Cancer, Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), End Stage Renal Disease (ESRD)
Conditions
Keywords
quality of life, end of life, self-disclosure, palliative care
Brief summary
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
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.
Interventions
OTHERLife Completion
Subjects discussed life review, issues of forgiveness and heritage and legacy.
OTHERAttention Control
Subjects listened to a non-guided relaxation CD
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Patients with * Advanced cancer * Congestive heart failure * COPD * End stage renal disease
Exclusion criteria
* Cognitive impairment * inability to speak * non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QUAL-E - Preparation Sub-scale | Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64) | 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. |
| QUAL-E Life Completion Sub-scale | Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| POMS Anxiety Sub-scale | Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64) | 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. |
| CES-D | Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64) | 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. |
| FACIT-SP | Baseline (n=75, 74, 72), 5 weeks (61, 59, 60) and 7 weeks (64, 56, 63) | 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. |
| FACT-G - Social Sub-scale | Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 75 |
| 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 | 74 |
| 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. | 72 |
| Total | 221 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Follow-up 1 | Death | 3 | 3 | 1 |
| Follow-up 1 | Withdrawal by Subject | 2 | 2 | 0 |
| Follow-Up 2 | Death | 0 | 1 | 1 |
| Follow-Up 2 | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Arm 1 -Outlook Intervention | Arm 2 Attention Control | Arm 3 Treatment as Usual | Total |
|---|---|---|---|---|
| Age, Continuous | 68.7 years STANDARD_DEVIATION 9.4 | 68.2 years STANDARD_DEVIATION 9.8 | 66.4 years STANDARD_DEVIATION 8.3 | 67.8 years STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 73 Participants | 70 Participants | 218 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Financial Status Difficulty paying the bills | 12 participants | 14 participants | 10 participants | 36 participants |
| Financial Status Have enough money for special things | 18 participants | 16 participants | 21 participants | 55 participants |
| Financial Status Money to pay bills but need to cut back | 20 participants | 19 participants | 19 participants | 58 participants |
| Financial Status Pay bills but little spare money | 25 participants | 25 participants | 22 participants | 72 participants |
| Highest level of Education Bachelor's degree | 8 participants | 4 participants | 9 participants | 21 participants |
| Highest level of Education HS degree or GED | 25 participants | 29 participants | 25 participants | 79 participants |
| Highest level of Education Less than High School (HS) degree | 6 participants | 7 participants | 8 participants | 21 participants |
| Highest level of Education Some college, associate, trade school | 31 participants | 29 participants | 24 participants | 84 participants |
| Highest level of Education some graduate/professional or higher degree | 5 participants | 5 participants | 6 participants | 16 participants |
| Palliative Performance Scale - Stratification variable High (greater or = 70) | 55 participants | 55 participants | 54 participants | 164 participants |
| Palliative Performance Scale - Stratification variable Low (less or = 60) | 20 participants | 19 participants | 18 participants | 57 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 31 Participants | 28 Participants | 97 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 42 Participants | 39 Participants | 117 Participants |
| Region of Enrollment United States | 75 participants | 74 participants | 72 participants | 221 participants |
| Religion Christian | 72 participants | 69 participants | 62 participants | 203 participants |
| Religion Missing | 0 participants | 1 participants | 2 participants | 3 participants |
| Religion Not a member of a religion | 2 participants | 3 participants | 5 participants | 10 participants |
| Religion Other | 1 participants | 1 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 74 Participants | 68 Participants | 70 Participants | 212 Participants |
| Sex: Female, Male Male | 1 Participants | 6 Participants | 2 Participants | 9 Participants |
| Working Status Disability | 23 participants | 20 participants | 18 participants | 61 participants |
| Working Status Not working | 4 participants | 6 participants | 9 participants | 19 participants |
| Working Status Retired | 44 participants | 41 participants | 41 participants | 126 participants |
| Working Status Working for pay, part or full-time | 4 participants | 7 participants | 4 participants | 15 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 75 | 8 / 74 | 6 / 72 |
| serious Total, serious adverse events | 12 / 75 | 16 / 74 | 13 / 72 |
Outcome results
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.
Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 -Outlook Intervention | QUAL-E Life Completion Sub-scale | 5 weeks | 26.6 units on a scale | Standard Deviation 4.6 |
| Arm 1 -Outlook Intervention | QUAL-E Life Completion Sub-scale | Baseline | 26.0 units on a scale | Standard Deviation 5.3 |
| Arm 1 -Outlook Intervention | QUAL-E Life Completion Sub-scale | 7 weeks | 26.1 units on a scale | Standard Deviation 5.1 |
| Arm 2 Attention Control | QUAL-E Life Completion Sub-scale | 5 weeks | 26.4 units on a scale | Standard Deviation 5.7 |
| Arm 2 Attention Control | QUAL-E Life Completion Sub-scale | Baseline | 26.4 units on a scale | Standard Deviation 5.7 |
| Arm 2 Attention Control | QUAL-E Life Completion Sub-scale | 7 weeks | 27.5 units on a scale | Standard Deviation 4.9 |
| Arm 3 Treatment as Usual | QUAL-E Life Completion Sub-scale | Baseline | 25.8 units on a scale | Standard Deviation 5.4 |
| Arm 3 Treatment as Usual | QUAL-E Life Completion Sub-scale | 7 weeks | 25.6 units on a scale | Standard Deviation 4.8 |
| Arm 3 Treatment as Usual | QUAL-E Life Completion Sub-scale | 5 weeks | 25.6 units on a scale | Standard Deviation 6 |
Comparison: Comparison at 5 weeksp-value: 0.2595% CI: [-0.6, 2.4]Mixed Models Analysis
Comparison: Comparison at 5 weeksp-value: <0.0595% CI: [0.05, 3.1]Mixed Models Analysis
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.
Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 -Outlook Intervention | QUAL-E - Preparation Sub-scale | 5 week follow up | 16.0 units on a scale | Standard Deviation 3.1 |
| Arm 1 -Outlook Intervention | QUAL-E - Preparation Sub-scale | Baseline mean | 15.7 units on a scale | Standard Deviation 3.3 |
| Arm 1 -Outlook Intervention | QUAL-E - Preparation Sub-scale | 7 week follow up | 15.5 units on a scale | Standard Deviation 3.2 |
| Arm 2 Attention Control | QUAL-E - Preparation Sub-scale | 5 week follow up | 15.5 units on a scale | Standard Deviation 3.3 |
| Arm 2 Attention Control | QUAL-E - Preparation Sub-scale | Baseline mean | 14.5 units on a scale | Standard Deviation 3.5 |
| Arm 2 Attention Control | QUAL-E - Preparation Sub-scale | 7 week follow up | 15.2 units on a scale | Standard Deviation 3.5 |
| Arm 3 Treatment as Usual | QUAL-E - Preparation Sub-scale | Baseline mean | 14.8 units on a scale | Standard Deviation 3.9 |
| Arm 3 Treatment as Usual | QUAL-E - Preparation Sub-scale | 7 week follow up | 14.6 units on a scale | Standard Deviation 3.5 |
| Arm 3 Treatment as Usual | QUAL-E - Preparation Sub-scale | 5 week follow up | 14.4 units on a scale | Standard Deviation 3.9 |
Comparison: Comparison at 5 weeksp-value: <0.6195% CI: [-1.1, 0.7]Mixed Models Analysis
Comparison: Comparison at 5 weeks.p-value: <0.0295% CI: [0.2, 2]Mixed Models Analysis
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.
Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 -Outlook Intervention | CES-D | 7 Week | 8.8 units on a scale | Standard Deviation 5.1 |
| Arm 1 -Outlook Intervention | CES-D | Baseline | 7.9 units on a scale | Standard Deviation 5.4 |
| Arm 1 -Outlook Intervention | CES-D | 5 week | 8.1 units on a scale | Standard Deviation 5 |
| Arm 2 Attention Control | CES-D | 7 Week | 9.2 units on a scale | Standard Deviation 6.3 |
| Arm 2 Attention Control | CES-D | 5 week | 8.4 units on a scale | Standard Deviation 5.2 |
| Arm 2 Attention Control | CES-D | Baseline | 8.9 units on a scale | Standard Deviation 5.8 |
| Arm 3 Treatment as Usual | CES-D | 7 Week | 9.6 units on a scale | Standard Deviation 5.5 |
| Arm 3 Treatment as Usual | CES-D | 5 week | 9.2 units on a scale | Standard Deviation 6.5 |
| Arm 3 Treatment as Usual | CES-D | Baseline | 9.4 units on a scale | Standard Deviation 6.1 |
Comparison: Comparison at 5 weeksp-value: <0.9195% CI: [-1.4, 1.5]Mixed Models Analysis
Comparison: Comparison at 5 weeksp-value: =0.4295% CI: [-2.1, 0.9]Mixed Models Analysis
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.
Time frame: Baseline (n=75, 74, 72), 5 weeks (61, 59, 60) and 7 weeks (64, 56, 63)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 -Outlook Intervention | FACIT-SP | 5 Weeks | 34.6 units on a scale | Standard Deviation 7.6 |
| Arm 1 -Outlook Intervention | FACIT-SP | Baselin | 34.5 units on a scale | Standard Deviation 8 |
| Arm 1 -Outlook Intervention | FACIT-SP | 7 Weeks | 34.8 units on a scale | Standard Deviation 8 |
| Arm 2 Attention Control | FACIT-SP | 5 Weeks | 33.8 units on a scale | Standard Deviation 8.5 |
| Arm 2 Attention Control | FACIT-SP | Baselin | 33.6 units on a scale | Standard Deviation 9.1 |
| Arm 2 Attention Control | FACIT-SP | 7 Weeks | 34.2 units on a scale | Standard Deviation 8.4 |
| Arm 3 Treatment as Usual | FACIT-SP | Baselin | 32.8 units on a scale | Standard Deviation 8.8 |
| Arm 3 Treatment as Usual | FACIT-SP | 7 Weeks | 33.9 units on a scale | Standard Deviation 9 |
| Arm 3 Treatment as Usual | FACIT-SP | 5 Weeks | 33.9 units on a scale | Standard Deviation 9.6 |
Comparison: Comparison at 5 weeksp-value: =0.5895% CI: [-1.5, 2.8]Mixed Models Analysis
Comparison: Comparison at 5 weeks.p-value: <0.9795% CI: [-2.1, 2.2]Mixed Models Analysis
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.
Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 -Outlook Intervention | FACT-G - Social Sub-scale | 5 Weeks | 18.4 units on a scale | Standard Deviation 5.2 |
| Arm 1 -Outlook Intervention | FACT-G - Social Sub-scale | Baseline | 18.0 units on a scale | Standard Deviation 4.9 |
| Arm 1 -Outlook Intervention | FACT-G - Social Sub-scale | 7 Weeks | 18.5 units on a scale | Standard Deviation 4.6 |
| Arm 2 Attention Control | FACT-G - Social Sub-scale | 5 Weeks | 17.6 units on a scale | Standard Deviation 4.8 |
| Arm 2 Attention Control | FACT-G - Social Sub-scale | Baseline | 17.4 units on a scale | Standard Deviation 4.5 |
| Arm 2 Attention Control | FACT-G - Social Sub-scale | 7 Weeks | 18.3 units on a scale | Standard Deviation 4.7 |
| Arm 3 Treatment as Usual | FACT-G - Social Sub-scale | Baseline | 17.4 units on a scale | Standard Deviation 5.1 |
| Arm 3 Treatment as Usual | FACT-G - Social Sub-scale | 7 Weeks | 16.7 units on a scale | Standard Deviation 5.7 |
| Arm 3 Treatment as Usual | FACT-G - Social Sub-scale | 5 Weeks | 17.1 units on a scale | Standard Deviation 5 |
Comparison: Comparison at 5 weeks.p-value: <0.5795% CI: [-1, 1.8]Mixed Models Analysis
Comparison: Comparison at 5 weeks.p-value: =0.05595% CI: [-0.03, 2.7]Mixed Models Analysis
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.
Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 -Outlook Intervention | POMS Anxiety Sub-scale | 7 Weeks | 5.9 units on a scale | Standard Deviation 4.1 |
| Arm 1 -Outlook Intervention | POMS Anxiety Sub-scale | 5 Weeks | 5.4 units on a scale | Standard Deviation 3.8 |
| Arm 1 -Outlook Intervention | POMS Anxiety Sub-scale | Baseline | 5.5 units on a scale | Standard Deviation 4.5 |
| Arm 2 Attention Control | POMS Anxiety Sub-scale | 7 Weeks | 5.3 units on a scale | Standard Deviation 3.8 |
| Arm 2 Attention Control | POMS Anxiety Sub-scale | Baseline | 5.9 units on a scale | Standard Deviation 4.1 |
| Arm 2 Attention Control | POMS Anxiety Sub-scale | 5 Weeks | 5.6 units on a scale | Standard Deviation 4.1 |
| Arm 3 Treatment as Usual | POMS Anxiety Sub-scale | 5 Weeks | 5.9 units on a scale | Standard Deviation 4.6 |
| Arm 3 Treatment as Usual | POMS Anxiety Sub-scale | Baseline | 6.5 units on a scale | Standard Deviation 4.6 |
| Arm 3 Treatment as Usual | POMS Anxiety Sub-scale | 7 Weeks | 6.7 units on a scale | Standard Deviation 4.7 |
Comparison: Comparison at 5 weeksp-value: =0.995% CI: [-1.2, 1.1]Mixed Models Analysis
Comparison: Comparison at 5 weeks.p-value: <0.9795% CI: [-1.2, 1.1]Mixed Models Analysis