Trial Outcomes & Findings for Outlook Quality of Life Intervention Study (NCT NCT01044290)
NCT ID: NCT01044290
Last Updated: 2015-11-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
221 participants
Primary outcome timeframe
Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)
Results posted on
2015-11-20
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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
|
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.
|
|---|---|---|---|
|
Randomization
STARTED
|
75
|
74
|
72
|
|
Randomization
Randomized
|
75
|
74
|
72
|
|
Randomization
COMPLETED
|
75
|
74
|
72
|
|
Randomization
NOT COMPLETED
|
0
|
0
|
0
|
|
Follow-up 1
STARTED
|
75
|
74
|
72
|
|
Follow-up 1
Completed F1 Interview
|
61
|
60
|
61
|
|
Follow-up 1
COMPLETED
|
70
|
69
|
71
|
|
Follow-up 1
NOT COMPLETED
|
5
|
5
|
1
|
|
Follow-Up 2
STARTED
|
70
|
69
|
71
|
|
Follow-Up 2
Completed F2 Interview
|
64
|
57
|
64
|
|
Follow-Up 2
COMPLETED
|
70
|
67
|
69
|
|
Follow-Up 2
NOT COMPLETED
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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
|
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.
|
|---|---|---|---|
|
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
Outlook Quality of Life Intervention Study
Baseline characteristics by cohort
| Measure |
Arm 1 -Outlook Intervention
n=75 Participants
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.
|
Arm 2 Attention Control
n=74 Participants
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
|
Arm 3 Treatment as Usual
n=72 Participants
Subjects in the third group ("Treatment as Usual") were exposed to no intervention or attention control during the intervention window.
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.7 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
68.2 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
66.4 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
212 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
218 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
74 participants
n=7 Participants
|
72 participants
n=5 Participants
|
221 participants
n=4 Participants
|
|
Palliative Performance Scale - Stratification variable
High (greater or = 70)
|
55 participants
n=5 Participants
|
55 participants
n=7 Participants
|
54 participants
n=5 Participants
|
164 participants
n=4 Participants
|
|
Palliative Performance Scale - Stratification variable
Low (less or = 60)
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
18 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
Highest level of Education
Less than High School (HS) degree
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Highest level of Education
HS degree or GED
|
25 participants
n=5 Participants
|
29 participants
n=7 Participants
|
25 participants
n=5 Participants
|
79 participants
n=4 Participants
|
|
Highest level of Education
Some college, associate, trade school
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
24 participants
n=5 Participants
|
84 participants
n=4 Participants
|
|
Highest level of Education
Bachelor's degree
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Highest level of Education
some graduate/professional or higher degree
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Religion
Christian
|
72 participants
n=5 Participants
|
69 participants
n=7 Participants
|
62 participants
n=5 Participants
|
203 participants
n=4 Participants
|
|
Religion
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Religion
Not a member of a religion
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Religion
Missing
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Financial Status
Difficulty paying the bills
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
10 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
Financial Status
Money to pay bills but need to cut back
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
58 participants
n=4 Participants
|
|
Financial Status
Pay bills but little spare money
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
22 participants
n=5 Participants
|
72 participants
n=4 Participants
|
|
Financial Status
Have enough money for special things
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
21 participants
n=5 Participants
|
55 participants
n=4 Participants
|
|
Working Status
Working for pay, part or full-time
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
4 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Working Status
Not working
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Working Status
Retired
|
44 participants
n=5 Participants
|
41 participants
n=7 Participants
|
41 participants
n=5 Participants
|
126 participants
n=4 Participants
|
|
Working Status
Disability
|
23 participants
n=5 Participants
|
20 participants
n=7 Participants
|
18 participants
n=5 Participants
|
61 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1 -Outlook Intervention
n=75 Participants
Participants received the Outlook Intervention
|
Arm 2 Attention Control
n=74 Participants
Participants received a relaxation meditation as attention control
|
Arm 3 Treatment as Usual
n=72 Participants
Participants received no intervention, but rather care as usual
|
|---|---|---|---|
|
QUAL-E - Preparation Sub-scale
Baseline mean
|
15.7 units on a scale
Standard Deviation 3.3
|
14.5 units on a scale
Standard Deviation 3.5
|
14.8 units on a scale
Standard Deviation 3.9
|
|
QUAL-E - Preparation Sub-scale
5 week follow up
|
16.0 units on a scale
Standard Deviation 3.1
|
15.5 units on a scale
Standard Deviation 3.3
|
14.4 units on a scale
Standard Deviation 3.9
|
|
QUAL-E - Preparation Sub-scale
7 week follow up
|
15.5 units on a scale
Standard Deviation 3.2
|
15.2 units on a scale
Standard Deviation 3.5
|
14.6 units on a scale
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1 -Outlook Intervention
n=75 Participants
Participants received the Outlook Intervention
|
Arm 2 Attention Control
n=74 Participants
Participants received a relaxation meditation as attention control
|
Arm 3 Treatment as Usual
n=72 Participants
Participants received no intervention, but rather care as usual
|
|---|---|---|---|
|
QUAL-E Life Completion Sub-scale
Baseline
|
26.0 units on a scale
Standard Deviation 5.3
|
26.4 units on a scale
Standard Deviation 5.7
|
25.8 units on a scale
Standard Deviation 5.4
|
|
QUAL-E Life Completion Sub-scale
5 weeks
|
26.6 units on a scale
Standard Deviation 4.6
|
26.4 units on a scale
Standard Deviation 5.7
|
25.6 units on a scale
Standard Deviation 6.0
|
|
QUAL-E Life Completion Sub-scale
7 weeks
|
26.1 units on a scale
Standard Deviation 5.1
|
27.5 units on a scale
Standard Deviation 4.9
|
25.6 units on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1 -Outlook Intervention
n=75 Participants
Participants received the Outlook Intervention
|
Arm 2 Attention Control
n=74 Participants
Participants received a relaxation meditation as attention control
|
Arm 3 Treatment as Usual
n=72 Participants
Participants received no intervention, but rather care as usual
|
|---|---|---|---|
|
POMS Anxiety Sub-scale
7 Weeks
|
5.9 units on a scale
Standard Deviation 4.1
|
5.3 units on a scale
Standard Deviation 3.8
|
6.7 units on a scale
Standard Deviation 4.7
|
|
POMS Anxiety Sub-scale
Baseline
|
5.5 units on a scale
Standard Deviation 4.5
|
5.9 units on a scale
Standard Deviation 4.1
|
6.5 units on a scale
Standard Deviation 4.6
|
|
POMS Anxiety Sub-scale
5 Weeks
|
5.4 units on a scale
Standard Deviation 3.8
|
5.6 units on a scale
Standard Deviation 4.1
|
5.9 units on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1 -Outlook Intervention
n=75 Participants
Participants received the Outlook Intervention
|
Arm 2 Attention Control
n=74 Participants
Participants received a relaxation meditation as attention control
|
Arm 3 Treatment as Usual
n=72 Participants
Participants received no intervention, but rather care as usual
|
|---|---|---|---|
|
CES-D
Baseline
|
7.9 units on a scale
Standard Deviation 5.4
|
8.9 units on a scale
Standard Deviation 5.8
|
9.4 units on a scale
Standard Deviation 6.1
|
|
CES-D
5 week
|
8.1 units on a scale
Standard Deviation 5.0
|
8.4 units on a scale
Standard Deviation 5.2
|
9.2 units on a scale
Standard Deviation 6.5
|
|
CES-D
7 Week
|
8.8 units on a scale
Standard Deviation 5.1
|
9.2 units on a scale
Standard Deviation 6.3
|
9.6 units on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1 -Outlook Intervention
n=75 Participants
Participants received the Outlook Intervention
|
Arm 2 Attention Control
n=74 Participants
Participants received a relaxation meditation as attention control
|
Arm 3 Treatment as Usual
n=72 Participants
Participants received no intervention, but rather care as usual
|
|---|---|---|---|
|
FACIT-SP
Baselin
|
34.5 units on a scale
Standard Deviation 8.0
|
33.6 units on a scale
Standard Deviation 9.1
|
32.8 units on a scale
Standard Deviation 8.8
|
|
FACIT-SP
5 Weeks
|
34.6 units on a scale
Standard Deviation 7.6
|
33.8 units on a scale
Standard Deviation 8.5
|
33.9 units on a scale
Standard Deviation 9.6
|
|
FACIT-SP
7 Weeks
|
34.8 units on a scale
Standard Deviation 8.0
|
34.2 units on a scale
Standard Deviation 8.4
|
33.9 units on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1 -Outlook Intervention
n=75 Participants
Participants received the Outlook Intervention
|
Arm 2 Attention Control
n=74 Participants
Participants received a relaxation meditation as attention control
|
Arm 3 Treatment as Usual
n=72 Participants
Participants received no intervention, but rather care as usual
|
|---|---|---|---|
|
FACT-G - Social Sub-scale
Baseline
|
18.0 units on a scale
Standard Deviation 4.9
|
17.4 units on a scale
Standard Deviation 4.5
|
17.4 units on a scale
Standard Deviation 5.1
|
|
FACT-G - Social Sub-scale
5 Weeks
|
18.4 units on a scale
Standard Deviation 5.2
|
17.6 units on a scale
Standard Deviation 4.8
|
17.1 units on a scale
Standard Deviation 5.0
|
|
FACT-G - Social Sub-scale
7 Weeks
|
18.5 units on a scale
Standard Deviation 4.6
|
18.3 units on a scale
Standard Deviation 4.7
|
16.7 units on a scale
Standard Deviation 5.7
|
Adverse Events
Outlook Intervention
Serious events: 12 serious events
Other events: 6 other events
Deaths: 0 deaths
Attention Control
Serious events: 16 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 13 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Outlook Intervention
n=75 participants at risk
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.
|
Attention Control
n=74 participants at risk
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.
|
Treatment as Usual
n=72 participants at risk
Subjects in the third group ("treatment as usual") will be exposed to no intervention or attention control during the intervention window.
|
|---|---|---|---|
|
Cardiac disorders
cardiac
|
4.0%
3/75 • Number of events 3
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
0.00%
0/74
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
1.4%
1/72 • Number of events 1
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
|
General disorders
death
|
4.0%
3/75 • Number of events 3
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
4.1%
3/74 • Number of events 3
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
2.8%
2/72 • Number of events 2
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
|
General disorders
general
|
1.3%
1/75 • Number of events 1
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
4.1%
3/74 • Number of events 3
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
1.4%
1/72 • Number of events 1
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
neoplasm
|
1.3%
1/75 • Number of events 1
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
5.4%
4/74 • Number of events 4
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
1.4%
1/72 • Number of events 1
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
|
Surgical and medical procedures
procedural complicaton
|
1.3%
1/75 • Number of events 1
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
1.4%
1/74 • Number of events 1
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
4.2%
3/72 • Number of events 3
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
|
Psychiatric disorders
psychiatric
|
1.3%
1/75 • Number of events 1
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
0.00%
0/74
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
0.00%
0/72
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
|
Surgical and medical procedures
surgery
|
2.7%
2/75 • Number of events 2
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
1.4%
1/74 • Number of events 1
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
1.4%
1/72 • Number of events 1
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory
|
0.00%
0/75
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
2.7%
2/74 • Number of events 2
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
4.2%
3/72 • Number of events 3
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
|
Skin and subcutaneous tissue disorders
skin
|
0.00%
0/75
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
1.4%
1/74 • Number of events 1
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
0.00%
0/72
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
|
Renal and urinary disorders
renal
|
0.00%
0/75
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
0.00%
0/74
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
1.4%
1/72 • Number of events 1
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
|
Vascular disorders
vascular
|
0.00%
0/75
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
1.4%
1/74 • Number of events 1
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
0.00%
0/72
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
Other adverse events
| Measure |
Outlook Intervention
n=75 participants at risk
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.
|
Attention Control
n=74 participants at risk
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.
|
Treatment as Usual
n=72 participants at risk
Subjects in the third group ("treatment as usual") will be exposed to no intervention or attention control during the intervention window.
|
|---|---|---|---|
|
Psychiatric disorders
psychiatric
|
4.0%
3/75 • Number of events 3
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
6.8%
5/74 • Number of events 5
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
2.8%
2/72 • Number of events 2
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
|
Infections and infestations
infection
|
4.0%
3/75 • Number of events 3
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
4.1%
3/74 • Number of events 3
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
5.6%
4/72 • Number of events 4
Adverse events were reported according to organ system rather than specific condition. Thus "cardiac" might include myocardial infarction as well as other cardiac events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place