Cancer, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure
Conditions
Keywords
quality of life
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 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.
Interventions
OTHERLife completion and preparation
Subjects will discuss life review, issues of forgiveness and heritage and legacy.
OTHERAttention Control
Subjects will listen to a non-guided relaxation CD.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with advanced cancer, CHF or COPD.
Exclusion criteria
Cognitive impairment, inability to speak, non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - Preparation | 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. |
| QUAL-E Completion Sub-scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Status ADL | Baseline, 6 and 8 week follow ups | Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability. |
| Center for Epidemiology Studies - Depression Scale (CES-D) | 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. |
| POMS Anxiety Sub-scale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 12 |
| True Control Subjects in the third group (true control) will be exposed to no intervention or attention control. | 12 |
| Total | 36 |
Baseline characteristics
| Characteristic | Preparation and Completion | Total | True Control | Attention Control |
|---|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 10 | 67 years STANDARD_DEVIATION 11 | 69 years STANDARD_DEVIATION 14 | 68 years STANDARD_DEVIATION 10 |
| 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 | 5 Participants | 14 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 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 | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 7 Participants | 17 Participants | 5 Participants | 5 Participants |
| Region of Enrollment United States | 12 participants | 36 participants | 12 participants | 12 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 12 Participants | 35 Participants | 12 Participants | 11 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 | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 1 / 12 | 0 / 12 |
Outcome results
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.
Time frame: Baseline, 6 and 8 week follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preparation and Completion | QUAL-E Completion Sub-scale | 6 week follow up | 22.6 units on a scale | Standard Deviation 5.6 |
| Preparation and Completion | QUAL-E Completion Sub-scale | Baseline | 22.4 units on a scale | Standard Deviation 6.5 |
| Preparation and Completion | QUAL-E Completion Sub-scale | 8 week follow up | 23.4 units on a scale | Standard Deviation 5.6 |
| Attention Control | QUAL-E Completion Sub-scale | 6 week follow up | 25.3 units on a scale | Standard Deviation 5.2 |
| Attention Control | QUAL-E Completion Sub-scale | Baseline | 24.5 units on a scale | Standard Deviation 5.2 |
| Attention Control | QUAL-E Completion Sub-scale | 8 week follow up | 24.1 units on a scale | Standard Deviation 5.9 |
| True Control | QUAL-E Completion Sub-scale | Baseline | 22.5 units on a scale | Standard Deviation 6.9 |
| True Control | QUAL-E Completion Sub-scale | 8 week follow up | 24.4 units on a scale | Standard Deviation 7.7 |
| True Control | QUAL-E Completion Sub-scale | 6 week follow up | 23.1 units on a scale | Standard Deviation 6.1 |
Comparison: Intervention (Preparation and Completion) versus True Control at 8 weeks95% CI: [-4.8, 3.7]
Comparison: Intervention (Preparation and Completion) versus Attention Control at 8 weeks.95% CI: [-1.9, 6.7]
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.
Time frame: Baseline, 6 and 8 week follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preparation and Completion | Quality of Life - Preparation | 6 week follow up | 15.2 units on a scale | Standard Deviation 3.8 |
| Preparation and Completion | Quality of Life - Preparation | Baseline | 14.4 units on a scale | Standard Deviation 3.9 |
| Preparation and Completion | Quality of Life - Preparation | 8 week follow up | 16.3 units on a scale | Standard Deviation 2.7 |
| Attention Control | Quality of Life - Preparation | 6 week follow up | 14.8 units on a scale | Standard Deviation 5.1 |
| Attention Control | Quality of Life - Preparation | Baseline | 16.0 units on a scale | Standard Deviation 3.7 |
| Attention Control | Quality of Life - Preparation | 8 week follow up | 16.1 units on a scale | Standard Deviation 4.6 |
| True Control | Quality of Life - Preparation | Baseline | 15.4 units on a scale | Standard Deviation 4.4 |
| True Control | Quality of Life - Preparation | 8 week follow up | 14.5 units on a scale | Standard Deviation 4.4 |
| True Control | Quality of Life - Preparation | 6 week follow up | 14.5 units on a scale | Standard Deviation 3.9 |
Comparison: Intervention (Preparation and Completion) versus True Control at 8 weeksp-value: 0.04795% CI: [0.04, 5.7]Mixed Models Analysis
Comparison: Intervention (Preparation and Completion) versus Attention Control at 8 weeks95% CI: [-1.1, 4.7]
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.
Time frame: Baseline, 6 and 8 week follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preparation and Completion | Center for Epidemiology Studies - Depression Scale (CES-D) | 6 week follow up | 12.4 units on a scale | Standard Deviation 5.4 |
| Preparation and Completion | Center for Epidemiology Studies - Depression Scale (CES-D) | Baseline | 12.0 units on a scale | Standard Deviation 5 |
| Preparation and Completion | Center for Epidemiology Studies - Depression Scale (CES-D) | 8 week follow up | 9.4 units on a scale | Standard Deviation 4.2 |
| Attention Control | Center for Epidemiology Studies - Depression Scale (CES-D) | 6 week follow up | 12.6 units on a scale | Standard Deviation 7.7 |
| Attention Control | Center for Epidemiology Studies - Depression Scale (CES-D) | Baseline | 12.0 units on a scale | Standard Deviation 8.3 |
| Attention Control | Center for Epidemiology Studies - Depression Scale (CES-D) | 8 week follow up | 12.5 units on a scale | Standard Deviation 8.9 |
| True Control | Center for Epidemiology Studies - Depression Scale (CES-D) | Baseline | 13.4 units on a scale | Standard Deviation 6.6 |
| True Control | Center for Epidemiology Studies - Depression Scale (CES-D) | 8 week follow up | 12.1 units on a scale | Standard Deviation 5.9 |
| True Control | Center for Epidemiology Studies - Depression Scale (CES-D) | 6 week follow up | 12.3 units on a scale | Standard Deviation 6.8 |
Comparison: Intervention (Preparation and Completion) versus True Control at 8 weeks95% CI: [-6.2, 2.9]
Comparison: Intervention (Preparation and Completion) versus Attention Control at 8 weeks95% CI: [-8.2, 1]
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preparation and Completion | Functional Status ADL | 8 week follow up | 23.1 units on a scale | Standard Deviation 5.3 |
| Preparation and Completion | Functional Status ADL | 6 week follow up | 23 units on a scale | Standard Deviation 5.7 |
| Preparation and Completion | Functional Status ADL | Baseline | 22.3 units on a scale | Standard Deviation 4.4 |
| Attention Control | Functional Status ADL | 8 week follow up | 21.8 units on a scale | Standard Deviation 4 |
| Attention Control | Functional Status ADL | Baseline | 21.0 units on a scale | Standard Deviation 2.3 |
| Attention Control | Functional Status ADL | 6 week follow up | 24 units on a scale | Standard Deviation 8.1 |
| True Control | Functional Status ADL | 8 week follow up | 29.8 units on a scale | Standard Deviation 8 |
| True Control | Functional Status ADL | 6 week follow up | 30.6 units on a scale | Standard Deviation 8.2 |
| True Control | Functional Status ADL | Baseline | 29.7 units on a scale | Standard Deviation 6.4 |
Comparison: Intervention (Preparation and Completion) versus True Control at 8 weeks95% CI: [-3.2, 5.6]
Comparison: Intervention (Preparation and Completion) versus Attention Control at 8 weeks95% CI: [-5.6, 3.3]
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.
Time frame: Baseline, 6 and 8 week follow ups
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preparation and Completion | POMS Anxiety Sub-scale | 8 week follow up | 4.6 units on a scale | Standard Deviation 3.3 |
| Preparation and Completion | POMS Anxiety Sub-scale | Baseline | 5.0 units on a scale | Standard Deviation 5.5 |
| Preparation and Completion | POMS Anxiety Sub-scale | 6 week follow up | 5.1 units on a scale | Standard Deviation 4.9 |
| Attention Control | POMS Anxiety Sub-scale | 8 week follow up | 4.8 units on a scale | Standard Deviation 5.4 |
| Attention Control | POMS Anxiety Sub-scale | Baseline | 4.1 units on a scale | Standard Deviation 4.1 |
| Attention Control | POMS Anxiety Sub-scale | 6 week follow up | 5.0 units on a scale | Standard Deviation 4 |
| True Control | POMS Anxiety Sub-scale | 8 week follow up | 5.3 units on a scale | Standard Deviation 4.2 |
| True Control | POMS Anxiety Sub-scale | Baseline | 5.3 units on a scale | Standard Deviation 4.4 |
| True Control | POMS Anxiety Sub-scale | 6 week follow up | 5.9 units on a scale | Standard Deviation 4.4 |
Comparison: Intervention (Preparation and Completion) versus True Control at 8 weeks95% CI: [-4.5, 3.4]
Comparison: Intervention versus Attention Control at 8 weeks.95% CI: [-5.1, 3]