Control | True Control |
|---|---|---|---|
| DeathGeneral disorders | 0/12 | 1/12 | 0/12 |
| Age, Continuous(years) | Preparation and Completion | Attention Control | True Control | Total |
|---|---|---|---|---|
| Mean | 64 ± 10 | 68 ± 10 | 69 ± 14 | 67 ± 11 |
| Sex: Female, Male(Participants) | Preparation and Completion | Attention Control | True Control | Total |
|---|---|---|---|---|
| Female | 0 | 1 | 0 | 1 |
| Male | 12 | 11 | 12 | 35 |
| Race (NIH/OMB)(Participants) | Preparation and Completion | Attention Control | True Control | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 4 | 14 |
| White | 7 | 5 | 5 | 17 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 3 | 5 |
| Region of Enrollment(participants) | Preparation and Completion | Attention Control | True Control | Total |
|---|---|---|---|---|
| United States | 12 | 12 | 12 | 36 |
Plan to share: No
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