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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outlook Intervention | Experimental | 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. |
|
| 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. |
|
| Treatment as Usual | No Intervention | Subjects in the third group ("treatment as usual") were exposed to no intervention or attention control during the intervention window. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Life Completion | Other | Subjects discussed life review, issues of forgiveness and heritage and legacy. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|
| 25003541 | Background | Steinhauser KE, Voils CI, Bosworth H, Tulsky JA. What constitutes quality of family experience at the end of life? Perspectives from family members of patients who died in the hospital. Palliat Support Care. 2015 Aug;13(4):945-52. doi: 10.1017/S1478951514000807. Epub 2014 Jul 8. | |
| 28803082 | Derived | Steinhauser KE, Alexander S, Olsen MK, Stechuchak KM, Zervakis J, Ammarell N, Byock I, Tulsky JA. Addressing Patient Emotional and Existential Needs During Serious Illness: Results of the Outlook Randomized Controlled Trial. J Pain Symptom Manage. 2017 Dec;54(6):898-908. doi: 10.1016/j.jpainsymman.2017.06.003. Epub 2017 Aug 10. |
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Eligible participants were consented, screened with the Mini Mental Status Exam (MMSE), given a baseline interview, then randomized to group. Reasons for not randomizing participants included death, drop-out, unable to contact, and study removal due to non-eligibility.
A total of 221 patients were recruited from the outpatient clinics and nursing home care unit from the Durham VA Medical Center from 1/2011 to 12/2013. Patients were eligible if they were considered to have serious life-limited disease, identified by clinical criteria, with staging/prognosis confirmed by a provider.
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| ID | Title | Description |
|---|---|---|
| FG000 | Outlook Intervention | Subjects in the first group ("Outlook Intervention") 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. |
| FG001 | Attention Control | Subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD. Attention Control: Subjects will listen to a non-guided relaxation CD |
| FG002 | Arm 3 Treatment as Usual | Subjects in the third group ("treatment as usual") were exposed to no intervention or attention control during the intervention window. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization |
| ||||||||||||||||
| Follow-up 1 |
| ||||||||||||||||
| Follow-Up 2 |
|
A total of 261 Durham VAMC patients with serious life-limiting disease were consented, and 221 were randomized to the study. Seventy-five were randomized to the Life completion intervention, 74 to the active control intervention, and 72 to the usual care control group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 -Outlook Intervention | Subjects in the first group ("Outlook Intervention") completed a psychosocial intervention which consists 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 issues of heritage and legacy. Life Completion: 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64) |
|
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Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
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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 | Outlook Intervention | Subjects in the first group ("Life Completion") will complete a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. 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: Subjects will discuss life review, issues of forgiveness and heritage and legacy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| psychiatric | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Steinhauser, PhD | HSRD, Durham VAMC | 919 668-2148 | karen.steinhauser@duke.edu |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006333 | Heart Failure |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D007676 | Kidney Failure, Chronic |
| D003643 | Death |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Attention Control | Other | Subjects listened to a non-guided relaxation CD |
|
| 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) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Arm 2 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 will listen to a non-guided relaxation CD |
| BG002 | Arm 3 Treatment as Usual | Subjects in the third group ("Treatment as Usual") were exposed to no intervention or attention control during the intervention window. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Palliative Performance Scale - Stratification variable | The Palliative Performance Scale was used to assess functional status of participants. It was used as a stratification variable in randomization to assure that all arms of the trial had equal numbers of participants at similar levels of functional abilities, and illness severity. Scale range is 0 -100 where higher numbers indicate higher function. | Number | participants |
|
| Highest level of Education | Number | participants |
|
| Religion | Number | participants |
|
| Financial Status | Number | participants |
|
| Working Status | Number | participants |
|
Participants received a relaxation meditation as attention control |
| OG002 | Arm 3 Treatment as Usual | Participants received no intervention, but rather care as usual |
|
|
|
| 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 0-20. Higher scores indicate greater anxiety. | Posted | Mean | Standard Deviation | units on a scale | Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64) |
|
|
|
|
| Secondary | 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 (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64) |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (n=75, 74, 72), 5 weeks (61, 59, 60) and 7 weeks (64, 56, 63) |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64) |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64) |
|
|
|
|
| 12 |
| 75 |
| 6 |
| 75 |
| EG001 | 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. | 16 | 74 | 8 | 74 |
| EG002 | Treatment as Usual | Subjects in the third group ("treatment as usual") will be exposed to no intervention or attention control during the intervention window. | 13 | 72 | 6 | 72 |
| death | General disorders | Systematic Assessment |
|
| general | General disorders | Systematic Assessment |
|
| neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| procedural complicaton | Surgical and medical procedures | Systematic Assessment |
|
| psychiatric | Psychiatric disorders | Systematic Assessment |
|
| surgery | Surgical and medical procedures | Systematic Assessment |
|
| respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| renal | Renal and urinary disorders | Systematic Assessment |
|
| vascular | Vascular disorders | Systematic Assessment |
|
| infection | Infections and infestations | Systematic Assessment |
|
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| D012140 |
| Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
|
| 7 Weeks |
|
Comparison at 5 weeks.
| Mixed Models Analysis |
Adjusted for Palliative Performance Scale (low versus high) stratification variable |
| <.97 |
| Mean Difference (Net) |
| -0.02 |
| 2-Sided |
| 95 |
| -1.2 |
| 1.1 |
| No |
| Superiority or Other |
|
| 7 Week |
|
Comparison at 5 weeks
| Mixed Models Analysis |
Adjusted for Palliative Performance Scale (low versus high) stratification variable |
| =.42 |
| Mean Difference (Net) |
| -0.6 |
| 2-Sided |
| 95 |
| -2.1 |
| 0.9 |
| No |
| Superiority or Other |
|
| 7 Weeks |
|
Comparison at 5 weeks.
| Mixed Models Analysis |
Adjusted for Palliative Performance Scale (low versus high) stratification variable. |
| <.97 |
| Mean Difference (Net) |
| .04 |
| 2-Sided |
| 95 |
| -2.1 |
| 2.2 |
| No |
| Superiority or Other |
|
| 7 weeks |
|
Comparison at 5 weeks
| Mixed Models Analysis |
Adjusted for Palliative Performance Scale (low versus high) stratification variable. |
| <.05 |
| Mean Difference (Final Values) |
| 1.6 |
| 2-Sided |
| 95 |
| .05 |
| 3.1 |
| No |
| Superiority or Other |
|
| 7 Weeks |
|
Comparison at 5 weeks.
| Mixed Models Analysis |
Adjusted for Palliative Performance Scale (low versus high) stratification variable. Sex item omitted from scale. |
| =0.055 |
| Mean Difference (Net) |
| 1.4 |
| 2-Sided |
| 95 |
| -0.03 |
| 2.7 |
| No |
| Superiority or Other |