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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preparation and Completion | Experimental | 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. |
|
| Attention Control | Active Comparator | 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. |
|
| True Control | No Intervention | Subjects in the third group ("true control") were exposed to no intervention or attention control. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Life completion and preparation | Other | Subjects will discuss life review, issues of forgiveness and heritage and legacy. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Patients with advanced cancer, CHF or COPD.
Exclusion Criteria:
Cognitive impairment, inability to speak, non-English speaking
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| Name | Affiliation | Role |
|---|---|---|
| Karen E. Steinhauser, PhD | Durham VA Medical Center HSR&D COE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center HSR&D COE | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24803020 | Background | Sautter JM, Tulsky JA, Johnson KS, Olsen MK, Burton-Chase AM, Lindquist JH, Zimmerman S, Steinhauser KE. Caregiver experience during advanced chronic illness and last year of life. J Am Geriatr Soc. 2014 Jun;62(6):1082-90. doi: 10.1111/jgs.12841. Epub 2014 May 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Preparation and Completion | Subjects in the first group ("treatment")will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy. Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy. |
| FG001 | Attention Control | The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD. Attention Control: Subjects will listen to a non-guided relaxation CD. |
| FG002 | True Control | Subjects in the third group ("true control") will be exposed to no intervention or attention control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preparation and Completion | Subjects in the first group ("treatment")will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy. Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 and 8 week follow up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preparation and Completion | Subjects in the first group ("treatment") met with the facilitator three times for a period of forty-five minutes to one our. 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. Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | All patients in the trial were had advanced life-limiting illness. This was deemed not to be an unexpected event. |
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Therefore, due to the small sample size, finding are met with caution. Subjects were not randomized by any condition. As a result, those in the Control arm were more functionally able than the other two arms at baseline.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Steinhauser | VA Health Services Research and Development | 9196682148 | karen.steinhauser@va.gov |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006333 | Heart Failure |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Attention Control | Other | Subjects will listen to a non-guided relaxation CD. |
|
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 |
| BG001 | Attention Control | The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD. Attention Control: Subjects will listen to a non-guided relaxation CD. |
| BG002 | True Control | Subjects in the third group ("true control") will be exposed to no intervention or attention control. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Attention Control | The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD. Attention Control: Subjects will listen to a non-guided relaxation CD. |
| OG002 | True Control | Subjects in the third group ("true control") will be exposed to no intervention or attention control. |
|
|
|
| Secondary | Functional Status ADL | Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 and 8 week follow ups |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 and 8 week follow up |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 and 8 week follow ups |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 and 8 week follow up |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Attention Control | The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD. Attention Control: Subjects listened to a non-guided relaxation CD. | 1 | 12 | 0 | 12 |
| EG002 | True Control | Subjects in the third group ("true control") were exposed to no intervention or attention control. | 0 | 12 | 0 | 12 |
|
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| D012140 |
| Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| 8 week follow up |
|
| Mean Difference (Final Values) |
| -1.1 |
| 2-Sided |
| 95 |
| -5.6 |
| 3.3 |
| No |
| Superiority or Other |
|
| 8 week follow up |
|
| Mean Difference (Final Values) |
| -3.6 |
| 2-Sided |
| 95 |
| -8.2 |
| 1.0 |
| No |
| Superiority or Other |
|
| 8 week follow up |
|
| Mean Difference (Final Values) |
| -1.1 |
| 2-Sided |
| 95 |
| -5.1 |
| 3.0 |
| No |
| Superiority or Other |
|
| 8 week follow up |
|
| Mean Difference (Final Values) |
| 2.4 |
| 2-Sided |
| 95 |
| -1.9 |
| 6.7 |
| No |
| Superiority or Other |