Outlook Quality of Life Intervention

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00784095
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 7.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer; Congestive Heart Failure; Chronic Obstructive Pulmonary Disease	Other: Life completion and preparation; Other: Attention Control	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Outlook: An Intervention to Improve Quality of Life in Serious Illness
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Preparation and Completion 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.	Other: Life completion and preparation; Subjects will discuss life review, issues of forgiveness and heritage and legacy.
Active Comparator: Attention Control 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.	Other: Attention Control; Subjects will listen to a non-guided relaxation CD.
No Intervention: True Control Subjects in the third group ("true control") were exposed to no intervention or attention control.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients with advanced cancer, CHF or COPD.

Exclusion Criteria:

Cognitive impairment, inability to speak, non-English speaking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham VA Medical Center HSR&D COE	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Karen E. Steinhauser, PhD, Durham VA Medical Center HSR&D COE

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00784095
• Other Study ID Numbers: IAD 07-162
• First Posted: Nov 2, 2008
• Last Update Posted: Mar 22, 2016
• Last Verified: Mar 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by VA Office of Research and Development: quality of life
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Heart Failure

Study Results

Participant Flow

Arm/Group Title	Preparation and Completion	Attention Control	True Control
Arm/Group Description	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.	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.	Subjects in the third group ("true control") will be exposed to no intervention or attention control.
Period Title: Overall Study
STARTED	12	12	12
COMPLETED	12	11	11
NOT COMPLETED	0	1	1

Baseline Characteristics

Arm/Group Title	Preparation and Completion	Attention Control	True Control	Total
Arm/Group Description	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.	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.	Subjects in the third group ("true control") will be exposed to no intervention or attention control.	Total of all reporting groups
Overall Participants	12	12	12	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (10)	68 (10)	69 (14)	67 (11)
Sex: Female, Male (Count of Participants)
Female	0 0%	1 8.3%	0 0%	1 2.8%
Male	12 100%	11 91.7%	12 100%	35 97.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	5 41.7%	5 41.7%	4 33.3%	14 38.9%
White	7 58.3%	5 41.7%	5 41.7%	17 47.2%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	2 16.7%	3 25%	5 13.9%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	12 100%	36 100%

Outcome Measures

1. Primary Outcome

Title	Quality of Life - Preparation
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Preparation and Completion	Attention Control	True Control
Arm/Group Description	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.	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.	Subjects in the third group ("true control") will be exposed to no intervention or attention control.
Measure Participants	12	11	11
Baseline	14.4 (3.9)	16.0 (3.7)	15.4 (4.4)
6 week follow up	15.2 (3.8)	14.8 (5.1)	14.5 (3.9)
8 week follow up	16.3 (2.7)	16.1 (4.6)	14.5 (4.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preparation and Completion, True Control
	Comments	Intervention (Preparation and Completion) versus True Control at 8 weeks
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.047
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.9
	Confidence Interval	(2-Sided) 95%; .04 to 5.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Preparation and Completion, Attention Control
	Comments	Intervention (Preparation and Completion) versus Attention Control at 8 weeks
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; -1.1 to 4.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Functional Status ADL
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Preparation and Completion	Attention Control	True Control
Arm/Group Description	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. Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.	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. Attention Control: Subjects will listen to a non-guided relaxation CD.	Subjects in the third group ("true control") were exposed to no intervention or attention control.
Measure Participants	12	11	11
Baseline	22.3 (4.4)	21.0 (2.3)	29.7 (6.4)
6 week follow up	23 (5.7)	24 (8.1)	30.6 (8.2)
8 week follow up	23.1 (5.3)	21.8 (4.0)	29.8 (8.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preparation and Completion, True Control
	Comments	Intervention (Preparation and Completion) versus True Control at 8 weeks
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -3.2 to 5.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Preparation and Completion, Attention Control
	Comments	Intervention (Preparation and Completion) versus Attention Control at 8 weeks
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.1
	Confidence Interval	(2-Sided) 95%; -5.6 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Center for Epidemiology Studies - Depression Scale (CES-D)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Preparation and Completion	Attention Control	True Control
Arm/Group Description	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. Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.	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. Attention Control: Subjects will listen to a non-guided relaxation CD.	Subjects in the third group ("true control") were exposed to no intervention or attention control.
Measure Participants	12	11	11
Baseline	12.0 (5.0)	12.0 (8.3)	13.4 (6.6)
6 week follow up	12.4 (5.4)	12.6 (7.7)	12.3 (6.8)
8 week follow up	9.4 (4.2)	12.5 (8.9)	12.1 (5.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preparation and Completion, True Control
	Comments	Intervention (Preparation and Completion) versus True Control at 8 weeks
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.6
	Confidence Interval	(2-Sided) 95%; -6.2 to 2.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Preparation and Completion, Attention Control
	Comments	Intervention (Preparation and Completion) versus Attention Control at 8 weeks
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.6
	Confidence Interval	(2-Sided) 95%; -8.2 to 1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	POMS Anxiety Sub-scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Preparation and Completion	Attention Control	True Control
Arm/Group Description	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. Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.	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. Attention Control: Subjects will listen to a non-guided relaxation CD.	Subjects in the third group ("true control") were exposed to no intervention or attention control.
Measure Participants	12	11	11
Baseline	5.0 (5.5)	4.1 (4.1)	5.3 (4.4)
6 week follow up	5.1 (4.9)	5.0 (4.0)	5.9 (4.4)
8 week follow up	4.6 (3.3)	4.8 (5.4)	5.3 (4.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preparation and Completion, True Control
	Comments	Intervention (Preparation and Completion) versus True Control at 8 weeks
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -4.5 to 3.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Preparation and Completion, Attention Control
	Comments	Intervention versus Attention Control at 8 weeks.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.1
	Confidence Interval	(2-Sided) 95%; -5.1 to 3.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Primary Outcome

Title	QUAL-E Completion Sub-scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Preparation and Completion	Attention Control	True Control
Arm/Group Description	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. Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.	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. Attention Control: Subjects will listen to a non-guided relaxation CD.	Subjects in the third group ("true control") were exposed to no intervention or attention control.
Measure Participants	12	11	11
Baseline	22.4 (6.5)	24.5 (5.2)	22.5 (6.9)
6 week follow up	22.6 (5.6)	25.3 (5.2)	23.1 (6.1)
8 week follow up	23.4 (5.6)	24.1 (5.9)	24.4 (7.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preparation and Completion, True Control
	Comments	Intervention (Preparation and Completion) versus True Control at 8 weeks
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-.6
	Confidence Interval	(2-Sided) 95%; -4.8 to 3.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Preparation and Completion, Attention Control
	Comments	Intervention (Preparation and Completion) versus Attention Control at 8 weeks.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95%; -1.9 to 6.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Preparation and Completion		Attention Control		True Control
Arm/Group Description	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.		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.		Subjects in the third group ("true control") were exposed to no intervention or attention control.
All Cause Mortality
	Preparation and Completion		Attention Control		True Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Preparation and Completion		Attention Control		True Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		1/12 (8.3%)		0/12 (0%)
General disorders
Death	0/12 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Other (Not Including Serious) Adverse Events
	Preparation and Completion		Attention Control		True Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.